ROMULUS: A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01691898
Collaborator
(none)
231
41
6
76.4
5.6
0.1

Study Details

Study Description

Brief Summary

This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma (DLBCL).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
231 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
Actual Study Start Date :
Sep 27, 2012
Actual Primary Completion Date :
Mar 8, 2017
Actual Study Completion Date :
Feb 7, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab

For the first 2 cycles, RTX 375 milligrams per square meter (mg/m^2) will be given by intravenous (IV) infusion on Day 1 and pinatuzumab vedotin 2.4 milligrams per kilogram (mg/kg) will be administered by IV infusion on Day 2 to Arm A participants (with r/r FL and DLBCL). In the absence of any infusion-related adverse events, RTX and pinatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle. Participants who develop disease progression (PD) will be further treated with RTX 375 mg/m^2 followed by polatuzumab vedotin 2.4 mg/kg IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event relative to the tumor assessment, documenting PD on the initial study treatment, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (17 cycles on an every-21-day schedule).

Drug: Pinatuzumab Vedotin
Pinatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Other Names:
  • DCDT2980S
  • Drug: Polatuzumab Vedotin
    Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
    Other Names:
  • DCDS4501A
  • Drug: Rituximab
    RTX 375 mg/m^2 administered by IV infusion on Day 1 of every 21-day cycle.
    Other Names:
  • MabThera/Rituxan
  • Experimental: Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab

    For the first 2 cycles, RTX 375 mg/m^2 will be given by IV infusion on Day 1 and polatuzumab vedotin 2.4 mg/kg will be administered by IV infusion on Day 2 to Arm B participants (with r/r FL and DLBCL). In the absence of any infusion-related adverse events, RTX and polatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle. Participants who develop PD would be further treated with RTX 375 mg/m^2 followed by pinatuzumab vedotin 2.4 mg/kg IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event relative to the tumor assessment, documenting PD on the initial study treatment, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (17 cycles on an every-21-day schedule).

    Drug: Pinatuzumab Vedotin
    Pinatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
    Other Names:
  • DCDT2980S
  • Drug: Polatuzumab Vedotin
    Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
    Other Names:
  • DCDS4501A
  • Drug: Rituximab
    RTX 375 mg/m^2 administered by IV infusion on Day 1 of every 21-day cycle.
    Other Names:
  • MabThera/Rituxan
  • Experimental: Cohort C (FL): RTX + Polatuzumab

    For the first 2 cycles, RTX 375 mg/m^2 will be given by IV infusion on Day 1 and polatuzumab vedotin 1.8 mg/kg will be administered by IV infusion on Day 2 to Cohort C participants (with r/r FL). In the absence of any infusion-related adverse events, RTX and polatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, PD, or withdrawal from study.

    Drug: Polatuzumab Vedotin
    Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
    Other Names:
  • DCDS4501A
  • Drug: Rituximab
    RTX 375 mg/m^2 administered by IV infusion on Day 1 of every 21-day cycle.
    Other Names:
  • MabThera/Rituxan
  • Experimental: Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab

    For the first cycle, obinutuzumab will be given by IV infusion on Days 1, 8, and 15. Polatuzumab vedotin 1.8 mg/kg IV infusion will be given on Day 2 of the first cycle to Cohort E participants (with r/r FL and DLBCL). In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin may be administered on the same day (Day 1) in subsequent cycles beginning with the second cycle up to a maximum of 8 cycles or significant toxicity, PD, or withdrawal from study.

    Drug: Obinutuzumab
    Obinutuzumab 1000 mg will be administered by IV infusion on Days 1, 8, 15 of first 21-Day cycle and on Day 1 of subsequent 21-day cycles for up to 8 cycles.
    Other Names:
  • GA101, Gazyva, Gazyvaro
  • Drug: Polatuzumab Vedotin
    Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
    Other Names:
  • DCDS4501A
  • Experimental: Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab

    For the first cycle, obinutuzumab will be given by IV infusion on Days 1, 8, and 15. Polatuzumab vedotin 1.8 mg/kg IV infusion will be given on Day 2 of the first cycle to Cohort G participants (with r/r FL). In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin may be administered on the same day (Day 1) in subsequent cycles beginning with the second cycle of the dose-expansion period to cohort G participants up to a maximum of 8 cycles or significant toxicity, PD, or withdrawal from study.

    Drug: Obinutuzumab
    Obinutuzumab 1000 mg will be administered by IV infusion on Days 1, 8, 15 of first 21-Day cycle and on Day 1 of subsequent 21-day cycles for up to 8 cycles.
    Other Names:
  • GA101, Gazyva, Gazyvaro
  • Drug: Polatuzumab Vedotin
    Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
    Other Names:
  • DCDS4501A
  • Experimental: Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab

    For the first cycle, obinutuzumab will be given by IV infusion on Days 1, 8, and 15. Polatuzumab vedotin 1.8 mg/kg IV infusion will be given on Day 2 of the first cycle to Cohort H participants (with r/r DLBCL). In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin may be administered on the same day (Day 1) in subsequent cycles beginning with the second cycle of the dose-expansion period to cohort H participants up to a maximum of 8 cycles or significant toxicity, PD, or withdrawal from study.

    Drug: Obinutuzumab
    Obinutuzumab 1000 mg will be administered by IV infusion on Days 1, 8, 15 of first 21-Day cycle and on Day 1 of subsequent 21-day cycles for up to 8 cycles.
    Other Names:
  • GA101, Gazyva, Gazyvaro
  • Drug: Polatuzumab Vedotin
    Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
    Other Names:
  • DCDS4501A
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) [Baseline up to 12 months after the last dose of study treatment (up to approximately 3.5 years)]

      Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments greater than or equal to (>/=) 4 weeks after initial documentation. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50 percent (%) decrease in sum of the products of greatest diameters (SPD) of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. Participants with insufficient data to determine response were classified as non-responders.

    2. Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) [First occurrence of objective response up to PD/relapse or death due to any cause, whichever occurred first (up to approximately 3.5 years)]

      Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014). DOR was defined as the time from the initial documentation of a CR or PR to the time of PD or death. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.

    3. Percentage of Participants With CR at End of Treatment (EOT) Based on Positron Emission Tomographic/Computed Tomography (PET/CT) Assessment Determined by Independent Review Committee (IRC) Per Lugano 2014 Response Criteria: Cohorts E, G, and H [6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)]

      Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [</=] mediastinum), or 3 (uptake less than [<] mediastinum but </=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.

    Secondary Outcome Measures

    1. Number of Participants With Anti-Drug Antibodies (ADA) to Pinatuzumab Vedotin [Baseline, post-baseline (up to approximately 5.5 years)]

      Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against pinatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.

    2. Number of Participants With ADA to Polatuzumab Vedotin [Baseline, post-baseline (up to approximately 5.5 years)]

      Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against polatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.

    3. Number of Participants With ADA to Obinutuzumab [Baseline, post-baseline (up to approximately 5.5 years)]

      Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against obinutuzumab at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.

    4. Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C) [Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)]

      Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.

    5. Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C) [Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)]

      Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.

    6. Percentage of Participants Who Died Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C) [Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)]

      Percentage of participants who died due to any cause was reported.

    7. Overall Survival (OS): Rituximab Containing Regimens (Arms A and B, Cohort C) [Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)]

      OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.

    8. Percentage of Participants With CR at EOT Based on PET/CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H) [6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)]

      Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

    9. Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H) [6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)]

      Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

    10. Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by the Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H) [6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)]

      Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

    11. Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G) [6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)]

      Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. CR was defined as reduction of longest transverse diameter (LDi) of target nodes/nodal masses to less than or equal to (</=) 1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

    12. Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G) [6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)]

      Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

    13. Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G) [6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)]

      Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

    14. Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G) [6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)]

      Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

    15. Percentage of Participants With Best OR Based on PET/CT or CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H) [Baseline up to disease progression or death, whichever occurred first (up to approximately 5.5 years)]

      Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT or CT scan. Best OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.

    16. Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C) [Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)]

      AUCinf for rituximab was estimated from serum concentration data using non-compartmental analysis.

    17. Maximum Observed Concentration (Cmax) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C) [Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)]

      Cmax for rituximab was estimated from serum concentration data using non-compartmental analysis.

    18. Systemic Clearance (CL) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C) [Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)]

      CL for rituximab was estimated from serum concentration data using non-compartmental analysis.

    19. Half-Life (t1/2) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C) [Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)]

      t1/2 for rituximab was estimated from serum concentration data using non-compartmental analysis. Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days).

    20. Volume of Distribution at Steady State (Vss) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C) [Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)]

      Vss for rituximab was estimated from serum concentration data using non-compartmental analysis. Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)

    21. AUCinf of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUCinf of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with Monomethyl Auristatin E (MMAE)-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

    22. AUCinf of Antibody Conjugated Monomethyl Auristatin E (acMMAE) for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUCinf of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. Antibody conjugated MMAE is the total concentration of MMAE that was conjugated to the antibody.

    23. Area Under the Concentration-Time Curve From Time Zero To Last Measurable Concentration (AUClast) of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUClast of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

    24. Cmax of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

    25. Cmax of acMMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

    26. Cmax of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

    27. AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

    28. AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

    29. AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

    30. Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

    31. Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

    32. Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

    33. AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

    34. AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

    35. AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

    36. Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

    37. Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

    38. Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

    39. AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

    40. AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

    41. AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

    42. Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.

    43. Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.

    44. Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.

    45. Cmax of Obinutuzumab: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G) [Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)]

      Cmax of obinutuzumab was estimated from serum concentration data using non-compartmental analysis.

    46. Overall Survival (OS): Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G) [Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)]

      OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.

    47. Percentage of Participants Who Died Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G) [Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)]

      Percentage of participants who died due to any cause was reported.

    48. Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G) [Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)]

      Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.

    49. Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G) [Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 5.5 years)]

      Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

    • Life expectancy of at least 12 weeks

    • History of histologically documented r/r Grades 1 to 3a FL, or r/r DLBCL

    • Availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment

    • Have a clinical indication for treatment as determined by the investigator

    • Must have at least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters [cm] in its largest dimension by CT scan or Magnetic Resonance Imaging [MRI])

    Exclusion Criteria:
    • Prior use of any monoclonal antibody, radio-immuno-conjugate or antibody drug conjugate within 4 weeks before study start

    • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start

    • Adverse events except for sensory neuropathy from any previous treatments must be resolved or stabilized to Grade less than equal to (</=) 2 prior study start

    • Completion of autologous stem cell transplant (SCT) within 100 days prior study start

    • Prior allogeneic SCT

    • Eligibility for autologous SCT (participants with r/r DLBCL)

    • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)

    • History of other malignancy that could affect compliance with the protocol or interpretation of results

    • Current or past history of central nervous system lymphoma

    • Current Grade >1 peripheral neuropathy

    • Vaccination with a live vaccine within 28 days prior to treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States 90048
    2 Stanford Cancer Center Stanford California United States 94305-5820
    3 Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center Denver Colorado United States 80218
    4 Georgetown University Medical Center Lombardi Cancer Center Washington District of Columbia United States 20007
    5 Florida Cancer Specialists - Fort Myers (Colonial Center Dr) Fort Myers Florida United States 33905
    6 Florida Cancer Specialists; Sarasota Sarasota Florida United States 34232
    7 Univ of Michigan Med School; Hematology Oncology Ann Arbor Michigan United States 48109
    8 Comprehensive Cancer Centers of Nevada - Eastern Avenue Las Vegas Nevada United States 89169
    9 Hematology Oncology Associates; Carol G. Simon Ctr Morristown New Jersey United States 07960
    10 Regional Cancer Care Associates LLC - Morristown Morristown New Jersey United States 07962
    11 Roswell Park Cancer Inst. Buffalo New York United States 14263
    12 New York University Cancer Cen New York New York United States 10016
    13 Oncology Hematology Care Inc Cincinnati Ohio United States 45242
    14 Willamette Valley Cancer Ctr - 520 Country Club Eugene Oregon United States 97401-8122
    15 Oregon Health Sciences Uni Portland Oregon United States 97239
    16 Sarah Cannon Cancer Center - Tennessee Oncology, Pllc Nashville Tennessee United States 37203
    17 Texas Oncology-Baylor Sammons Cancer Center Dallas Texas United States 75246
    18 Cancer Care Centers of South Texas San Antonio Texas United States 78217
    19 Texas Transplant Inst. San Antonio Texas United States 78229
    20 Texas Oncology, P.A. - Tyler; Tyler Cancer Center Tyler Texas United States 75702
    21 Fairfax N Virginia Hem/Onc PC Fairfax Virginia United States 22031
    22 Oncology & Hematolgy Associates of SW Va Inc. - Roanoke Roanoke Virginia United States 24014
    23 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    24 Northwest Cancer Specialists - Vancouver Vancouver Washington United States 98684
    25 Yakima Valley Memorial Hospital/North Star Lodge Yakima Washington United States 98902
    26 Univ of Wisconsin-Madison Madison Wisconsin United States 53705
    27 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    28 British Columbia Cancer Agency Vancouver British Columbia Canada V5Z 1H6
    29 McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology Montreal Quebec Canada H3T 1E2
    30 Hopital Claude Huriez - CHU Lille Lille France 59037
    31 CHU Montpellier - Saint ELOI Montpellier France 34295
    32 Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset) Paris France 75475
    33 Centre Hospitalier Lyon Sud Pierre Benite France 69495
    34 Centre Henri Becquerel; Hematologie Rouen France 76038
    35 Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V Heidelberg Germany 69120
    36 Universitätsmedizin Johannes Gutenberg Universität; Klinik u. Poliklinik f. Neurologie Mainz Germany 55131
    37 Klinikum d.Universität München Campus Großhadern München Germany 81377
    38 A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna Bologna Emilia-Romagna Italy 40138
    39 Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 Milano Lombardia Italy 20133
    40 Azienda Ospedale San Giovanni Torino Piemonte Italy 10126
    41 Academisch Medisch Centrum; Hematologie Amsterdam Netherlands 1105 AZ

    Sponsors and Collaborators

    • Genentech, Inc.

    Investigators

    • Study Director: Clinical Trials, Genentech, Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT01691898
    Other Study ID Numbers:
    • GO27834
    • 2011-004377-84
    First Posted:
    Sep 25, 2012
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020

    Study Results

    Participant Flow

    Recruitment Details A total of 289 participants were screened, out of which, 231 participants were enrolled into the study.
    Pre-assignment Detail
    Arm/Group Title Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with relapsed or refractory (r/r) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Period Title: Overall Study
    STARTED 63 59 20 9 40 40
    COMPLETED 16 15 11 4 26 5
    NOT COMPLETED 47 44 9 5 14 35

    Baseline Characteristics

    Arm/Group Title Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab Total
    Arm/Group Description Participants with relapsed or refractory [r/r] FL and DLBCL received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Total of all reporting groups
    Overall Participants 63 59 20 9 40 40 231
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    29
    46%
    25
    42.4%
    12
    60%
    4
    44.4%
    23
    57.5%
    16
    40%
    109
    47.2%
    >=65 years
    34
    54%
    34
    57.6%
    8
    40%
    5
    55.6%
    17
    42.5%
    24
    60%
    122
    52.8%
    Sex: Female, Male (Count of Participants)
    Female
    27
    42.9%
    24
    40.7%
    8
    40%
    2
    22.2%
    16
    40%
    18
    45%
    95
    41.1%
    Male
    36
    57.1%
    35
    59.3%
    12
    60%
    7
    77.8%
    24
    60%
    22
    55%
    136
    58.9%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    3.2%
    5
    8.5%
    1
    5%
    0
    0%
    0
    0%
    2
    5%
    10
    4.3%
    Not Hispanic or Latino
    48
    76.2%
    44
    74.6%
    19
    95%
    9
    100%
    33
    82.5%
    36
    90%
    189
    81.8%
    Unknown or Not Reported
    13
    20.6%
    10
    16.9%
    0
    0%
    0
    0%
    7
    17.5%
    2
    5%
    32
    13.9%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
    Description Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments greater than or equal to (>/=) 4 weeks after initial documentation. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50 percent (%) decrease in sum of the products of greatest diameters (SPD) of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. Participants with insufficient data to determine response were classified as non-responders.
    Time Frame Baseline up to 12 months after the last dose of study treatment (up to approximately 3.5 years)

    Outcome Measure Data

    Analysis Population Description
    Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population, which included all participants with baseline measurable disease and at least one post-baseline tumor assessment after study treatment.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 42 21 39 20 20
    Number (90% Confidence Interval) [percentage of participants]
    59.5
    94.4%
    61.9
    104.9%
    53.8
    269%
    70.0
    777.8%
    75.0
    187.5%
    2. Primary Outcome
    Title Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
    Description Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014). DOR was defined as the time from the initial documentation of a CR or PR to the time of PD or death. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.
    Time Frame First occurrence of objective response up to PD/relapse or death due to any cause, whichever occurred first (up to approximately 3.5 years)

    Outcome Measure Data

    Analysis Population Description
    Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population participants who achieved objective response.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 25 13 21 14 15
    Median (Full Range) [months]
    6.24
    6.47
    13.37
    9.36
    12.85
    3. Primary Outcome
    Title Percentage of Participants With CR at End of Treatment (EOT) Based on Positron Emission Tomographic/Computed Tomography (PET/CT) Assessment Determined by Independent Review Committee (IRC) Per Lugano 2014 Response Criteria: Cohorts E, G, and H
    Description Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [</=] mediastinum), or 3 (uptake less than [<] mediastinum but </=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.
    Time Frame 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E (DLBCL): Obinutuzumab + Polatuzumab Cohort E (FL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 4 2 34 27
    Number (90% Confidence Interval) [percentage of participants]
    0
    0%
    50.0
    84.7%
    35.3
    176.5%
    0
    0%
    4. Secondary Outcome
    Title Number of Participants With Anti-Drug Antibodies (ADA) to Pinatuzumab Vedotin
    Description Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against pinatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
    Time Frame Baseline, post-baseline (up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on safety-evaluable population (only participants who received pinatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.
    Arm/Group Title Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
    Arm/Group Description Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 60 1
    Baseline
    2
    3.2%
    Post-baseline
    0
    0%
    0
    0%
    5. Secondary Outcome
    Title Number of Participants With ADA to Polatuzumab Vedotin
    Description Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against polatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
    Time Frame Baseline, post-baseline (up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on safety-evaluable population (only participants who received polatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.
    Arm/Group Title Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 2 59 20 8 37 36
    Baseline
    1
    1.6%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Post-baseline
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    6. Secondary Outcome
    Title Number of Participants With ADA to Obinutuzumab
    Description Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against obinutuzumab at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
    Time Frame Baseline, post-baseline (up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on safety-evaluable population (only participants who received obinutuzumab). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.
    Arm/Group Title Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 9 37 39
    Baseline
    1
    1.6%
    2
    3.4%
    0
    0%
    Post-baseline
    0
    0%
    0
    0%
    0
    0%
    7. Secondary Outcome
    Title Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)
    Description Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.
    Time Frame Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 42 21 39 20 20
    Number [percentage of participants]
    85.7
    136%
    52.4
    88.8%
    76.9
    384.5%
    55.0
    611.1%
    60.0
    150%
    8. Secondary Outcome
    Title Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)
    Description Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
    Time Frame Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 42 21 39 20 20
    Median (95% Confidence Interval) [months]
    5.388
    12.682
    5.552
    15.277
    18.103
    9. Secondary Outcome
    Title Percentage of Participants Who Died Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)
    Description Percentage of participants who died due to any cause was reported.
    Time Frame Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 42 21 39 20 20
    Number [percentage of participants]
    66.7
    105.9%
    23.8
    40.3%
    61.5
    307.5%
    15.0
    166.7%
    20.0
    50%
    10. Secondary Outcome
    Title Overall Survival (OS): Rituximab Containing Regimens (Arms A and B, Cohort C)
    Description OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
    Time Frame Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 42 21 39 20 20
    Median (95% Confidence Interval) [months]
    16.493
    NA
    18.760
    NA
    NA
    11. Secondary Outcome
    Title Percentage of Participants With CR at EOT Based on PET/CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
    Description Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
    Time Frame 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E (DLBCL): Obinutuzumab + Polatuzumab Cohort E (FL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 4 3 36 33
    Number (90% Confidence Interval) [percentage of participants]
    25.0
    39.7%
    66.7
    113.1%
    33.3
    166.5%
    15.2
    168.9%
    12. Secondary Outcome
    Title Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
    Description Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
    Time Frame 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E (DLBCL): Obinutuzumab + Polatuzumab Cohort E (FL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 4 2 34 27
    Number (90% Confidence Interval) [percentage of participants]
    25.0
    39.7%
    100.0
    169.5%
    64.7
    323.5%
    18.5
    205.6%
    13. Secondary Outcome
    Title Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by the Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
    Description Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
    Time Frame 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E (DLBCL): Obinutuzumab + Polatuzumab Cohort E (FL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 4 3 36 33
    Number (90% Confidence Interval) [percentage of participants]
    25.0
    39.7%
    66.7
    113.1%
    63.9
    319.5%
    21.2
    235.6%
    14. Secondary Outcome
    Title Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
    Description Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. CR was defined as reduction of longest transverse diameter (LDi) of target nodes/nodal masses to less than or equal to (</=) 1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
    Time Frame 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 31 36
    Number (90% Confidence Interval) [percentage of participants]
    6.5
    10.3%
    13.9
    23.6%
    15. Secondary Outcome
    Title Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
    Description Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
    Time Frame 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 37 39
    Number (90% Confidence Interval) [percentage of participants]
    10.8
    17.1%
    20.5
    34.7%
    16. Secondary Outcome
    Title Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
    Description Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
    Time Frame 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 31 36
    Number (90% Confidence Interval) [percentage of participants]
    25.8
    41%
    66.7
    113.1%
    17. Secondary Outcome
    Title Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
    Description Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
    Time Frame 6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 37 39
    Number (90% Confidence Interval) [percentage of participants]
    21.6
    34.3%
    64.1
    108.6%
    18. Secondary Outcome
    Title Percentage of Participants With Best OR Based on PET/CT or CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)
    Description Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT or CT scan. Best OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.
    Time Frame Baseline up to disease progression or death, whichever occurred first (up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E (DLBCL): Obinutuzumab + Polatuzumab Cohort E (FL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 5 4 39 39
    Number (90% Confidence Interval) [percentage of participants]
    20.0
    31.7%
    50.0
    84.7%
    74.4
    372%
    43.6
    484.4%
    19. Secondary Outcome
    Title Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
    Description AUCinf for rituximab was estimated from serum concentration data using non-compartmental analysis.
    Time Frame Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)

    Outcome Measure Data

    Analysis Population Description
    Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable pharmacokinetic (PK) concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 25 15 26 11 15
    Mean (Standard Deviation) [day*micrograms (mcg)/milliliter (mL)]
    5640
    (8320)
    3350
    (1180)
    4200
    (2620)
    3910
    (2480)
    2660
    (879)
    20. Secondary Outcome
    Title Maximum Observed Concentration (Cmax) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
    Description Cmax for rituximab was estimated from serum concentration data using non-compartmental analysis.
    Time Frame Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)

    Outcome Measure Data

    Analysis Population Description
    Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 36 18 35 16 18
    Mean (Standard Deviation) [mcg/mL]
    217
    (61.5)
    225
    (40.9)
    232
    (72.7)
    228
    (83.3)
    227
    (32.4)
    21. Secondary Outcome
    Title Systemic Clearance (CL) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
    Description CL for rituximab was estimated from serum concentration data using non-compartmental analysis.
    Time Frame Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)

    Outcome Measure Data

    Analysis Population Description
    Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 25 15 26 11 15
    Mean (Standard Deviation) [mL/day/meter-square (m^2)]
    113.97
    (61.41)
    124.53
    (41.12)
    116.26
    (59.99)
    134.31
    (97.45)
    158.57
    (60.47)
    22. Secondary Outcome
    Title Half-Life (t1/2) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
    Description t1/2 for rituximab was estimated from serum concentration data using non-compartmental analysis. Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days).
    Time Frame Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)

    Outcome Measure Data

    Analysis Population Description
    Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 25 15 26 11 15
    Mean (Standard Deviation) [days]
    35.3
    (56.3)
    18.7
    (6.23)
    25.6
    (18.0)
    19.8
    (7.34)
    14.4
    (3.62)
    23. Secondary Outcome
    Title Volume of Distribution at Steady State (Vss) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)
    Description Vss for rituximab was estimated from serum concentration data using non-compartmental analysis. Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)
    Time Frame Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)

    Outcome Measure Data

    Analysis Population Description
    Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 25 15 26 11 15
    Mean (Standard Deviation) [mL/m^2]
    2901.85
    (1009.31)
    2802.96
    (678.33)
    2988.90
    (788.89)
    2839.26
    (730.10)
    2654.46
    (413.19)
    24. Secondary Outcome
    Title AUCinf of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description AUCinf of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with Monomethyl Auristatin E (MMAE)-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 27 15
    Mean (Standard Deviation) [day*mcg/mL]
    309
    (67.7)
    315
    (111)
    25. Secondary Outcome
    Title AUCinf of Antibody Conjugated Monomethyl Auristatin E (acMMAE) for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description AUCinf of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. Antibody conjugated MMAE is the total concentration of MMAE that was conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 39 17
    Mean (Standard Deviation) [day*nanogram (ng)/mL]
    2840
    (555)
    3110
    (828)
    26. Secondary Outcome
    Title Area Under the Concentration-Time Curve From Time Zero To Last Measurable Concentration (AUClast) of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description AUClast of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 39 21
    Mean (Standard Deviation) [day*ng/mL]
    34.2
    (24.0)
    33.5
    (17.5)
    27. Secondary Outcome
    Title Cmax of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description Cmax of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 39 20
    Mean (Standard Deviation) [mcg/mL]
    42.5
    (11.6)
    48.3
    (9.34)
    28. Secondary Outcome
    Title Cmax of acMMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description Cmax of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 38 21
    Mean (Standard Deviation) [ng/mL]
    850
    (222)
    994
    (190)
    29. Secondary Outcome
    Title Cmax of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description Cmax of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations.
    Arm/Group Title Arm A (DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm A (FL): RTX+Pinatuzumab,Then RTX+Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 39 21
    Mean (Standard Deviation) [ng/mL]
    4.39
    (3.15)
    4.20
    (2.32)
    30. Secondary Outcome
    Title AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 26 17
    Mean (Standard Deviation) [day*mcg/mL]
    412
    (108)
    428
    (106)
    31. Secondary Outcome
    Title AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 30 17
    Mean (Standard Deviation) [day*ng/mL]
    3660
    (843)
    3510
    (1160)
    32. Secondary Outcome
    Title AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations.
    Arm/Group Title Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 39 18
    Mean (Standard Deviation) [day*ng/mL]
    31.7
    (17.2)
    29.5
    (25.0)
    33. Secondary Outcome
    Title Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 38 16
    Mean (Standard Deviation) [mcg/mL]
    51.9
    (12.3)
    55.9
    (12.8)
    34. Secondary Outcome
    Title Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 38 17
    Mean (Standard Deviation) [ng/mL]
    948
    (204)
    968
    (268)
    35. Secondary Outcome
    Title Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab
    Description Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations.
    Arm/Group Title Arm B (DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Arm B (FL): RTX+Polatuzumab,Then RTX+Pinatuzumab
    Arm/Group Description Participants with r/r DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule).
    Measure Participants 39 18
    Mean (Standard Deviation) [ng/mL]
    3.72
    (1.98)
    3.29
    (2.71)
    36. Secondary Outcome
    Title AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
    Description AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 17
    Mean (Standard Deviation) [day*mcg/mL]
    258
    (84.1)
    37. Secondary Outcome
    Title AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
    Description AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 15
    Mean (Standard Deviation) [day*ng/mL]
    2600
    (630)
    38. Secondary Outcome
    Title AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
    Description AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations.
    Arm/Group Title Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 20
    Mean (Standard Deviation) [day*ng/mL]
    17.7
    (9.39)
    39. Secondary Outcome
    Title Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
    Description Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 19
    Mean (Standard Deviation) [mcg/mL]
    42.2
    (7.92)
    40. Secondary Outcome
    Title Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
    Description Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 17
    Mean (Standard Deviation) [ng/mL]
    787
    (113)
    41. Secondary Outcome
    Title Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab
    Description Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations.
    Arm/Group Title Cohort C (FL): RTX + Polatuzumab
    Arm/Group Description Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 20
    Mean (Standard Deviation) [ng/mL]
    2.02
    (1.34)
    42. Secondary Outcome
    Title AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
    Description AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 27 30
    Mean (Standard Deviation) [day*mcg/mL]
    218
    (89.1)
    215
    (102)
    43. Secondary Outcome
    Title AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
    Description AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 26 29
    Mean (Standard Deviation) [day*ng/mL]
    2440
    (665)
    2340
    (875)
    44. Secondary Outcome
    Title AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
    Description AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 40 41
    Mean (Standard Deviation) [day*ng/mL]
    27.9
    (21.3)
    22.3
    (9.46)
    45. Secondary Outcome
    Title Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
    Description Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 37 38
    Mean (Standard Deviation) [mcg/mL]
    35.0
    (9.89)
    34.2
    (7.89)
    46. Secondary Outcome
    Title Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
    Description Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 33 33
    Mean (Standard Deviation) [ng/mL]
    711
    (155)
    694
    (161)
    47. Secondary Outcome
    Title Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab
    Description Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 40 41
    Mean (Standard Deviation) [ng/mL]
    3.62
    (3.73)
    2.80
    (1.30)
    48. Secondary Outcome
    Title Cmax of Obinutuzumab: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
    Description Cmax of obinutuzumab was estimated from serum concentration data using non-compartmental analysis.
    Time Frame Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all participants who received obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 40 35
    Mean (Standard Deviation) [mcg/mL]
    340
    (95.0)
    330
    (87.9)
    49. Secondary Outcome
    Title Overall Survival (OS): Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)
    Description OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
    Time Frame Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 35 9
    Median (95% Confidence Interval) [Months]
    10.5
    NA
    50. Secondary Outcome
    Title Percentage of Participants Who Died Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
    Description Percentage of participants who died due to any cause was reported.
    Time Frame Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 45 44
    Number [percentage of participants]
    77.8
    123.5%
    20.5
    34.7%
    51. Secondary Outcome
    Title Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
    Description Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.
    Time Frame Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 45 44
    Median (95% Confidence Interval) [months]
    2.7
    19.5
    52. Secondary Outcome
    Title Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)
    Description Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.
    Time Frame Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 5.5 years)

    Outcome Measure Data

    Analysis Population Description
    Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.
    Arm/Group Title Cohort E + Cohort H (DLBCL): Obinutuzumab + Polatuzumab Cohort E + Cohort G (FL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    Measure Participants 45 44
    Number [percentage of participants]
    88.9
    141.1%
    56.8
    96.3%

    Adverse Events

    Time Frame Baseline up to 30 days after the last dose of study treatment (up to approximately 12 months for rituximab-containing regimens [Arms A and B, Cohort C] and 24 weeks for Cohorts E, G, and H)
    Adverse Event Reporting Description Analysis was performed on safety-evaluable population.
    Arm/Group Title Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Arm/Group Description Participants with relapsed or refractory [r/r] FL and DLBCL received rituximab (RTX) at a dose of 375 milligrams per square meter (mg/m^2) administered via intravenous (IV) infusion on Day 1 and pinatuzumab vedotin at a dose of 2.4 milligrams per kilogram (mg/kg) administered via IV infusion on Day 2 for the first 2 cycles. RTX and pinatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed disease progression (PD) were treated with RTX at 375 mg/m^2 and polatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL and DLBCL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 2.4 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle, in the absence of any infusion-related adverse events. Participants who developed PD were treated with RTX at 375 mg/m^2 and pinatuzumab vedotin at 2.4 mg/kg via IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (maximum 17 cycles on an every-21-day schedule). Participants with r/r FL received RTX at a dose of 375 mg/m^2 administered via IV infusion on Day 1 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first 2 cycles. In the absence of any infusion-related adverse events, RTX and polatuzumab were administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL and DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r FL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study. Participants with r/r DLBCL received obinutuzumab at a dose of 1000 mg via IV infusion on Days 1, 8, 15 and polatuzumab vedotin at a dose of 1.8 mg/kg administered via IV infusion on Day 2 for the first cycle. In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin were administered on the same day (Day 1) in subsequent cycles beginning with the second cycle for up to a maximum of 8 cycles or significant toxicity, disease progression, or withdrawal from study.
    All Cause Mortality
    Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 35/63 (55.6%) 33/59 (55.9%) 6/20 (30%) 4/9 (44.4%) 8/40 (20%) 32/40 (80%)
    Serious Adverse Events
    Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 27/63 (42.9%) 21/59 (35.6%) 8/20 (40%) 3/9 (33.3%) 9/40 (22.5%) 18/40 (45%)
    Blood and lymphatic system disorders
    Coagulopathy 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Febrile neutropenia 2/63 (3.2%) 2/59 (3.4%) 2/20 (10%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Thrombocytopenia 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Cardiac disorders
    Atrial fibrillation 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Atrial flutter 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Cardiac failure 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Cardiac failure congestive 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Pericardial effusion 0/63 (0%) 0/59 (0%) 1/20 (5%) 1/9 (11.1%) 0/40 (0%) 0/40 (0%)
    Gastrointestinal disorders
    Abdominal pain 1/63 (1.6%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Abdominal pain lower 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Colonic fistula 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Constipation 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Diarrhoea 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Duodenal perforation 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Dysphagia 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 2/40 (5%)
    Fistula of small intestine 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Gastric perforation 0/63 (0%) 0/59 (0%) 0/20 (0%) 1/9 (11.1%) 0/40 (0%) 0/40 (0%)
    Gastrointestinal haemorrhage 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Hernial eventration 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Nausea 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Pancreatitis 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Rectal haemorrhage 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Subileus 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Upper gastrointestinal haemorrhage 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Vomiting 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    General disorders
    Axillary pain 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Chest discomfort 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Chest pain 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Fatigue 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    General physical health deterioration 2/63 (3.2%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Malaise 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Non-cardiac chest pain 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Pyrexia 2/63 (3.2%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Sudden death 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Hepatobiliary disorders
    Bile duct obstruction 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Cholangitis 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Cholecystitis acute 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Hepatic steatosis 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Hepatocellular injury 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Hepatomegaly 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Hyperbilirubinaemia 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Liver Disorder 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Infections and infestations
    Bronchitis 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Cellulitis 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Clostridial sepsis 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Clostridium difficile infection 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Device related infection 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Febrile infection 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Gastroenteritis 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Herpes zoster 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Influenza 1/63 (1.6%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 0/40 (0%)
    Lung infection 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Pneumonia 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 2/40 (5%) 2/40 (5%)
    Sepsis 3/63 (4.8%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Septic shock 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Sinusitis 0/63 (0%) 0/59 (0%) 0/20 (0%) 1/9 (11.1%) 0/40 (0%) 0/40 (0%)
    Upper respiratory tract infection 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Urinary tract infection 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 2/40 (5%)
    Urosepsis 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Viral diarrhoea 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Injury, poisoning and procedural complications
    Infusion related reaction 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 2/40 (5%) 0/40 (0%)
    Subdural Haematoma 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Wound secretion 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Metabolism and nutrition disorders
    Cachexia 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Dehydration 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Hyperglycaemia 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Tumour lysis syndrome 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Musculoskeletal and connective tissue disorders
    Bone pain 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ganglioneuroma 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Myelodysplastic syndrome 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Nervous system disorders
    Cerebrovascular accident 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Peripheral motor neuropathy 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Syncope 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Hepatic Encephalopathy 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Renal and urinary disorders
    Acute kidney injury 2/63 (3.2%) 2/59 (3.4%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Chronic kidney disease 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Urinary retention 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/63 (1.6%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Lung disorder 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Pleural effusion 0/63 (0%) 0/59 (0%) 0/20 (0%) 1/9 (11.1%) 0/40 (0%) 2/40 (5%)
    Pulmonary congestion 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Pulmonary embolism 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Respiratory failure 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Bronchiectasis 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Vascular disorders
    Hypotension 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Orthostatic hypotension 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Other (Not Including Serious) Adverse Events
    Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab Cohort C (FL): RTX + Polatuzumab Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 63/63 (100%) 58/59 (98.3%) 20/20 (100%) 9/9 (100%) 37/40 (92.5%) 38/40 (95%)
    Blood and lymphatic system disorders
    Anaemia 9/63 (14.3%) 10/59 (16.9%) 1/20 (5%) 2/9 (22.2%) 4/40 (10%) 4/40 (10%)
    Lymphadenopathy 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 0/40 (0%)
    Neutropenia 19/63 (30.2%) 15/59 (25.4%) 8/20 (40%) 4/9 (44.4%) 8/40 (20%) 8/40 (20%)
    Thrombocytopenia 3/63 (4.8%) 2/59 (3.4%) 0/20 (0%) 0/9 (0%) 4/40 (10%) 4/40 (10%)
    Cardiac disorders
    Atrial fibrillation 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 1/9 (11.1%) 1/40 (2.5%) 2/40 (5%)
    Cardiac tamponade 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Pericardial effusion 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Tachycardia 3/63 (4.8%) 3/59 (5.1%) 0/20 (0%) 0/9 (0%) 2/40 (5%) 0/40 (0%)
    Ear and labyrinth disorders
    Ear discomfort 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Ear pain 1/63 (1.6%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Vertigo 2/63 (3.2%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 0/40 (0%)
    Eye disorders
    Dry eye 2/63 (3.2%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 3/40 (7.5%) 0/40 (0%)
    Eye pain 1/63 (1.6%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Lacrimation increased 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Vision blurred 6/63 (9.5%) 2/59 (3.4%) 2/20 (10%) 0/9 (0%) 2/40 (5%) 1/40 (2.5%)
    Visual impairment 1/63 (1.6%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 2/40 (5%) 0/40 (0%)
    Gastrointestinal disorders
    Abdominal discomfort 2/63 (3.2%) 3/59 (5.1%) 1/20 (5%) 0/9 (0%) 1/40 (2.5%) 1/40 (2.5%)
    Abdominal distension 1/63 (1.6%) 2/59 (3.4%) 0/20 (0%) 0/9 (0%) 3/40 (7.5%) 4/40 (10%)
    Abdominal pain 11/63 (17.5%) 11/59 (18.6%) 2/20 (10%) 0/9 (0%) 4/40 (10%) 3/40 (7.5%)
    Abdominal pain lower 2/63 (3.2%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Abdominal pain upper 1/63 (1.6%) 4/59 (6.8%) 2/20 (10%) 0/9 (0%) 5/40 (12.5%) 4/40 (10%)
    Constipation 18/63 (28.6%) 14/59 (23.7%) 5/20 (25%) 0/9 (0%) 14/40 (35%) 8/40 (20%)
    Diarrhoea 28/63 (44.4%) 25/59 (42.4%) 5/20 (25%) 3/9 (33.3%) 13/40 (32.5%) 14/40 (35%)
    Dry mouth 5/63 (7.9%) 5/59 (8.5%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 1/40 (2.5%)
    Dyspepsia 4/63 (6.3%) 8/59 (13.6%) 3/20 (15%) 0/9 (0%) 5/40 (12.5%) 3/40 (7.5%)
    Dysphagia 1/63 (1.6%) 0/59 (0%) 2/20 (10%) 0/9 (0%) 1/40 (2.5%) 1/40 (2.5%)
    Gastritis 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Gastrointestinal pain 1/63 (1.6%) 0/59 (0%) 2/20 (10%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Gastrooesophageal reflux disease 4/63 (6.3%) 0/59 (0%) 2/20 (10%) 0/9 (0%) 1/40 (2.5%) 1/40 (2.5%)
    Haemorrhoids 2/63 (3.2%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Nausea 20/63 (31.7%) 25/59 (42.4%) 11/20 (55%) 0/9 (0%) 11/40 (27.5%) 14/40 (35%)
    Toothache 0/63 (0%) 2/59 (3.4%) 2/20 (10%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Vomiting 11/63 (17.5%) 13/59 (22%) 3/20 (15%) 0/9 (0%) 8/40 (20%) 5/40 (12.5%)
    General disorders
    Asthenia 11/63 (17.5%) 16/59 (27.1%) 0/20 (0%) 1/9 (11.1%) 3/40 (7.5%) 8/40 (20%)
    Chest pain 4/63 (6.3%) 6/59 (10.2%) 2/20 (10%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Chills 5/63 (7.9%) 4/59 (6.8%) 3/20 (15%) 0/9 (0%) 8/40 (20%) 5/40 (12.5%)
    Fatigue 32/63 (50.8%) 34/59 (57.6%) 13/20 (65%) 5/9 (55.6%) 18/40 (45%) 9/40 (22.5%)
    Feeling hot 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Gait disturbance 1/63 (1.6%) 3/59 (5.1%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 2/40 (5%)
    Influenza like illness 0/63 (0%) 8/59 (13.6%) 0/20 (0%) 1/9 (11.1%) 1/40 (2.5%) 0/40 (0%)
    Malaise 1/63 (1.6%) 2/59 (3.4%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 1/40 (2.5%)
    Nodule 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Oedema peripheral 6/63 (9.5%) 8/59 (13.6%) 3/20 (15%) 0/9 (0%) 2/40 (5%) 3/40 (7.5%)
    Pain 5/63 (7.9%) 1/59 (1.7%) 3/20 (15%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Peripheral swelling 1/63 (1.6%) 2/59 (3.4%) 0/20 (0%) 0/9 (0%) 2/40 (5%) 0/40 (0%)
    Pyrexia 15/63 (23.8%) 9/59 (15.3%) 5/20 (25%) 2/9 (22.2%) 5/40 (12.5%) 3/40 (7.5%)
    Unevaluable event 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Immune system disorders
    Hypogammaglobulinaemia 0/63 (0%) 0/59 (0%) 0/20 (0%) 1/9 (11.1%) 1/40 (2.5%) 0/40 (0%)
    Seasonal allergy 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Infections and infestations
    Candida infection 2/63 (3.2%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 2/40 (5%)
    Ear infection 0/63 (0%) 0/59 (0%) 0/20 (0%) 1/9 (11.1%) 0/40 (0%) 0/40 (0%)
    Gastroenteritis viral 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Herpes zoster 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 2/40 (5%)
    Infection 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Influenza 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Mucosal infection 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Oesophageal candidiasis 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Oral candidiasis 2/63 (3.2%) 2/59 (3.4%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 2/40 (5%)
    Oropharyngeal candidiasis 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Otitis externa 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Pharyngitis 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Pilonidal cyst 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Rash pustular 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Rhinitis 1/63 (1.6%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Sinusitis 0/63 (0%) 1/59 (1.7%) 2/20 (10%) 2/9 (22.2%) 2/40 (5%) 0/40 (0%)
    Tooth infection 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 2/40 (5%)
    Upper respiratory tract infection 5/63 (7.9%) 2/59 (3.4%) 3/20 (15%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Urinary tract infection 6/63 (9.5%) 2/59 (3.4%) 0/20 (0%) 0/9 (0%) 3/40 (7.5%) 1/40 (2.5%)
    Nasopharyngitis 2/63 (3.2%) 1/59 (1.7%) 4/20 (20%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Injury, poisoning and procedural complications
    Animal bite 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Contusion 1/63 (1.6%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 2/40 (5%)
    Fall 1/63 (1.6%) 2/59 (3.4%) 0/20 (0%) 0/9 (0%) 3/40 (7.5%) 2/40 (5%)
    Infusion related reaction 3/63 (4.8%) 1/59 (1.7%) 2/20 (10%) 1/9 (11.1%) 7/40 (17.5%) 3/40 (7.5%)
    Procedural pain 1/63 (1.6%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Radiation skin injury 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Skin Abrasion 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 1/9 (11.1%) 1/40 (2.5%) 0/40 (0%)
    Investigations
    Alanine aminotransferase increased 2/63 (3.2%) 2/59 (3.4%) 0/20 (0%) 1/9 (11.1%) 3/40 (7.5%) 1/40 (2.5%)
    Aspartate aminotransferase increased 2/63 (3.2%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 4/40 (10%) 2/40 (5%)
    Blood creatinine increased 2/63 (3.2%) 1/59 (1.7%) 0/20 (0%) 1/9 (11.1%) 1/40 (2.5%) 1/40 (2.5%)
    Blood potassium decreased 1/63 (1.6%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Lipase increased 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 2/40 (5%) 1/40 (2.5%)
    Neutrophil count decreased 0/63 (0%) 4/59 (6.8%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Platelet count decreased 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 1/9 (11.1%) 0/40 (0%) 2/40 (5%)
    Protein total decreased 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 2/40 (5%) 0/40 (0%)
    Weight decreased 6/63 (9.5%) 7/59 (11.9%) 3/20 (15%) 1/9 (11.1%) 0/40 (0%) 0/40 (0%)
    Weight increased 1/63 (1.6%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    White blood cell count decreased 1/63 (1.6%) 4/59 (6.8%) 0/20 (0%) 1/9 (11.1%) 2/40 (5%) 1/40 (2.5%)
    Metabolism and nutrition disorders
    Decreased appetite 13/63 (20.6%) 17/59 (28.8%) 4/20 (20%) 0/9 (0%) 7/40 (17.5%) 5/40 (12.5%)
    Dehydration 6/63 (9.5%) 3/59 (5.1%) 2/20 (10%) 0/9 (0%) 4/40 (10%) 2/40 (5%)
    Gout 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Hypercalcaemia 1/63 (1.6%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 2/40 (5%) 2/40 (5%)
    Hyperglycaemia 8/63 (12.7%) 4/59 (6.8%) 2/20 (10%) 1/9 (11.1%) 1/40 (2.5%) 4/40 (10%)
    Hyperuricaemia 2/63 (3.2%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 3/40 (7.5%) 1/40 (2.5%)
    Hypokalaemia 7/63 (11.1%) 8/59 (13.6%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 5/40 (12.5%)
    Hypomagnesaemia 5/63 (7.9%) 6/59 (10.2%) 1/20 (5%) 1/9 (11.1%) 1/40 (2.5%) 2/40 (5%)
    Hyponatraemia 1/63 (1.6%) 2/59 (3.4%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Hypophosphataemia 2/63 (3.2%) 3/59 (5.1%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 1/40 (2.5%)
    Type 2 diabetes mellitus 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 9/63 (14.3%) 11/59 (18.6%) 5/20 (25%) 1/9 (11.1%) 4/40 (10%) 3/40 (7.5%)
    Arthritis 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Back pain 7/63 (11.1%) 8/59 (13.6%) 3/20 (15%) 0/9 (0%) 2/40 (5%) 5/40 (12.5%)
    Bone pain 1/63 (1.6%) 6/59 (10.2%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Groin pain 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Joint stiffness 1/63 (1.6%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Muscle spasms 5/63 (7.9%) 6/59 (10.2%) 2/20 (10%) 0/9 (0%) 3/40 (7.5%) 0/40 (0%)
    Muscle tightness 1/63 (1.6%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Muscular weakness 2/63 (3.2%) 6/59 (10.2%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Musculoskeletal chest pain 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 2/40 (5%) 0/40 (0%)
    Musculoskeletal discomfort 0/63 (0%) 0/59 (0%) 2/20 (10%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Musculoskeletal pain 4/63 (6.3%) 5/59 (8.5%) 2/20 (10%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Myalgia 7/63 (11.1%) 6/59 (10.2%) 3/20 (15%) 0/9 (0%) 2/40 (5%) 0/40 (0%)
    Osteopenia 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Pain in extremity 7/63 (11.1%) 12/59 (20.3%) 4/20 (20%) 1/9 (11.1%) 7/40 (17.5%) 6/40 (15%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm of skin 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Squamous cell carcinoma 1/63 (1.6%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Nervous system disorders
    Carpal tunnel syndrome 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Cluster headache 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Cognitive disorder 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Cubital tunnel syndrome 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Dizziness 7/63 (11.1%) 10/59 (16.9%) 3/20 (15%) 0/9 (0%) 6/40 (15%) 4/40 (10%)
    Dysgeusia 2/63 (3.2%) 3/59 (5.1%) 1/20 (5%) 0/9 (0%) 3/40 (7.5%) 0/40 (0%)
    Headache 10/63 (15.9%) 8/59 (13.6%) 6/20 (30%) 1/9 (11.1%) 10/40 (25%) 6/40 (15%)
    Hypoaesthesia 3/63 (4.8%) 2/59 (3.4%) 2/20 (10%) 0/9 (0%) 1/40 (2.5%) 1/40 (2.5%)
    Memory impairment 1/63 (1.6%) 3/59 (5.1%) 2/20 (10%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Nerve compression 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Neuropathy peripheral 23/63 (36.5%) 27/59 (45.8%) 6/20 (30%) 1/9 (11.1%) 8/40 (20%) 8/40 (20%)
    Paraesthesia 5/63 (7.9%) 1/59 (1.7%) 2/20 (10%) 0/9 (0%) 4/40 (10%) 3/40 (7.5%)
    Peripheral motor neuropathy 2/63 (3.2%) 5/59 (8.5%) 1/20 (5%) 0/9 (0%) 4/40 (10%) 0/40 (0%)
    Peripheral sensory neuropathy 16/63 (25.4%) 17/59 (28.8%) 11/20 (55%) 2/9 (22.2%) 7/40 (17.5%) 2/40 (5%)
    Restless legs syndrome 3/63 (4.8%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 3/40 (7.5%) 1/40 (2.5%)
    Syncope 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 1/9 (11.1%) 0/40 (0%) 0/40 (0%)
    Tremor 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 1/40 (2.5%)
    Hepatic Encephalopathy 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Taste Disorder 0/63 (0%) 3/59 (5.1%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 1/40 (2.5%)
    Psychiatric disorders
    Adjustment disorder with depressed mood 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Anxiety 2/63 (3.2%) 5/59 (8.5%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 1/40 (2.5%)
    Depression 3/63 (4.8%) 4/59 (6.8%) 1/20 (5%) 0/9 (0%) 1/40 (2.5%) 1/40 (2.5%)
    Hallucination olfactory 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Insomnia 15/63 (23.8%) 8/59 (13.6%) 3/20 (15%) 1/9 (11.1%) 1/40 (2.5%) 6/40 (15%)
    Renal and urinary disorders
    Dysuria 1/63 (1.6%) 3/59 (5.1%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Nocturia 0/63 (0%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 2/40 (5%) 0/40 (0%)
    Urinary hesitation 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 9/63 (14.3%) 15/59 (25.4%) 3/20 (15%) 1/9 (11.1%) 7/40 (17.5%) 6/40 (15%)
    Dysphonia 1/63 (1.6%) 2/59 (3.4%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 2/40 (5%)
    Dyspnoea 11/63 (17.5%) 11/59 (18.6%) 2/20 (10%) 0/9 (0%) 5/40 (12.5%) 8/40 (20%)
    Dyspnoea exertional 1/63 (1.6%) 0/59 (0%) 2/20 (10%) 0/9 (0%) 1/40 (2.5%) 1/40 (2.5%)
    Epistaxis 3/63 (4.8%) 1/59 (1.7%) 2/20 (10%) 0/9 (0%) 1/40 (2.5%) 2/40 (5%)
    Hiccups 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Hypoxia 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 2/40 (5%) 2/40 (5%)
    Nasal congestion 4/63 (6.3%) 2/59 (3.4%) 2/20 (10%) 1/9 (11.1%) 4/40 (10%) 3/40 (7.5%)
    Oropharyngeal pain 6/63 (9.5%) 0/59 (0%) 3/20 (15%) 1/9 (11.1%) 2/40 (5%) 3/40 (7.5%)
    Orthopnoea 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Pleural effusion 2/63 (3.2%) 0/59 (0%) 2/20 (10%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Productive cough 1/63 (1.6%) 3/59 (5.1%) 4/20 (20%) 2/9 (22.2%) 4/40 (10%) 2/40 (5%)
    Pulmonary congestion 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Rhinitis allergic 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Rhinorrhoea 3/63 (4.8%) 0/59 (0%) 2/20 (10%) 2/9 (22.2%) 1/40 (2.5%) 2/40 (5%)
    Sinus congestion 1/63 (1.6%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Sneezing 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 1/40 (2.5%)
    Bronchiectasis 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Skin and subcutaneous tissue disorders
    Acne 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Actinic keratosis 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Alopecia 10/63 (15.9%) 7/59 (11.9%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 1/40 (2.5%)
    Brow ptosis 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Dermatitis 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Dermatitis acneiform 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Dry skin 3/63 (4.8%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 3/40 (7.5%) 2/40 (5%)
    Erythema 4/63 (6.3%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 3/40 (7.5%) 1/40 (2.5%)
    Hyperhidrosis 2/63 (3.2%) 4/59 (6.8%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 1/40 (2.5%)
    Night sweats 6/63 (9.5%) 4/59 (6.8%) 3/20 (15%) 0/9 (0%) 6/40 (15%) 1/40 (2.5%)
    Pruritus 3/63 (4.8%) 6/59 (10.2%) 2/20 (10%) 0/9 (0%) 7/40 (17.5%) 3/40 (7.5%)
    Rash erythematous 0/63 (0%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Rash pruritic 2/63 (3.2%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 1/40 (2.5%) 0/40 (0%)
    Rash 3/63 (4.8%) 3/59 (5.1%) 0/20 (0%) 0/9 (0%) 1/40 (2.5%) 1/40 (2.5%)
    Surgical and medical procedures
    Thrombolysis 0/63 (0%) 0/59 (0%) 0/20 (0%) 1/9 (11.1%) 0/40 (0%) 0/40 (0%)
    Vascular disorders
    Flushing 1/63 (1.6%) 0/59 (0%) 0/20 (0%) 0/9 (0%) 4/40 (10%) 1/40 (2.5%)
    Haematoma 0/63 (0%) 1/59 (1.7%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 2/40 (5%)
    Hypertension 0/63 (0%) 3/59 (5.1%) 0/20 (0%) 0/9 (0%) 0/40 (0%) 0/40 (0%)
    Hypotension 4/63 (6.3%) 1/59 (1.7%) 1/20 (5%) 0/9 (0%) 2/40 (5%) 4/40 (10%)
    Orthostatic hypotension 0/63 (0%) 0/59 (0%) 1/20 (5%) 0/9 (0%) 0/40 (0%) 0/40 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

    Results Point of Contact

    Name/Title Medical Communications
    Organization Hoffmann-La Roche
    Phone 800-821-8590
    Email genentech@druginfo.com
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT01691898
    Other Study ID Numbers:
    • GO27834
    • 2011-004377-84
    First Posted:
    Sep 25, 2012
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020