Phase II Study of Ofatumumab Plus Ifosfamide, Carboplatin, Etoposide (ICE) or Dexamethasone, Cytarabine, Cisplatin (DHAP) Chemotherapy Regimen in Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00823719

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in combination with ifosfamide, carboplatin, etoposide (ICE) or dexamethasone, cytarabine, cisplatin (DHAP) salvage chemotherapy regimens in subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are eligible for autologous stem cell transplant.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Large-Cell, Diffuse	Drug: ofatumumab + ICE Drug: ofatumumab + DHAP	Phase 2

Detailed Description

Rituximab combined with anthracycline based chemotherapy is the most common first-line treatment for subjects with diffuse large B cell lymphoma (DLBCL). Subjects requiring second-line therapy will most often receive rituximab in combination with salvage chemotherapy as an induction therapy prior to autologous stem cell transplant. With rituximab being in first-line therapy, the response rates for subjects receiving rituximab plus salvage chemotherapy has significantly decreased. Treatment with ofatumumab may be able to overcome the resistance to rituximab in the second-line setting and offer improved response rates. The objective of this study is to evaluate the overall response rate of ofatumumab in combination with ICE or DHAP chemotherapy prior to autologous stem cell transplant. Additional objectives are to evaluate the complete response rate, ability to mobilize cluster of differentiation (CD)34+ cells, progression-free survival (PFS) and overall survival.

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single Arm, Safety and Efficacy Study of Ofatumumab in Combination With ICE or DHAP Chemotherapy in Relapsed or Refractory Aggressive Lymphoma Prior to Autologous Stem Cell Transplantation

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ofatumumab + DHAP or ICE chemotherapy regimen This study is a single arm study, but the Investigators are required to prospectively choose to treat all of their subjects with either ICE or DHAP chemotherapy regimens in combination with ofatumumab. Regardless of whether the subject receives ICE or DHAP chemotherapy, all subjects will receive the same ofatumumab regimen and dose.	Drug: ofatumumab + ICE 3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 milligrams (mg); cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg ICE regimen: ifosfamide + mesna - 5 grams (g)/meters squared (m^2)/24 hours (hrs) continuous on day 2 of dosing cycle; carboplatin - AUC 5 (800 mg maximum) on day 2 of dosing cycle; etoposide - 100 mg/m^2 on days 1, 2 and 3 of dosing cycle. Drug: ofatumumab + DHAP 3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 mg; cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m^2/24 hrs continuous on day 1 of dosing cycle; cytarabine - 2 g/m^2 q12 hrs (2 doses) on day 2 of dosing cycle.

Arm

Intervention/Treatment

Experimental: ofatumumab + DHAP or ICE chemotherapy regimen

This study is a single arm study, but the Investigators are required to prospectively choose to treat all of their subjects with either ICE or DHAP chemotherapy regimens in combination with ofatumumab. Regardless of whether the subject receives ICE or DHAP chemotherapy, all subjects will receive the same ofatumumab regimen and dose.

Drug: ofatumumab + ICE

3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 milligrams (mg); cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg ICE regimen: ifosfamide + mesna - 5 grams (g)/meters squared (m^2)/24 hours (hrs) continuous on day 2 of dosing cycle; carboplatin - AUC 5 (800 mg maximum) on day 2 of dosing cycle; etoposide - 100 mg/m^2 on days 1, 2 and 3 of dosing cycle.

Drug: ofatumumab + DHAP

3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 mg; cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m^2/24 hrs continuous on day 1 of dosing cycle; cytarabine - 2 g/m^2 q12 hrs (2 doses) on day 2 of dosing cycle.

Outcome Measures

Primary Outcome Measures

Number of Participants With Overall Response (OR), as Assessed by the Investigator [From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3]
Responders with OR included participants with complete response (CR) and partial response (PR). This was based on adequate responses from the investigator assessment after the completion of treatment. CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease from baseline in the sum of the product of the diameters of target lesions.

Secondary Outcome Measures

Number of Participants With CR, as Assessed by the Investigator [From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3]
CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.
Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram (kg) From Peripheral Blood [During treatment Cycle 2 (Study Days 22-42) and/or Cycle 3 (Study Days 43-63)]
CD34+ cells are a mixture of stem cells and white blood cells of various degrees of maturity. Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization was defined as the collection of >2x10^6 CD34+ cells/kg. Only those participants, who commenced mobilization, following the administration of ofatumumab in combination with either ICE or DHAP combination chemotherapy, were assessed.
Progression-free Survival (PFS) [From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3]
PFS is defined as the interval of time between the date of treatment start and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments locally by investigators for the disease under study. Disease progression was based on imaging data or clinical assessment data (if radiologic assessment data were not possible or assessment was not performed).
Overall Survival [From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3]
Overall survival is defined as the interval of time between the date of treatment start and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.
Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf), of Ofatumumab at the First Infusion (Cycle 1, Day 1) and the Last Infusion (Cycle 3) [Cycle 1 Day 1 (Study Day 1; up to 1 week) and Cycle 3 (Study Day 43; up to 6 weeks)]
AUC is defined as the area under the ofatumumab (Ofa) concentration-time curve as a measure of drug exposure. AUC(0-inf) is AUC from the start of infusion extrapolated to infinite time. Results are reported by first dose group and combined, as appropriate.
Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) of Ofatumumab at the Last Infusion (Cycle 3) [Cycle 3 (Study Day 43; 3 weeks)]
AUC(0-tau) is the area under the plasma concentration-time curve from time zero (0) over the dosing interval, tau, and is a measure of drug exposure. Tau is 21 days (504 hours) in this study.
Clearance (CL) of Ofatumumab [Study Day 1 up to Study Day 85 (up to 12 weeks)]
CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.
Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3) [Cycle 1 Day 1 (Study Day 1; up to 48 hours), Cycle 1 Day 8 (Study Day 8; up to 24 hours), Cycle 3 (Study Day 43; up to 48 hours)]
Cmax is defined as the maximum concentration of drug in plasma samples for the dosing occasion.
Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3) [Cycle 1 Day 8 (Study Day 8; up to 8 hours prior to infusion start), Cycle 2 (Study Day 22; up to 7 hours prior to infusion start), Cycle 3 (Study Day 43; up to 6 hours prior to infusion start)]
Ctrough is defined as the trough plasma concentration, which is the measured concentration at the end of a dosing interval (taken directly before the start of the next infusion).
Terminal Phase Half-life (t1/2) of Ofatumumab [Study Day 1 up to Study Day 85 (up to 12 weeks)]
t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half.
Volume of Distribution at Steady State (Vss) of Ofatumumab [Study Day 1 up to Study Day 85 (up to 12 weeks)]
Vss is the apparent volume of distribution when plasma concentrations are measured under steady state conditions. At steady state, the plasma concentration-time profile of the drug is similar after each dose.
Number of Participants Who Were Positive and Negative for Human Anti-human Antibodies (HAHA) at the Indicated Time Points [Study Day 1 up to approximately Study Day 63]
Human anti-human antibodies (HAHA) indicate immune response to the administered human monoclonal antibody in a two-step assay. A positive screening result is confirmed in a second step. Negative Conclusive is subset of Negative and is a negative HAHA test result with an ofatumumab concentration <200 µg/mL in a pharmacokinetic sample collected at the same time as the HAHA sample. Data are presented when a HAHA sample was collected. WD, withdrawal; FU, follow up.
Number of Participants With the Indicated Adverse Events (AEs) Associated With Neutropenia [Study Day 1 to approximately Study Day 63]
Neutropenia is defined as an abnormal decrease in the number of neutrophils (type of white blood cell in blood) in the blood. Febrile neutropenia is the development of fever in participants with neutropenia. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.
Number of Participants With the Indicated AEs Associated With Decreased Hemoglobin Counts [Study Day 1 to approximately Study Day 63]
Anaemia is defined as a pathological deficiency in the oxygen-carrying component of the blood, measured in unit volume concentrations of hemoglobin, red blood-cell volume, or red blood-cell number. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.
Number of Participants With the Indicated AEs Associated With Decreased Platelet Counts [Study Day 1 to approximately Study Day 63]
Thrombocytopenia is defined as an abnormal decrease in the number of platelets in circulatory blood. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects with CD20 positive aggressive non-Hodgkin's lymphoma (NHL) including DLBCL, transformed follicular lymphoma (FL) & grade 3b FL.

Refractory to, or relapsed following, first-line treatment with rituximab combined with anthracycline- or anthracenedione-based chemotherapy as defined by the protocol.

Computed tomography (CT) with involvement of 2 or more clearly demarcated lesions with a long axis > 1.5 centimeters (cm) and short axis ≥ 1.0 cm or 1 clearly demarcated lesion with a long axis >2.0 cm and short axis ≥1.0 cm.
Baseline [18F] fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans must demonstrate positive lesions compatible with CT defined anatomical tumor sites.
Age 18 yrs or older.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Eligible for high dose chemotherapy and autologous stem cell transplant (ASCT).
Resolution of toxicities from first-line therapy to a grade that in the opinion of the investigator does not contraindicate study participation.
Signed written informed consent.

Exclusion Criteria:

Previous cancer therapy for lymphoma, with the exception of required rituximab/ anthracycline- or anthracenedione-based chemotherapy, monotherapy rituximab prior to first-line therapy and / or as a maintenance therapy, or limited field radiotherapy (as defined by the protocol).
Any anti-cancer therapy, except limited field radiotherapy, within 2 weeks prior to start of study therapy.
Chronic Glucocorticoid use (limited acute use is allowed and defined by the protocol).
History of significant cerebrovascular disease.
Abnormal/ inadequate white blood cell (WBC) count, liver, and kidney function.
Clinically significant cardiac disease, active or chronic infections, serious significant diseases, other cancer within last 5 years.
Known or suspected hypersensitivity to study treatments.
Prior treatment with anti-CD20 monoclonal antibodies, at any time, or treated with other monoclonal antibodies within 3 months prior to start of study therapy, with the exception of rituximab in both instances.
Inability to comply with the protocol activities.
Pregnant or lactating women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception during and up to 1 year following dosing completion.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00823719

Other Study ID Numbers:

110927

First Posted:

Jan 16, 2009

Last Update Posted:

Mar 12, 2013

Last Verified:

Feb 1, 2013

Keywords provided by GlaxoSmithKline

Salvage chemotherapy

relapsed

grade 3B follicular lymphoma

Non-Hodgkin's Lymphoma

Diffuse Large B Cell Lymphoma (DLBCL)

Oncology

ICE

Transformed follicular lymphoma

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Ofatumumab

Antibodies, Monoclonal

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Period Title: Overall Study
STARTED	26	35
COMPLETED	20	24
NOT COMPLETED	6	11

Baseline Characteristics

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Total of all reporting groups
Overall Participants	26	35	61
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.7 (13.79)	53.0 (13.02)	51.6 (13.34)
Sex: Female, Male (Count of Participants)
Female	11 42.3%	15 42.9%	26 42.6%
Male	15 57.7%	20 57.1%	35 57.4%
Race/Ethnicity, Customized (participants) [Number]
African American/African Heritage	2 7.7%	2 5.7%	4 6.6%
Asian-Central/South Asian Heritage	1 3.8%	0 0%	1 1.6%
Asian-Japanese/East or South East Asian Heritage	1 3.8%	0 0%	1 1.6%
White	22 84.6%	33 94.3%	55 90.2%
Number of participants with the indicated number of risk factors (participants) [Number]
0 or 1	13 50%	19 54.3%	32 52.5%
2 or 3	13 50%	16 45.7%	29 47.5%
Number of participants in the indicated categories per best response to first line treatment (participants) [Number]
Late relapsers	4 15.4%	8 22.9%	12 19.7%
Early relapsers/Refractory	22 84.6%	27 77.1%	49 80.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Overall Response (OR), as Assessed by the Investigator
Description	Responders with OR included participants with complete response (CR) and partial response (PR). This was based on adequate responses from the investigator assessment after the completion of treatment. CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease from baseline in the sum of the product of the diameters of target lesions.
Time Frame	From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3

Outcome Measure Data

Analysis Population Description
Per protocol (PP) Population: all participants who received at least one dose of ofatumumab. Participants with major protocol deviations that could have impacted the efficacy outcome, and participants not exposed to ofatumumab or without CD20+ aggressive lymphoma were excluded from assessment. CD, cluster of differentiation.

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	33	59
Number [participants]	18 69.2%	18 51.4%	36 59%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ofatumumab + DHAP
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	69
	Confidence Interval	(2-Sided) 95% 48.2 to 85.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + DHAP treatment.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ofatumumab + ICE
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	55
	Confidence Interval	(2-Sided) 95% 36.4 to 71.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + ICE treatment.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Total Ofatumumab + Chemotherapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	61
	Confidence Interval	(2-Sided) 95% 47.4 to 73.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value represents the percentage of participants with OR for participants receiving Total Ofatumumab + Chemotherapy treatment.

2. Secondary Outcome

Title	Number of Participants With CR, as Assessed by the Investigator
Description	CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.
Time Frame	From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3

Outcome Measure Data

Analysis Population Description
PP Population

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	33	59
Number [participants]	11 42.3%	11 31.4%	22 36.1%

3. Secondary Outcome

Title	Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram (kg) From Peripheral Blood
Description	CD34+ cells are a mixture of stem cells and white blood cells of various degrees of maturity. Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization was defined as the collection of >2x10^6 CD34+ cells/kg. Only those participants, who commenced mobilization, following the administration of ofatumumab in combination with either ICE or DHAP combination chemotherapy, were assessed.
Time Frame	During treatment Cycle 2 (Study Days 22-42) and/or Cycle 3 (Study Days 43-63)

Outcome Measure Data

Analysis Population Description
Stem Cell Mobilization Population. All participants in the PP Population in whom stem cell mobilization was attempted and CD34+ cell data are available.

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	23	22	45
Number [participants]	23 88.5%	20 57.1%	43 70.5%

4. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	PFS is defined as the interval of time between the date of treatment start and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments locally by investigators for the disease under study. Disease progression was based on imaging data or clinical assessment data (if radiologic assessment data were not possible or assessment was not performed).
Time Frame	From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3

Outcome Measure Data

Analysis Population Description
PP Population

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	33	59
Median (95% Confidence Interval) [days]	301.0	288.0	288.0

5. Secondary Outcome

Title	Overall Survival
Description	Overall survival is defined as the interval of time between the date of treatment start and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.
Time Frame	From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3

Outcome Measure Data

Analysis Population Description
PP Population

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	33	59
Median (95% Confidence Interval) [days]	433.0	NA	508.0

6. Secondary Outcome

Title	Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf), of Ofatumumab at the First Infusion (Cycle 1, Day 1) and the Last Infusion (Cycle 3)
Description	AUC is defined as the area under the ofatumumab (Ofa) concentration-time curve as a measure of drug exposure. AUC(0-inf) is AUC from the start of infusion extrapolated to infinite time. Results are reported by first dose group and combined, as appropriate.
Time Frame	Cycle 1 Day 1 (Study Day 1; up to 1 week) and Cycle 3 (Study Day 43; up to 6 weeks)

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population: all participants (par.) exposed to ofatumumab from whom a pharmacokinetic sample was obtained and analyzed. Data for par. who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the par. attending each visit.

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	35	61
Cycle 1 Day 1, 300 mg; n=4, 17, 21	34056 (0.14)	33606 (0.15)	33691 (0.14)
Cycle 1 Day 1, 1000 mg; n=22, 18, 40	115741 (0.16)	105898 (0.14)	111203 (0.16)
Cycle 3, 300 mg; n=4, 6, 10	222713 (0.23)	206389 (0.06)	212770 (0.14)
Cycle 3, 1000 mg; n=14, 13, 30	258487 (0.21)	216885 (0.17)	232310 (0.21)
Cycle 3, both doses; n=18, 19, 40	250070 (0.22)	213514 (0.14)	227263 (0.20)

7. Secondary Outcome

Title	Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) of Ofatumumab at the Last Infusion (Cycle 3)
Description	AUC(0-tau) is the area under the plasma concentration-time curve from time zero (0) over the dosing interval, tau, and is a measure of drug exposure. Tau is 21 days (504 hours) in this study.
Time Frame	Cycle 3 (Study Day 43; 3 weeks)

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	35	61
Cycle 3, 300 mg; n=4, 6, 10	95112 (0.09)	83385 (0.33)	87891 (0.26)
Cycle 3, 1000 mg; n=14, 13, 30	112676 (0.22)	95341 (0.15)	101948 (0.21)
Cycle 3 both doses; n=18, 19, 40	108511 (0.21)	91391 (0.22)	98236 (0.23)

8. Secondary Outcome

Title	Clearance (CL) of Ofatumumab
Description	CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.
Time Frame	Study Day 1 up to Study Day 85 (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	35	61
Geometric Mean (Geometric Coefficient of Variation) [mL/hr]	8.7 (0.15)	9.2 (0.14)	9.0 (0.15)

9. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3)
Description	Cmax is defined as the maximum concentration of drug in plasma samples for the dosing occasion.
Time Frame	Cycle 1 Day 1 (Study Day 1; up to 48 hours), Cycle 1 Day 8 (Study Day 8; up to 24 hours), Cycle 3 (Study Day 43; up to 48 hours)

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	35	61
Cycle 1 Day 1, 300 mg; n=4, 17, 21	89.8 (0.08)	80.0 (0.63)	81.8 (0.56)
Cycle 1 Day 1, 1000 mg; n=22, 18, 40	323 (0.40)	268 (0.30)	297 (0.37)
Cycle 1 Day 8, 300 mg; n=4, 13, 17	245 (0.10)	273 (0.28)	266 (0.25)
Cycle 1 Day 8, 1000 mg; n=21, 18, 39	431 (0.23)	368 (0.21)	401 (0.23)
Cycle 3, 300 mg; n=4, 11, 15	416 (0.24)	417 (0.26)	417 (0.24)
Cycle 3, 1000 mg; n=14, 14, 33	466 (0.31)	397 (0.18)	421 (0.25)
Cycle 3, both doses; n=18, 25, 48	455 (0.29)	406 (0.21)	420 (0.25)

10. Secondary Outcome

Title	Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3)
Description	Ctrough is defined as the trough plasma concentration, which is the measured concentration at the end of a dosing interval (taken directly before the start of the next infusion).
Time Frame	Cycle 1 Day 8 (Study Day 8; up to 8 hours prior to infusion start), Cycle 2 (Study Day 22; up to 7 hours prior to infusion start), Cycle 3 (Study Day 43; up to 6 hours prior to infusion start)

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	35	61
Cycle 1 Day 8, 300 mg; n=4, 15, 19	31.8 (0.19)	28.3 (0.93)	29.1 (0.79)
Cycle 1 Day 8, 1000 mg; n=19, 18, 37	95.8 (1.63)	106 (0.23)	101 (0.98)
Cycle 2, 300 mg; n=4, 16, 20	112 (0.28)	71.5 (0.81)	78.2 (0.75)
Cycle 2, 1000 mg; n=21, 18, 39	138 (0.49)	147 (0.21)	142 (0.38)
Cycle 3, 300 mg; n=4, 13, 17	120 (0.26)	76.7 (0.65)	85.2 (0.60)
Cycle 3, 1000 mg; n=18, 18, 40	153 (0.43)	122 (0.45)	134 (0.44)
Cycle 3, both doses; n=22, 31, 57	146 (0.41)	100 (0.59)	117 (0.54)

11. Secondary Outcome

Title	Terminal Phase Half-life (t1/2) of Ofatumumab
Description	t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half.
Time Frame	Study Day 1 up to Study Day 85 (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	35	61
Geometric Mean (Geometric Coefficient of Variation) [hr]	595 (0.35)	646 (0.47)	624 (0.42)

12. Secondary Outcome

Title	Volume of Distribution at Steady State (Vss) of Ofatumumab
Description	Vss is the apparent volume of distribution when plasma concentrations are measured under steady state conditions. At steady state, the plasma concentration-time profile of the drug is similar after each dose.
Time Frame	Study Day 1 up to Study Day 85 (up to 12 weeks)

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	35	61
Geometric Mean (Geometric Coefficient of Variation) [Liters]	7.12 (0.38)	8.13 (0.50)	7.68 (0.46)

13. Secondary Outcome

Title	Number of Participants Who Were Positive and Negative for Human Anti-human Antibodies (HAHA) at the Indicated Time Points
Description	Human anti-human antibodies (HAHA) indicate immune response to the administered human monoclonal antibody in a two-step assay. A positive screening result is confirmed in a second step. Negative Conclusive is subset of Negative and is a negative HAHA test result with an ofatumumab concentration <200 µg/mL in a pharmacokinetic sample collected at the same time as the HAHA sample. Data are presented when a HAHA sample was collected. WD, withdrawal; FU, follow up.
Time Frame	Study Day 1 up to approximately Study Day 63

Outcome Measure Data

Analysis Population Description
Safety Population. Data are presented for those participants who contributed a sample.

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	35	61
Positive at Day 1; n=26, 35, 61	0 0%	0 0%	0 0%
Negative at Day 1; n=26, 35, 61	26 100%	35 100%	61 100%
Positive at Early WD or FU; n=24, 30, 54	0 0%	0 0%	0 0%
Negative at Early WD or FU; n=24, 30, 54	24 92.3%	30 85.7%	54 88.5%
Negative conclusive at Early WD or FU; n=24, 30, 5	18 69.2%	28 80%	46 75.4%

14. Secondary Outcome

Title	Number of Participants With the Indicated Adverse Events (AEs) Associated With Neutropenia
Description	Neutropenia is defined as an abnormal decrease in the number of neutrophils (type of white blood cell in blood) in the blood. Febrile neutropenia is the development of fever in participants with neutropenia. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.
Time Frame	Study Day 1 to approximately Study Day 63

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	35	61
Any Event of Decreased Neutrophils; n=26, 35, 61	12 46.2%	11 31.4%	23 37.7%
Neutropenia; n=12, 11, 23	7 26.9%	11 31.4%	18 29.5%
Febrile Neutropenia; n=12, 11, 23	8 30.8%	1 2.9%	9 14.8%
Pancytopenia; n=12, 11, 23	1 3.8%	0 0%	1 1.6%

15. Secondary Outcome

Title	Number of Participants With the Indicated AEs Associated With Decreased Hemoglobin Counts
Description	Anaemia is defined as a pathological deficiency in the oxygen-carrying component of the blood, measured in unit volume concentrations of hemoglobin, red blood-cell volume, or red blood-cell number. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.
Time Frame	Study Day 1 to approximately Study Day 63

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	35	61
Any Event of Decreased Hemoglobin; n=26, 35, 61	16 61.5%	18 51.4%	34 55.7%
Anaemia; n=16, 18, 34	14 53.8%	16 45.7%	30 49.2%
Haemoglobin Decreased; n=16, 18, 34	3 11.5%	2 5.7%	5 8.2%
Pancytopenia; n=16, 18, 34	1 3.8%	0 0%	1 1.6%

16. Secondary Outcome

Title	Number of Participants With the Indicated AEs Associated With Decreased Platelet Counts
Description	Thrombocytopenia is defined as an abnormal decrease in the number of platelets in circulatory blood. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.
Time Frame	Study Day 1 to approximately Study Day 63

Outcome Measure Data

Analysis Population Description
Safety Population

Arm/Group Title	Ofatumumab + DHAP	Ofatumumab + ICE	Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
Measure Participants	26	35	61
Any Event of Decreased Platelets; n=26, 35, 61	21 80.8%	19 54.3%	40 65.6%
Thrombocytopenia; n=21, 19, 40	20 76.9%	19 54.3%	39 63.9%
Pancytopenia; n=21, 19, 40	1 3.8%	0 0%	1 1.6%

Adverse Events

	Ofatumumab + DHAP		Ofatumumab + ICE		Total Ofatumumab + Chemotherapy
Time Frame	Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Adverse Event Reporting Description

Arm/Group Title	Ofatumumab + DHAP		Ofatumumab + ICE		Total Ofatumumab + Chemotherapy
Arm/Group Description	Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.		Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.		Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Ofatumumab + DHAP		Ofatumumab + ICE		Total Ofatumumab + Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/26 (65.4%)		7/35 (20%)		24/61 (39.3%)
Blood and lymphatic system disorders
Febrile neutropenia	8/26 (30.8%)		1/35 (2.9%)		9/61 (14.8%)
Thrombocytopenia	7/26 (26.9%)		2/35 (5.7%)		9/61 (14.8%)
Anaemia	2/26 (7.7%)		1/35 (2.9%)		3/61 (4.9%)
Cardiac disorders
Arrhythmia supraventricular	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Ear and labyrinth disorders
Tinnitus	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Eye disorders
Vision blurred	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Gastrointestinal disorders
Nausea	2/26 (7.7%)		0/35 (0%)		2/61 (3.3%)
Vomiting	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Caecitis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
General disorders
Fatigue	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Pyrexia	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Immune system disorders
Hypersensitivity	2/26 (7.7%)		0/35 (0%)		2/61 (3.3%)
Infections and infestations
Cellulitis	2/26 (7.7%)		0/35 (0%)		2/61 (3.3%)
Clostridium difficile colitis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Device related sepsis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Parainfluenzae virus infection	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Pneumonia	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Urinary tract infection staphylococcal	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Investigations
Haemoglobin decreased	3/26 (11.5%)		0/35 (0%)		3/61 (4.9%)
Blood creatinine increased	2/26 (7.7%)		0/35 (0%)		2/61 (3.3%)
Blood creatinine	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Metabolism and nutrition disorders
Hypokalaemia	2/26 (7.7%)		0/35 (0%)		2/61 (3.3%)
Dehydration	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Failure to thrive	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Tumour lysis syndrome	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Musculoskeletal and connective tissue disorders
Muscular weakness	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Nervous system disorders
Ataxia	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Dyskinesia	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Syncope	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Toxic encephalopathy	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Psychiatric disorders
Mental status changes	0/26 (0%)		2/35 (5.7%)		2/61 (3.3%)
Renal and urinary disorders
Renal failure	2/26 (7.7%)		1/35 (2.9%)		3/61 (4.9%)
Renal failure acute	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Pleural effusion	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Pulmonary embolism	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Respiratory distress	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Respiratory failure	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Vascular disorders
Hypotension	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Other (Not Including Serious) Adverse Events
	Ofatumumab + DHAP		Ofatumumab + ICE		Total Ofatumumab + Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/26 (100%)		35/35 (100%)		61/61 (100%)
Blood and lymphatic system disorders
Thrombocytopenia	16/26 (61.5%)		18/35 (51.4%)		34/61 (55.7%)
Anaemia	12/26 (46.2%)		15/35 (42.9%)		27/61 (44.3%)
Neutropenia	7/26 (26.9%)		11/35 (31.4%)		18/61 (29.5%)
Lymphopenia	0/26 (0%)		15/35 (42.9%)		15/61 (24.6%)
Leukopenia	0/26 (0%)		13/35 (37.1%)		13/61 (21.3%)
Leukocytosis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Pancytopenia	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Cardiac disorders
Aortic valve incompetence	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Bradycardia	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Cardiac failure congestive	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Sinus tachycardia	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Ventricular extrasystoles	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Ear and labyrinth disorders
Tinnitus	5/26 (19.2%)		0/35 (0%)		5/61 (8.2%)
Ear pruritus	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Eye disorders
Vision blurred	2/26 (7.7%)		2/35 (5.7%)		4/61 (6.6%)
Lacrimation increased	0/26 (0%)		3/35 (8.6%)		3/61 (4.9%)
Dry eye	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Blindness transient	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Eye pain	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Eye pruritus	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Ocular hyperaemia	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Periorbital oedema	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Visual impairment	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Gastrointestinal disorders
Nausea	22/26 (84.6%)		25/35 (71.4%)		47/61 (77%)
Vomiting	9/26 (34.6%)		15/35 (42.9%)		24/61 (39.3%)
Constipation	9/26 (34.6%)		11/35 (31.4%)		20/61 (32.8%)
Diarrhoea	8/26 (30.8%)		12/35 (34.3%)		20/61 (32.8%)
Abdominal distension	4/26 (15.4%)		2/35 (5.7%)		6/61 (9.8%)
Dyspepsia	2/26 (7.7%)		2/35 (5.7%)		4/61 (6.6%)
Flatulence	3/26 (11.5%)		0/35 (0%)		3/61 (4.9%)
Oral pain	0/26 (0%)		3/35 (8.6%)		3/61 (4.9%)
Abdominal pain	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Dysphagia	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Gastritis	0/26 (0%)		2/35 (5.7%)		2/61 (3.3%)
Stomatitis	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Toothache	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Anal fissure	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Anorectal discomfort	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Duodenal ulcer	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Gastrooesophageal reflux disease	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Haematochezia	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Hypoaesthesia oral	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Lip dry	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
General disorders
Fatigue	20/26 (76.9%)		18/35 (51.4%)		38/61 (62.3%)
Oedema peripheral	2/26 (7.7%)		8/35 (22.9%)		10/61 (16.4%)
Oedema	4/26 (15.4%)		1/35 (2.9%)		5/61 (8.2%)
Pain	5/26 (19.2%)		0/35 (0%)		5/61 (8.2%)
Chest pain	3/26 (11.5%)		1/35 (2.9%)		4/61 (6.6%)
Asthenia	3/26 (11.5%)		0/35 (0%)		3/61 (4.9%)
Chest discomfort	2/26 (7.7%)		1/35 (2.9%)		3/61 (4.9%)
Pyrexia	2/26 (7.7%)		1/35 (2.9%)		3/61 (4.9%)
Chills	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Discomfort	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Feeling jittery	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Generalised oedema	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Local swelling	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Mucosal inflammation	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Sensation of foreign body	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Hepatobiliary disorders
Hyperbilirubinaemia	0/26 (0%)		2/35 (5.7%)		2/61 (3.3%)
Portal vein thrombosis	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Immune system disorders
Hypersensitivity	1/26 (3.8%)		4/35 (11.4%)		5/61 (8.2%)
Drug hypersensitivity	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Infections and infestations
Upper respiratory tract infection	2/26 (7.7%)		1/35 (2.9%)		3/61 (4.9%)
Urinary tract infection	1/26 (3.8%)		2/35 (5.7%)		3/61 (4.9%)
Bacteraemia	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Bartholin's abscess	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Bronchitis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Candidiasis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Cellulitis	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Eye infection	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Folliculitis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Oral candidiasis	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Oral herpes	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Pneumonia	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Sepsis syndrome	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Tooth abscess	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Vulval abscess	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Injury, poisoning and procedural complications
Infusion related reaction	0/26 (0%)		3/35 (8.6%)		3/61 (4.9%)
Contusion	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Laceration	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Procedural pain	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Transfusion reaction	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Investigations
Blood creatinine increased	9/26 (34.6%)		3/35 (8.6%)		12/61 (19.7%)
Aspartate aminotransferase increased	0/26 (0%)		9/35 (25.7%)		9/61 (14.8%)
Blood alkaline phosphatase increased	0/26 (0%)		9/35 (25.7%)		9/61 (14.8%)
Blood lactate dehydrogenase increased	0/26 (0%)		8/35 (22.9%)		8/61 (13.1%)
Alanine aminotransferase increased	0/26 (0%)		7/35 (20%)		7/61 (11.5%)
Weight increased	6/26 (23.1%)		0/35 (0%)		6/61 (9.8%)
Haemoglobin decreased	0/26 (0%)		2/35 (5.7%)		2/61 (3.3%)
Blood pressure increased	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Blood uric acid increased	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Brain natriuretic peptide increased	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Heart rate irregular	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Metabolism and nutrition disorders
Hypomagnesaemia	11/26 (42.3%)		13/35 (37.1%)		24/61 (39.3%)
Hypokalaemia	5/26 (19.2%)		14/35 (40%)		19/61 (31.1%)
Hyperglycaemia	2/26 (7.7%)		9/35 (25.7%)		11/61 (18%)
Hypocalcaemia	3/26 (11.5%)		8/35 (22.9%)		11/61 (18%)
Hypophosphataemia	0/26 (0%)		10/35 (28.6%)		10/61 (16.4%)
Hypoalbuminaemia	1/26 (3.8%)		6/35 (17.1%)		7/61 (11.5%)
Decreased appetite	1/26 (3.8%)		5/35 (14.3%)		6/61 (9.8%)
Hyponatraemia	1/26 (3.8%)		4/35 (11.4%)		5/61 (8.2%)
Dehydration	4/26 (15.4%)		0/35 (0%)		4/61 (6.6%)
Hypercalcaemia	1/26 (3.8%)		2/35 (5.7%)		3/61 (4.9%)
Hyperuricaemia	2/26 (7.7%)		1/35 (2.9%)		3/61 (4.9%)
Fluid overload	2/26 (7.7%)		0/35 (0%)		2/61 (3.3%)
Hyperkalaemia	2/26 (7.7%)		0/35 (0%)		2/61 (3.3%)
Hyperphosphataemia	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Gout	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Hypoglycaemia	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Musculoskeletal and connective tissue disorders
Myalgia	1/26 (3.8%)		9/35 (25.7%)		10/61 (16.4%)
Back pain	3/26 (11.5%)		2/35 (5.7%)		5/61 (8.2%)
Bone pain	4/26 (15.4%)		0/35 (0%)		4/61 (6.6%)
Arthralgia	1/26 (3.8%)		2/35 (5.7%)		3/61 (4.9%)
Muscle spasms	0/26 (0%)		2/35 (5.7%)		2/61 (3.3%)
Musculoskeletal chest pain	0/26 (0%)		2/35 (5.7%)		2/61 (3.3%)
Pain in extremity	0/26 (0%)		2/35 (5.7%)		2/61 (3.3%)
Musculoskeletal pain	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Pain in jaw	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Pruritus	2/26 (7.7%)		4/35 (11.4%)		6/61 (9.8%)
Nervous system disorders
Headache	9/26 (34.6%)		6/35 (17.1%)		15/61 (24.6%)
Dizziness	4/26 (15.4%)		8/35 (22.9%)		12/61 (19.7%)
Hypoaesthesia	3/26 (11.5%)		6/35 (17.1%)		9/61 (14.8%)
Dysgeusia	4/26 (15.4%)		2/35 (5.7%)		6/61 (9.8%)
Paraesthesia	1/26 (3.8%)		5/35 (14.3%)		6/61 (9.8%)
Memory impairment	0/26 (0%)		4/35 (11.4%)		4/61 (6.6%)
Syncope	2/26 (7.7%)		1/35 (2.9%)		3/61 (4.9%)
Lethargy	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Neuropathy peripheral	2/26 (7.7%)		0/35 (0%)		2/61 (3.3%)
Burning sensation	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Neurotoxicity	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Peripheral sensory neuropathy	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Sciatica	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Psychiatric disorders
Insomnia	4/26 (15.4%)		5/35 (14.3%)		9/61 (14.8%)
Anxiety	0/26 (0%)		3/35 (8.6%)		3/61 (4.9%)
Confusional state	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Depression	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Hallucination, visual	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Tearfulness	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Renal and urinary disorders
Renal impairment	2/26 (7.7%)		0/35 (0%)		2/61 (3.3%)
Haematuria	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Hydronephrosis	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Proteinuria	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Renal failure acute	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Reproductive system and breast disorders
Breast mass	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Scrotal oedema	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Vaginal haemorrhage	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	8/26 (30.8%)		10/35 (28.6%)		18/61 (29.5%)
Cough	5/26 (19.2%)		3/35 (8.6%)		8/61 (13.1%)
Hiccups	4/26 (15.4%)		2/35 (5.7%)		6/61 (9.8%)
Epistaxis	2/26 (7.7%)		3/35 (8.6%)		5/61 (8.2%)
Acute pulmonary oedema	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Dysphonia	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Haemoptysis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Hypoxia	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Nasal congestion	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Pharyngeal oedema	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Respiratory tract congestion	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Restrictive pulmonary disease	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Tachypnoea	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Throat irritation	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Throat tightness	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Wheezing	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Skin and subcutaneous tissue disorders
Urticaria	10/26 (38.5%)		3/35 (8.6%)		13/61 (21.3%)
Rash	3/26 (11.5%)		7/35 (20%)		10/61 (16.4%)
Blister	2/26 (7.7%)		0/35 (0%)		2/61 (3.3%)
Ecchymosis	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Pruritus generalised	0/26 (0%)		2/35 (5.7%)		2/61 (3.3%)
Alopecia	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Dermatitis acneiform	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Dermatitis allergic	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Dry skin	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Erythema	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Hyperhidrosis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Petechiae	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Psoriasis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Rash generalised	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Rash maculo-papular	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Skin chapped	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Skin lesion	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Skin ulcer	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)
Vascular disorders
Hypotension	1/26 (3.8%)		2/35 (5.7%)		3/61 (4.9%)
Hot flush	1/26 (3.8%)		1/35 (2.9%)		2/61 (3.3%)
Deep vein thrombosis	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Flushing	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Hypertension	1/26 (3.8%)		0/35 (0%)		1/61 (1.6%)
Jugular vein thrombosis	0/26 (0%)		1/35 (2.9%)		1/61 (1.6%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title	GSK Response Center
Organization	GlaxoSmithKline
Phone	866-435-7343
Email

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00823719

Other Study ID Numbers:

110927

First Posted:

Jan 16, 2009

Last Update Posted:

Mar 12, 2013

Last Verified:

Feb 1, 2013

Phase II Study of Ofatumumab Plus Ifosfamide, Carboplatin, Etoposide (ICE) or Dexamethasone, Cytarabine, Cisplatin (DHAP) Chemotherapy Regimen in Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL)

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