Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01363297
• Collaborator: UCB Pharma (Industry)
• Enrollment: 72
• Locations: 15
• Arm: 1
• Duration (Months): 53
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in second or later salvage status.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphocytic Leukemia	Drug: Inotuzumab Ozogamicin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Phase 1/2 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory Cd22-positive Acute Lymphocytic Leukemia
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inotuzumab Ozogamicin	Drug: Inotuzumab Ozogamicin; Part 1: Administered intravenously as 2 - 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total dose per cycle 0.8 mg/m^2 to 2.0 mg/m^2. Part 2 Expansion and Part 3 Phase 2: Administered intravenously as 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total initial dose per cycle 1.8 mg/m^2.; Other Names: CMC-544

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Reporting Dose Limiting Toxicities (DLTs) During the Phase 1 Dose-Finding Phase [Cycle 1]

   DLT was any of the following in the first cycle & attributable to inotuzumab ozogamicin: any greater than or equal to (≥) Grade 4 non-hematologic toxicity except nausea/vomiting (if manageable with supportive care), alopecia, & toxicities secondary to neutropenia & sepsis; prolonged myelosuppression (absolute neutrophil count [ANC] less than [<] 500 per microliter [/µL] or platelet count <25,000/µL in bone marrow with <5 percent (%) blasts & no evidence of leukemia more than 45 days beyond the most recent dose of test article); any Grade 3 non-hematologic toxicity (excluding toxicities such as alopecia or those secondary to neutropenia & sepsis) not resolving to ≥ Grade 2 within 7 days of the most recent dose of test article or was clinically significant irrespective of duration; any ≥ Grade 3 elevation of alanine aminotransferase, aspartate aminotransferase or bilirubin lasting ≥7 days; any test article related toxicity resulting in permanent discontinuation of test article.

2. Percentage of Participants With Preliminary Satisfactory Response (Complete Response [CR], CR With Incomplete Count Recovery [CRi], Partial Response [PR], or Resistant Disease [RD]) Indicating Disease Stability After First Dose During Phase 1 Dose-Finding [From screening to progressive disease or another induction therapy started, up to approximately 2 years]

   CR was the disappearance of leukemia indicated by <5% marrow blasts and absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was as for CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was an improved or no worsening of acute lymphocytic leukemia indicated by no peripheral blood blasts, and/or at least a 50% decrease in the marrow blast percentage, compared to pre-treatment value, and marrow blast percentage ≥5% and less than or equal to (≤)25% and/or C2 extramedullary disease status. RD occurred if a participant survived ≥7 days following completion of initial treatment course and had persistent leukemia in the most recent peripheral blood smear or bone marrow and/or persistent disease involvement at any extramedullary site after completion of therapy.

3. Percentage of Participants With CR or CRi During Phase 2 [From screening to progressive disease or another induction therapy started, up to approximately 2 years]

   CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL.

4. Percentage of Participants With CR, CRi or PR During the Phase 1 Expansion Phase [From screening to progressive disease or another induction therapy started, up to approximately 2 years]

   CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was defined as an improved or no worsening of acute lymphocytic leukemia as indicated by no peripheral blood blasts, and either or both of the following: at least a 50% decrease in the marrow blast percentage, compared to the pre-treatment value, and marrow blast percentage ≥5% and ≤25% and/or C2 extramedullary disease status.

Secondary Outcome Measures

1. Percentage of Participants With CR, CRi or PR in Phase 2 [From screening to progressive disease or another induction therapy started, up to approximately 2 years]

   CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was defined as an improved or no worsening of acute lymphocytic leukemia as indicated by no peripheral blood blasts, and either or both of the following: at least a 50% decrease in the marrow blast percentage, compared to the pre-treatment value, and marrow blast percentage ≥5% and ≤25% and/or C2 extramedullary disease status.

2. Number of Participants With Minimal Residual Disease (MRD) Negativity in Participants Achieving CR and CRi [From screening to progressive disease or another induction therapy started, up to approximately 2 years]

   MRD negativity was defined as <0.01% mononuclear cells.

3. Percentage of Participants With CR or CRi by Cytogenetic Category [From screening to progressive disease or another induction therapy started, up to approximately 2 years]

   CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL.

4. Percentage of Participants Who Had a Post-Treatment Stem-Cell Transplant (SCT) [Up to approximately 2 years from first dose]

   Post-treatment SCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin.

5. Progression Free Survival (PFS) [Up to approximately 2 years from first dose]

   PFS was defined as the time from Cycle 1 Day 1 to first documentation of PFS event (earliest date of objective progression [PD], treatment discontinuation due to global deterioration of health status, subsequent induction or transplant after best response of PR or resistant disease, relapse after CR or CRi, or death due to any cause). Participants last known to be 1) alive and 2) without a PFS event, were censored at the date of the last disease assessment that verified lack of event.

6. Duration of Remission (DoR1) for Participants Who Achieved CR or CRi [Up to approximately 2 years from first dose]

   DoR1 was defined for participants who responded as the time from the date of first documentation of Complete Hematologic Response (CR or CRi) to the date of the first documentation of relapse after CR or CRi, treatment discontinuation due to global deterioration of health status) or to death due to any cause. Participants last known to be 1) alive and 2) without a DoR1 event, were censored at the date of the last disease assessment that verified lack of event.

7. Duration of Response (DoR) for Participants Who Achieved CR/CRi or PR [Up to approximately 2 years from first dose]

   DoR was defined for participants who respond as the time from the date of first documentation of Hematologic Response (CR, CRi, or PR) to the date of the first documentation of DoR event (earliest date of PD, treatment discontinuation due to global deterioration of health status, first induction therapy or transplant after PR, relapse after CR or CRi or death due to any cause). Participants last known to be 1) alive and 2) without a DoR event, were censored at the date of the last disease assessment that verified lack of event.

8. Overall Survival (OS) [Up to approximately 2 years from first dose]

   OS was defined as the time from Cycle 1 Day 1 to date of death due to any cause. If death was not documented, censoring occurred at the date at which the participant was last known to be alive.

9. Time to Remission for Participants Who Achieved CR or CRi [Up to approximately 2 years from first dose]

   Time to remission was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic remission (CR or CRi) in participants achieving remission during study therapy.

10. Time to Response for Participants Who Achieved CR/CRi or PR [Up to approximately 2 years from first dose]

    Time to response was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic response (CR, CRi, or PR).

11. Time to MRD Negativity for Participants Who Achieved CR or CRi [Screening, Day 21 of Cycles 1 to 6 and up to 4 to 6 weeks after the last dose (up to 34 weeks)]

    Time to MRD negativity was defined as the time from the date of first dose of study drug to the date of first documentation of MRD negativity.

12. Duration of Follow-Up [From first dose up to approximately 2 years]

    Duration of follow-up was defined as the time from the date of first dose of study drug to the date of last contact for participants known to be alive.

13. Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit [Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4]

    CD22+ leukemic blasts assessed in abnormal B cells from blood (data from central laboratories only).

14. Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit [Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4]

    CD22+ leukemic blasts assessed in abnormal B cells from bone marrow (data from central laboratories only).

15. Messenger Ribonucleic Acid (mRNA) Gene Expression [Predose and postdose on Days 1 and 15 of Cycle 1]

    Optional blood samples for pharmacogenomic parameters were collected during Cycle 1 prior to the start of the inotuzumab ozogamicin infusion (0 hours) and 1 hour post-dose (original Final Protocol and Protocol Amendments 1 and 2) or 3 hours post-dose (Protocol Amendments 3 and 4) on Day 1 and Day 15 from those participants who provided consent. Gene expression analysis of samples collected pre- and post-dosing was performed using 96-gene TaqMan® low density array cards to examine the concordance between clinical outcome and expression of genes such as those involved in DNA damage response, apoptosis, B-cell antigen expression, glutathione metabolism, drug transport and the phosphoinositide 3-kinase/mammalian target of rapamycin pathway. Expression for each gene was reported as a normalized value, 2^-change in (∆) threshold cycle (Ct), where ∆Ct is Ct^target gene minus Ct^reference genes, averaged.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with CD22-positive ALL with either refractory disease (i.e. disease progression or no response while receiving their most recent prior anti-cancer therapy), or relapsed disease (i.e. response to their most recent prior anti-cancer therapy with subsequent relapse). Subjects enrolled in the Phase 2 portion of the study must be due to receive salvage 2 or later therapy.

• Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor.

• Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

• Subjects with isolated extramedullary relapse or active central nervous system (CNS) leukemia.

• Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry.

• Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States	91010-3000
2	Stanford Unversity Cancer Clinical Trials Office	Palo Alto	California	United States	94304
3	Stanford Unversity Hospital and Clinics, CTRU	Palo Alto	California	United States	94304
4	Stanford Cancer Institute	Stanford	California	United States	94305
5	Stanford University Hospital and Clinics	Stanford	California	United States	94305
6	The University of Chicago Medical Center	Chicago	Illinois	United States	60637
7	Massachusetts General Hospital (MGH)	Boston	Massachusetts	United States	02114
8	Brigham and Women's Hospital (BWH)	Boston	Massachusetts	United States	02115
9	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
10	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
11	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
12	Karmanos Cancer Institute at Farmington Hills	Farmington Hills	Michigan	United States	48334
13	Cleveland Clinic	Cleveland	Ohio	United States	44195
14	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
15	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Pfizer
• UCB Pharma

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01363297
• Other Study ID Numbers: B1931010; 3129K6-1106
• First Posted: Jun 1, 2011
• Last Update Posted: Apr 13, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Pfizer: Relapsed/Refractory Acute Lymphocytic Leukemia (ALL)
• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Inotuzumab Ozogamicin

Study Results

Participant Flow

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Period Title: Overall Study
STARTED	3	12	9	13	35
COMPLETED	0	6	3	3	4
NOT COMPLETED	3	6	6	10	31

Baseline Characteristics

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	Total
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	Total of all reporting groups
Overall Participants	3	12	9	13	35	72
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	63.7 (1.53)	44.9 (18.06)	43.1 (18.37)	53.4 (13.82)	40.7 (17.08)	44.9 (17.26)
Sex: Female, Male (Count of Participants)
Female	0 0%	1 8.3%	6 66.7%	6 46.2%	8 22.9%	21 29.2%
Male	3 100%	11 91.7%	3 33.3%	7 53.8%	27 77.1%	51 70.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Reporting Dose Limiting Toxicities (DLTs) During the Phase 1 Dose-Finding Phase
Description	DLT was any of the following in the first cycle & attributable to inotuzumab ozogamicin: any greater than or equal to (≥) Grade 4 non-hematologic toxicity except nausea/vomiting (if manageable with supportive care), alopecia, & toxicities secondary to neutropenia & sepsis; prolonged myelosuppression (absolute neutrophil count [ANC] less than [<] 500 per microliter [/µL] or platelet count <25,000/µL in bone marrow with <5 percent (%) blasts & no evidence of leukemia more than 45 days beyond the most recent dose of test article); any Grade 3 non-hematologic toxicity (excluding toxicities such as alopecia or those secondary to neutropenia & sepsis) not resolving to ≥ Grade 2 within 7 days of the most recent dose of test article or was clinically significant irrespective of duration; any ≥ Grade 3 elevation of alanine aminotransferase, aspartate aminotransferase or bilirubin lasting ≥7 days; any test article related toxicity resulting in permanent discontinuation of test article.
Time Frame	Cycle 1

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	3	12	9
Number [Percentage of Participants]	0 0%	0 0%	11.1 123.3%

2. Primary Outcome

Title	Percentage of Participants With Preliminary Satisfactory Response (Complete Response [CR], CR With Incomplete Count Recovery [CRi], Partial Response [PR], or Resistant Disease [RD]) Indicating Disease Stability After First Dose During Phase 1 Dose-Finding
Description	CR was the disappearance of leukemia indicated by <5% marrow blasts and absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was as for CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was an improved or no worsening of acute lymphocytic leukemia indicated by no peripheral blood blasts, and/or at least a 50% decrease in the marrow blast percentage, compared to pre-treatment value, and marrow blast percentage ≥5% and less than or equal to (≤)25% and/or C2 extramedullary disease status. RD occurred if a participant survived ≥7 days following completion of initial treatment course and had persistent leukemia in the most recent peripheral blood smear or bone marrow and/or persistent disease involvement at any extramedullary site after completion of therapy.
Time Frame	From screening to progressive disease or another induction therapy started, up to approximately 2 years

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	3	12	9
Number [Percentage of Participants]	100 3333.3%	91.7 764.2%	88.9 987.8%

3. Primary Outcome

Title	Percentage of Participants With CR or CRi During Phase 2
Description	CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL.
Time Frame	From screening to progressive disease or another induction therapy started, up to approximately 2 years

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2
Arm/Group Description	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	35
Number (90% Confidence Interval) [Percentage of Partcicipants]	68.6

4. Primary Outcome

Title	Percentage of Participants With CR, CRi or PR During the Phase 1 Expansion Phase
Description	CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was defined as an improved or no worsening of acute lymphocytic leukemia as indicated by no peripheral blood blasts, and either or both of the following: at least a 50% decrease in the marrow blast percentage, compared to the pre-treatment value, and marrow blast percentage ≥5% and ≤25% and/or C2 extramedullary disease status.
Time Frame	From screening to progressive disease or another induction therapy started, up to approximately 2 years

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2
Arm/Group Description	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	13
Number (95% Confidence Interval) [Percentage of Partcicipants]	46.2

5. Secondary Outcome

Title	Percentage of Participants With CR, CRi or PR in Phase 2
Description	CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was defined as an improved or no worsening of acute lymphocytic leukemia as indicated by no peripheral blood blasts, and either or both of the following: at least a 50% decrease in the marrow blast percentage, compared to the pre-treatment value, and marrow blast percentage ≥5% and ≤25% and/or C2 extramedullary disease status.
Time Frame	From screening to progressive disease or another induction therapy started, up to approximately 2 years

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2
Arm/Group Description	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	35
Number (95% Confidence Interval) [Percentage of Partcicipants]	74.3

6. Secondary Outcome

Title	Number of Participants With Minimal Residual Disease (MRD) Negativity in Participants Achieving CR and CRi
Description	MRD negativity was defined as <0.01% mononuclear cells.
Time Frame	From screening to progressive disease or another induction therapy started, up to approximately 2 years

Outcome Measure Data

Analysis Population Description

Number of participants who achieved CR and CRi

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	2	9	8	6	24	49
Number [Participants]	2 66.7%	8 66.7%	8 88.9%	5 38.5%	18 51.4%	41 56.9%

7. Secondary Outcome

Title	Percentage of Participants With CR or CRi by Cytogenetic Category
Description	CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL.
Time Frame	From screening to progressive disease or another induction therapy started, up to approximately 2 years

Outcome Measure Data

Analysis Population Description

Safety analysis set (n refers to number of participants evaluated)

Arm/Group Title	All Doses
Arm/Group Description
Measure Participants	72
Normal (n=13)	86.7 2890%
Complex (n=10)	66.7 2223.3%
Ph+ (n=9)	56.3 1876.7%
Other (n=13)	65.0 2166.7%
Unknown (n=3)	75.0 2500%
Missing (n=1)	50 1666.7%

8. Secondary Outcome

Title	Percentage of Participants Who Had a Post-Treatment Stem-Cell Transplant (SCT)
Description	Post-treatment SCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin.
Time Frame	Up to approximately 2 years from first dose

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	3	12	9	13	35	72
Number [Percentage of Particicpants]	0	75.0	44.4	23.1	22.9	33.3

9. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	PFS was defined as the time from Cycle 1 Day 1 to first documentation of PFS event (earliest date of objective progression [PD], treatment discontinuation due to global deterioration of health status, subsequent induction or transplant after best response of PR or resistant disease, relapse after CR or CRi, or death due to any cause). Participants last known to be 1) alive and 2) without a PFS event, were censored at the date of the last disease assessment that verified lack of event.
Time Frame	Up to approximately 2 years from first dose

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	3	12	9	13	35	72
Median (95% Confidence Interval) [Months]	5.5	NA	8.8	1.9	3.7	3.9

10. Secondary Outcome

Title	Duration of Remission (DoR1) for Participants Who Achieved CR or CRi
Description	DoR1 was defined for participants who responded as the time from the date of first documentation of Complete Hematologic Response (CR or CRi) to the date of the first documentation of relapse after CR or CRi, treatment discontinuation due to global deterioration of health status) or to death due to any cause. Participants last known to be 1) alive and 2) without a DoR1 event, were censored at the date of the last disease assessment that verified lack of event.
Time Frame	Up to approximately 2 years from first dose

Outcome Measure Data

Analysis Population Description

All participants who achieved CR or CRi

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	2	9	8	6	24	49
Median (95% Confidence Interval) [Months]	4.7	NA	10.8	7.1	3.8	4.8

11. Secondary Outcome

Title	Duration of Response (DoR) for Participants Who Achieved CR/CRi or PR
Description	DoR was defined for participants who respond as the time from the date of first documentation of Hematologic Response (CR, CRi, or PR) to the date of the first documentation of DoR event (earliest date of PD, treatment discontinuation due to global deterioration of health status, first induction therapy or transplant after PR, relapse after CR or CRi or death due to any cause). Participants last known to be 1) alive and 2) without a DoR event, were censored at the date of the last disease assessment that verified lack of event.
Time Frame	Up to approximately 2 years from first dose

Outcome Measure Data

Analysis Population Description

All participants who achieved CR, CRi or PR.

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	2	11	8	6	26	53
Median (95% Confidence Interval) [Weeks]	20.50	NA	46.93	31.07	16.57	18.71

12. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was defined as the time from Cycle 1 Day 1 to date of death due to any cause. If death was not documented, censoring occurred at the date at which the participant was last known to be alive.
Time Frame	Up to approximately 2 years from first dose

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	3	12	9	13	35	72
Median (95% Confidence Interval) [Months]	9.2	NA	16.5	5.8	6.4	7.4

13. Secondary Outcome

Title	Time to Remission for Participants Who Achieved CR or CRi
Description	Time to remission was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic remission (CR or CRi) in participants achieving remission during study therapy.
Time Frame	Up to approximately 2 years from first dose

Outcome Measure Data

Analysis Population Description

All participants who achieved CR or CRi

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	2	9	8	6	24	49
Median (Full Range) [Days]	39.0 (24.04)	29.0 (12.60)	38.0 (19.88)	27.0 (29.18)	25.5 (22.12)	27.0 (20.75)

14. Secondary Outcome

Title	Time to Response for Participants Who Achieved CR/CRi or PR
Description	Time to response was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic response (CR, CRi, or PR).
Time Frame	Up to approximately 2 years from first dose

Outcome Measure Data

Analysis Population Description

All participants who achieved CR, CRi or PR.

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	2	11	8	6	26	53
Median (Full Range) [Days]	39.0 (24.04)	29.0 (9.01)	27.0 (20.66)	24.0 (10.09)	23.0 (10.22)	25.0 (12.45)

15. Secondary Outcome

Title	Time to MRD Negativity for Participants Who Achieved CR or CRi
Description	Time to MRD negativity was defined as the time from the date of first dose of study drug to the date of first documentation of MRD negativity.
Time Frame	Screening, Day 21 of Cycles 1 to 6 and up to 4 to 6 weeks after the last dose (up to 34 weeks)

Outcome Measure Data

Analysis Population Description

All participants who achieved CR/CRi and MRD negativity.

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	2	8	8	5	18	41
Median (Full Range) [Days]	98.5 (0.71)	32.0 (15.17)	30.0 (50.54)	25.0 (48.09)	25.5 (18.66)	29.0 (32.73)

16. Secondary Outcome

Title	Duration of Follow-Up
Description	Duration of follow-up was defined as the time from the date of first dose of study drug to the date of last contact for participants known to be alive.
Time Frame	From first dose up to approximately 2 years

Outcome Measure Data

Analysis Population Description

Participants who were alive

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	0	6	3	3	5	17
Median (95% Confidence Interval) [Months]	24.0	25.7	24.1	24.2	24.1

17. Secondary Outcome

Title	Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit
Description	CD22+ leukemic blasts assessed in abnormal B cells from blood (data from central laboratories only).
Time Frame	Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	3	12	9	13	35	72
Screening	NA	NA	NA	93.7	NA	93.7
Cycle 1 Day 1	99.7	98.1	98.4	96.4	98.7	98.0
Cycle 1 Day 15	66.2	79.0	0.0	71.4	74.8	69.9
Cycle 2 Day 1	52.0	0.0	0.0	2.8	0.0	0.0
Cycle 2 Day 15	0.0	0.0	0.0	0.5	0.0	0.0
Cycle 4 Day 1	49.2	0.0	0.0	0.0	0.0	0.0
End of Treatment	99.0	NA	NA	NA	NA	99.0

18. Secondary Outcome

Title	Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit
Description	CD22+ leukemic blasts assessed in abnormal B cells from bone marrow (data from central laboratories only).
Time Frame	Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2	All Doses
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles	IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
Measure Participants	3	12	9	13	35	72
Screening	99.6	98.7	98.4	95.1	99.2	99.0
Cycle 1 Day 21	NA	NA	99	56.5	70.7	72.3
Cycle 1 Day 28	75.5	54.1	26.5	74.1	94.5	56.6
Cycle 2 Day 21	NA	0.0	NA	NA	0.0	0.0
Cycle 2 Day 28	52.9	0.0	0.0	2.9	6.8	0.0
Cycle 3 Day 21	NA	NA	0.0	0.0	0.0	0.0
Cycle 3 Day 28	50.0	0.0	0.0	0.0	25.1	0.0
Cycle 4 Day 21	97	NA	NA	NA	11.6	23.2
Cycle 4 Day 28	0.0	0.0	14.3	29.4	36	1.9
Cycle 5 Day 21	NA	NA	NA	0.0	66.4	48.1
Cycle 5 Day 28	0.0	NA	NA	79.1	NA	39.6
Cycle 6 Day 21	NA	NA	NA	0.0	74	0.0
End of Treatment	100	0.0	0.0	6.6	0.0	0.0

19. Secondary Outcome

Title	Messenger Ribonucleic Acid (mRNA) Gene Expression
Description	Optional blood samples for pharmacogenomic parameters were collected during Cycle 1 prior to the start of the inotuzumab ozogamicin infusion (0 hours) and 1 hour post-dose (original Final Protocol and Protocol Amendments 1 and 2) or 3 hours post-dose (Protocol Amendments 3 and 4) on Day 1 and Day 15 from those participants who provided consent. Gene expression analysis of samples collected pre- and post-dosing was performed using 96-gene TaqMan® low density array cards to examine the concordance between clinical outcome and expression of genes such as those involved in DNA damage response, apoptosis, B-cell antigen expression, glutathione metabolism, drug transport and the phosphoinositide 3-kinase/mammalian target of rapamycin pathway. Expression for each gene was reported as a normalized value, 2^-change in (∆) threshold cycle (Ct), where ∆Ct is Ct^target gene minus Ct^reference genes, averaged.
Time Frame	Predose and postdose on Days 1 and 15 of Cycle 1

Outcome Measure Data

Analysis Population Description

Pharmacogenomics population - included all enrolled participants who received at least 1 dose of any study drug, and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment.

Arm/Group Title	Pharmacogenomics Population
Arm/Group Description	All participants who gave consent for the optional blood sample for pharmacogenomic analyses, received at least 1 dose of any study drug, and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment.
Measure Participants	55
ABCB1: Cycle 1 Day 1, Baseline (n=55)	0.00421
ABCB1: Cycle 1 Day 1, Post-dose (n=51)	0.00440
ABCB1: Cycle 1 Day 15, 0 hours (n=48)	0.00746
ABCB1: Cycle 1 Day 15, Post-dose (n=46)	0.00783
ABCC1: Cycle 1 Day 1, Baseline (n=55)	0.01983
ABCC1: Cycle 1 Day 1, Post-dose (n=52)	0.02245
ABCC1: Cycle 1 Day 15, 0 hours (n=48)	0.01453
ABCC1: Cycle 1 Day 15, Post-dose (n=46)	0.01497
ABCC2: Cycle 1 Day 1, Baseline (n=53)	0.00064
ABCC2: Cycle 1 Day 1, Post-dose (n=48)	0.00072
ABCC2: Cycle 1 Day 15, 0 hours (n=40)	0.00072
ABCC2: Cycle 1 Day 15, Post-dose (n=38)	0.00078
ABCG2: Cycle 1 Day 1, Baseline (n=55)	0.00491
ABCG2: Cycle 1 Day 1, Post-dose (n=51)	0.00660
ABCG2: Cycle 1 Day 15, 0 hours (n=46)	0.01582
ABCG2: Cycle 1 Day 15, Post-dose (n=45)	0.01845
ABL1: Cycle 1 Day 1, Baseline (n=55)	0.03297
ABL1: Cycle 1 Day 1, Post-dose (n=52)	0.02899
ABL1: Cycle 1 Day 15, 0 hours (n=48)	0.01369
ABL1: Cycle 1 Day 15, Post-dose (n=46)	0.01381
ABL2: Cycle 1 Day 1, Baseline (n=55)	0.00916
ABL2: Cycle 1 Day 1, Post-dose (n=52)	0.00867
ABL2: Cycle 1 Day 15, 0 hours (n=48)	0.00613
ABL2: Cycle 1 Day 15, Post-dose (n=46)	0.00547
ACTB: Cycle 1 Day 1, Baseline (n=55)	1.73899
ACTB: Cycle 1 Day 1, Post-dose (n=52)	1.95092
ACTB: Cycle 1 Day 15, 0 hours (n=48)	2.14694
ACTB: Cycle 1 Day 15, Post-dose (n=46)	2.11584
AKT1: Cycle 1 Day 1, Baseline (n=55)	0.03212
AKT1: Cycle 1 Day 1, Post-dose (n=52)	0.03164
AKT1: Cycle 1 Day 15, 0 hours (n=48)	0.02740
AKT1: Cycle 1 Day 15, Post-dose (n=46)	0.02987
ALG5: Cycle 1 Day 1, Baseline (n=55)	0.00455
ALG5: Cycle 1 Day 1, Post-dose (n=52)	0.00419
ALG5: Cycle 1 Day 15, 0 hours (n=48)	0.00302
ALG5: Cycle 1 Day 15, Post-dose (n=46)	0.00265
APAF1: Cycle 1 Day 1, Baseline (n=55)	0.03880
APAF1: Cycle 1 Day 1, Post-dose (n=52)	0.03740
APAF1: Cycle 1 Day 15, 0 hours (n=48)	0.03754
APAF1: Cycle 1 Day 15, Post-dose (n=46)	0.03708
ATM: Cycle 1 Day 1, Baseline (n=55)	0.06441
ATM: Cycle 1 Day 1, Post-dose (n=52)	0.06615
ATM: Cycle 1 Day 15, 0 hours (n=48)	0.06927
ATM: Cycle 1 Day 15, Post-dose (n=46)	0.05951
ATRX: Cycle 1 Day 1, Baseline (n=55)	0.06123
ATRX: Cycle 1 Day 1, Post-dose (n=52)	0.05679
ATRX: Cycle 1 Day 15, 0 hours (n=48)	0.05456
ATRX: Cycle 1 Day 15, Post-dose (n=46)	0.05662
B2M: Cycle 1 Day 1, Baseline (n=55)	3.81650
B2M: Cycle 1 Day 1, Post-dose (n=52)	3.89919
B2M: Cycle 1 Day 15, 0 hours (n=48)	5.97465
B2M: Cycle 1 Day 15, Post-dose (n=46)	6.21338
BAD: Cycle 1 Day 1, Baseline (n=55)	0.00099
BAD: Cycle 1 Day 1, Post-dose (n=52)	0.00100
BAD: Cycle 1 Day 15, 0 hours (n=47)	0.00085
BAD: Cycle 1 Day 15, Post-dose (n=43)	0.00077
BAK1: Cycle 1 Day 1, Baseline (n=55)	0.01991
BAK1: Cycle 1 Day 1, Post-dose (n=52)	0.01658
BAK1: Cycle 1 Day 15, 0 hours (n=48)	0.01490
BAK1: Cycle 1 Day 15, Post-dose (n=46)	0.01405
BAX: Cycle 1 Day 1, Baseline (n=55)	0.07686
BAX: Cycle 1 Day 1, Post-dose (n=52)	0.07420
BAX: Cycle 1 Day 15, 0 hours (n=48)	0.07107
BAX: Cycle 1 Day 15, Post-dose (n=46)	0.06543
BBC3: Cycle 1 Day 1, Baseline (n=55)	0.01174
BBC3: Cycle 1 Day 1, Post-dose (n=52)	0.01197
BBC3: Cycle 1 Day 15, 0 hours (n=48)	0.01470
BBC3: Cycle 1 Day 15, Post-dose (n=46)	0.01449
BCL2: Cycle 1 Day 1, Baseline (n=55)	0.02425
BCL2: Cycle 1 Day 1, Post-dose (n=52)	0.02200
BCL2: Cycle 1 Day 15, 0 hours (n=48)	0.01979
BCL2: Cycle 1 Day 15, Post-dose (n=46)	0.01648
BCL2L1: Cycle 1 Day 1, Baseline (n=55)	0.83473
BCL2L1: Cycle 1 Day 1, Post-dose (n=52)	1.12931
BCL2L1: Cycle 1 Day 15, 0 hours (n=48)	3.05721
BCL2L1: Cycle 1 Day 15, Post-dose (n=46)	3.98955
BCL2L11: Cycle 1 Day 1, Baseline (n=55)	0.03003
BCL2L11: Cycle 1 Day 1, Post-dose (n=52)	0.02970
BCL2L11: Cycle 1 Day 15, 0 hours (n=48)	0.03865
BCL2L11: Cycle 1 Day 15, Post-dose (n=46)	0.04259
BCR: Cycle 1 Day 1, Baseline (n=7)	0.02294
BCR: Cycle 1 Day 1, Post-dose (n=5)	0.02135
BCR: Cycle 1 Day 15, 0 hours (n=3)	0.00116
BCR: Cycle 1 Day 15, Post-dose (n=2)	0.00817
BID: Cycle 1 Day 1, Baseline (n=55)	0.01794
BID: Cycle 1 Day 1, Post-dose (n=52)	0.01528
BID: Cycle 1 Day 15, 0 hours (n=48)	0.01619
BID: Cycle 1 Day 15, Post-dose (n=46)	0.01448
BIK: Cycle 1 Day 1, Baseline (n=52)	0.00137
BIK: Cycle 1 Day 1, Post-dose (n=49)	0.00143
BIK: Cycle 1 Day 15, 0 hours (n=42)	0.00093
BIK: Cycle 1 Day 15, Post-dose (n=39)	0.00095
BMF: Cycle 1 Day 1, Baseline (n=55)	0.00604
BMF: Cycle 1 Day 1, Post-dose (n=52)	0.00705
BMF: Cycle 1 Day 15, 0 hours (n=47)	0.00333
BMF: Cycle 1 Day 15, Post-dose (n=46)	0.00341
BRCA1: Cycle 1 Day 1, Baseline (n=55)	0.00628
BRCA1: Cycle 1 Day 1, Post-dose (n=52)	0.00691
BRCA1: Cycle 1 Day 15, 0 hours (n=48)	0.00385
BRCA1: Cycle 1 Day 15, Post-dose (n=46)	0.00416
BRCA2: Cycle 1 Day 1, Baseline (n=50)	0.00059
BRCA2: Cycle 1 Day 1, Post-dose (n=44)	0.00067
BRCA2: Cycle 1 Day 15, 0 hours (n=34)	0.00045
BRCA2: Cycle 1 Day 15, Post-dose (n=35)	0.00049
CA6: Cycle 1 Day 1, Baseline (n=48)	0.00104
CA6: Cycle 1 Day 1, Post-dose (n=42)	0.00196
CA6: Cycle 1 Day 15, 0 hours (n=35)	0.00130
CA6: Cycle 1 Day 15, Post-dose (n=34)	0.00119
CASP2: Cycle 1 Day 1, Baseline (n=55)	0.04235
CASP2: Cycle 1 Day 1, Post-dose (n=52)	0.04162
CASP2: Cycle 1 Day 15, 0 hours (n=48)	0.03287
CASP2: Cycle 1 Day 15, Post-dose (n=46)	0.03283
CASP3: Cycle 1 Day 1, Baseline (n=55)	0.02380
CASP3: Cycle 1 Day 1, Post-dose (n=52)	0.02353
CASP3: Cycle 1 Day 15, 0 hours (n=48)	0.02168
CASP3: Cycle 1 Day 15, Post-dose (n=46)	0.02030
CASP7: Cycle 1 Day 1, Baseline (n=55)	0.01271
CASP7: Cycle 1 Day 1, Post-dose (n=52)	0.01354
CASP7: Cycle 1 Day 15, 0 hours (n=48)	0.00923
CASP7: Cycle 1 Day 15, Post-dose (n=46)	0.00833
CASP9: Cycle 1 Day 1, Baseline (n=55)	0.00772
CASP9: Cycle 1 Day 1, Post-dose (n=52)	0.00732
CASP9: Cycle 1 Day 15, 0 hours (n=48)	0.00707
CASP9: Cycle 1 Day 15, Post-dose (n=46)	0.00715
CCND1: Cycle 1 Day 1, Baseline (n=52)	0.00091
CCND1: Cycle 1 Day 1, Post-dose (n=49)	0.00071
CCND1: Cycle 1 Day 15, 0 hours (n=43)	0.00080
CCND1: Cycle 1 Day 15, Post-dose (n=37)	0.00078
CCNE1: Cycle 1 Day 1, Baseline (n=53)	0.00311
CCNE1: Cycle 1 Day 1, Post-dose (n=50)	0.00331
CCNE1: Cycle 1 Day 15, 0 hours (n=46)	0.00234
CCNE1: Cycle 1 Day 15, Post-dose (n=43)	0.00217
CD22: Cycle 1 Day 1, Baseline (n=55)	0.04313
CD22: Cycle 1 Day 1, Post-dose (n=51)	0.03359
CD22: Cycle 1 Day 15, 0 hours (n=35)	0.00120
CD22: Cycle 1 Day 15, Post-dose (n=32)	0.00130
CD24: Cycle 1 Day 1, Baseline (n=55)	0.31881
CD24: Cycle 1 Day 1, Post-dose (n=52)	0.36597
CD24: Cycle 1 Day 15, 0 hours (n=48)	0.02968
CD24: Cycle 1 Day 15, Post-dose (n=46)	0.05363
CD44: Cycle 1 Day 1, Baseline (n=55)	0.25285
CD44: Cycle 1 Day 1, Post-dose (n=52)	0.23497
CD44: Cycle 1 Day 15, 0 hours (n=48)	0.27359
CD44: Cycle 1 Day 15, Post-dose (n=46)	0.22892
CD70: Cycle 1 Day 1, Baseline (n=52)	0.00194
CD70: Cycle 1 Day 1, Post-dose (n=47)	0.00170
CD70: Cycle 1 Day 15, 0 hours (n=42)	0.00225
CD70: Cycle 1 Day 15, Post-dose (n=38)	0.00169
CDC25A: Cycle 1 Day 1, Baseline (n=53)	0.00337
CDC25A: Cycle 1 Day 1, Post-dose (n=50)	0.00334
CDC25A: Cycle 1 Day 15, 0 hours (n=45)	0.00115
CDC25A: Cycle 1 Day 15, Post-dose (n=36)	0.00116
CDK2: Cycle 1 Day 1, Baseline (n=55)	0.02026
CDK2: Cycle 1 Day 1, Post-dose (n=52)	0.01883
CDK2: Cycle 1 Day 15, 0 hours (n=48)	0.01109
CDK2: Cycle 1 Day 15, Post-dose (n=46)	0.01118
CDKN2A: Cycle 1 Day 1, Baseline (n=55)	0.00675
CDKN2A: Cycle 1 Day 1, Post-dose (n=52)	0.00667
CDKN2A: Cycle 1 Day 15, 0 hours (n=48)	0.00676
CDKN2A: Cycle 1 Day 15, Post-dose (n=46)	0.00661
CHEK2: Cycle 1 Day 1, Baseline (n=55)	0.00257
CHEK2: Cycle 1 Day 1, Post-dose (n=51)	0.00224
CHEK2: Cycle 1 Day 15, 0 hours (n=47)	0.00206
CHEK2: Cycle 1 Day 15, Post-dose (n=46)	0.00234
DAPK1: Cycle 1 Day 1, Baseline (n=55)	0.02015
DAPK1: Cycle 1 Day 1, Post-dose (n=52)	0.02089
DAPK1: Cycle 1 Day 15, 0 hours (n=48)	0.01627
DAPK1: Cycle 1 Day 15, Post-dose (n=46)	0.01769
DCLRE1C: Cycle 1 Day 1, Baseline (n=55)	0.01404
DCLRE1C: Cycle 1 Day 1, Post-dose (n=52)	0.01226
DCLRE1C: Cycle 1 Day 15, 0 hours (n=48)	0.00845
DCLRE1C: Cycle 1 Day 15, Post-dose (n=46)	0.00875
DDIT4L: Cycle 1 Day 1, Baseline (n=46)	0.00091
DDIT4L: Cycle 1 Day 1, Post-dose (n=41)	0.00081
DDIT4L: Cycle 1 Day 15, 0 hours (n=18)	0.00058
DDIT4L: Cycle 1 Day 15, Post-dose (n=13)	0.00052
EBF1: Cycle 1 Day 1, Baseline (n=55)	0.02830
EBF1: Cycle 1 Day 1, Post-dose (n=51)	0.02492
EBF1: Cycle 1 Day 15, 0 hours (n=35)	0.00112
EBF1: Cycle 1 Day 15, Post-dose (n=34)	0.00112
EEF1D: Cycle 1 Day 1, Baseline (n=55)	0.00250
EEF1D: Cycle 1 Day 1, Post-dose (n=52)	0.00246
EEF1D: Cycle 1 Day 15, 0 hours (n=48)	0.00181
EEF1D: Cycle 1 Day 15, Post-dose (n=46)	0.00186
FADD: Cycle 1 Day 1, Baseline (n=55)	0.00436
FADD: Cycle 1 Day 1, Post-dose (n=52)	0.00487
FADD: Cycle 1 Day 15, 0 hours (n=48)	0.00434
FADD: Cycle 1 Day 15, Post-dose (n=46)	0.00477
FAS: Cycle 1 Day 1, Baseline (n=55)	0.02458
FAS: Cycle 1 Day 1, Post-dose (n=52)	0.02634
FAS: Cycle 1 Day 15, 0 hours (n=48)	0.03444
FAS: Cycle 1 Day 15, Post-dose (n=46)	0.03547
FASLG: Cycle 1 Day 1, Baseline (n=55)	0.00312
FASLG: Cycle 1 Day 1, Post-dose (n=52)	0.00343
FASLG: Cycle 1 Day 15, 0 hours (n=48)	0.00873
FASLG: Cycle 1 Day 15, Post-dose (n=46)	0.00820
GAPDH: Cycle 1 Day 1, Baseline (n=55)	0.77798
GAPDH: Cycle 1 Day 1, Post-dose (n=52)	0.74570
GAPDH: Cycle 1 Day 15, 0 hours (n=48)	0.46996
GAPDH: Cycle 1 Day 15, Post-dose (n=46)	0.43709
GLI3: Cycle 1 Day 1, Baseline (n=35)	0.00098
GLI3: Cycle 1 Day 1, Post-dose (n=29)	0.00107
GLI3: Cycle 1 Day 15, 0 hours (n=10)	0.00041
GLI3: Cycle 1 Day 15, Post-dose (n=8)	0.00054
GSTA2: Cycle 1 Day 1, Baseline (n=22)	0.00218
GSTA2: Cycle 1 Day 1, Post-dose (n=6)	0.00033
GSTA2: Cycle 1 Day 15, Post-dose (n=2)	0.00069
GSTM1: Cycle 1 Day 1, Baseline (n=37)	0.00958
GSTM1: Cycle 1 Day 1, Post-dose (n=35)	0.00885
GSTM1: Cycle 1 Day 15, 0 hours (n=34)	0.00706
GSTM1: Cycle 1 Day 15, Post-dose (n=31)	0.00642
GSTM4: Cycle 1 Day 1, Baseline (n=54)	0.00260
GSTM4: Cycle 1 Day 1, Post-dose (n=50)	0.00237
GSTM4: Cycle 1 Day 15, 0 hours (n=47)	0.00226
GSTM4: Cycle 1 Day 15, Post-dose (n=44)	0.00225
GSTM5: Cycle 1 Day 1, Baseline (n=29)	0.00045
GSTM5: Cycle 1 Day 1, Post-dose (n=24)	0.00050
GSTM5: Cycle 1 Day 15, 0 hours (n=19)	0.00065
GSTM5: Cycle 1 Day 15, Post-dose (n=19)	0.00094
GSTP1: Cycle 1 Day 1, Baseline (n=55)	0.28876
GSTP1: Cycle 1 Day 1, Post-dose (n=52)	0.28295
GSTP1: Cycle 1 Day 15, 0 hours (n=48)	0.19381
GSTP1: Cycle 1 Day 15, Post-dose (n=46)	0.19224
GSTT1: Cycle 1 Day 1, Baseline (n=40)	0.00061
GSTT1: Cycle 1 Day 1, Post-dose (n=35)	0.00065
GSTT1: Cycle 1 Day 15, 0 hours (n=29)	0.00064
GSTT1: Cycle 1 Day 15, Post-dose (n=28)	0.00066
HRK: Cycle 1 Day 1, Baseline (n=48)	0.00136
HRK: Cycle 1 Day 1, Post-dose (n=41)	0.00108
HRK: Cycle 1 Day 15, 0 hours (n=11)	0.00075
HRK: Cycle 1 Day 15, Post-dose (n=13)	0.00055
IKZF1: Cycle 1 Day 1, Baseline (n=55)	0.22553
IKZF1: Cycle 1 Day 1, Post-dose (n=52)	0.25975
IKZF1: Cycle 1 Day 15, 0 hours (n=48)	0.23670
IKZF1: Cycle 1 Day 15, Post-dose (n=46)	0.23925
KMT2A: Cycle 1 Day 1, Baseline (n=55)	0.03764
KMT2A: Cycle 1 Day 1, Post-dose (n=52)	0.03459
KMT2A: Cycle 1 Day 15, 0 hours (n=48)	0.02499
KMT2A: Cycle 1 Day 15, Post-dose (n=46)	0.02138
KRT20: Cycle 1 Day 1, Baseline (n=2)	0.00018
LEF1: Cycle 1 Day 1, Baseline (n=55)	0.18940
LEF1: Cycle 1 Day 1, Post-dose (n=52)	0.14479
LEF1: Cycle 1 Day 15, 0 hours (n=48)	0.07819
LEF1: Cycle 1 Day 15, Post-dose (n=46)	0.05586
MCL1: Cycle 1 Day 1, Baseline (n=55)	0.42021
MCL1: Cycle 1 Day 1, Post-dose (n=52)	0.44770
MCL1: Cycle 1 Day 15, 0 hours (n=48)	0.52160
MCL1: Cycle 1 Day 15, Post-dose (n=46)	0.61933
MDC1: Cycle 1 Day 1, Baseline (n=55)	0.01825
MDC1: Cycle 1 Day 1, Post-dose (n=52)	0.01825
MDC1: Cycle 1 Day 15, 0 hours (n=48)	0.01109
MDC1: Cycle 1 Day 15, Post-dose (n=46)	0.01034
MRE11A: Cycle 1 Day 1, Baseline (n=55)	0.00708
MRE11A: Cycle 1 Day 1, Post-dose (n=52)	0.00672
MRE11A: Cycle 1 Day 15, 0 hours (n=48)	0.00484
MRE11A: Cycle 1 Day 15, Post-dose (n=46)	0.00508
MTOR: Cycle 1 Day 1, Baseline (n=55)	0.01585
MTOR: Cycle 1 Day 1, Post-dose (n=52)	0.01636
MTOR: Cycle 1 Day 15, 0 hours (n=48)	0.01088
MTOR: Cycle 1 Day 15, Post-dose (n=46)	0.01122
NHEJ1: Cycle 1 Day 1, Baseline (n=55)	0.01162
NHEJ1: Cycle 1 Day 1, Post-dose (n=52)	0.01164
NHEJ1: Cycle 1 Day 15, 0 hours (n=48)	0.00974
NHEJ1: Cycle 1 Day 15, Post-dose (n=46)	0.01008
NLRP2: Cycle 1 Day 1, Baseline (n=55)	0.00237
NLRP2: Cycle 1 Day 1, Post-dose (n=52)	0.00226
NLRP2: Cycle 1 Day 15, 0 hours (n=47)	0.00301
NLRP2: Cycle 1 Day 15, Post-dose (n=46)	0.00283
NOXA1: Cycle 1 Day 1, Baseline (n=52)	0.00097
NOXA1: Cycle 1 Day 1, Post-dose (n=48)	0.00107
NOXA1: Cycle 1 Day 15, 0 hours (n=43)	0.00132
NOXA1: Cycle 1 Day 15, Post-dose (n=42)	0.00117
PAX5: Cycle 1 Day 1, Baseline (n=55)	0.05536
PAX5: Cycle 1 Day 1, Post-dose (n=52)	0.04433
PAX5: Cycle 1 Day 15, 0 hours (n=30)	0.00511
PAX5: Cycle 1 Day 15, Post-dose (n=31)	0.00369
PDE4A: Cycle 1 Day 1, Baseline (n=55)	0.00738
PDE4A: Cycle 1 Day 1, Post-dose (n=52)	0.00722
PDE4A: Cycle 1 Day 15, 0 hours (n=48)	0.00916
PDE4A: Cycle 1 Day 15, Post-dose (n=46)	0.00836
PGK1: Cycle 1 Day 1, Baseline (n=55)	0.19043
PGK1: Cycle 1 Day 1, Post-dose (n=52)	0.18772
PGK1: Cycle 1 Day 15, 0 hours (n=48)	0.14989
PGK1: Cycle 1 Day 15, Post-dose (n=46)	0.14783
PIK3CA: Cycle 1 Day 1, Baseline (n=55)	0.01664
PIK3CA: Cycle 1 Day 1, Post-dose (n=52)	0.01714
PIK3CA: Cycle 1 Day 15, 0 hours (n=48)	0.01154
PIK3CA: Cycle 1 Day 15, Post-dose (n=46)	0.01164
PRKDC: Cycle 1 Day 1, Baseline (n=55)	0.03206
PRKDC: Cycle 1 Day 1, Post-dose (n=52)	0.03543
PRKDC: Cycle 1 Day 15, 0 hours (n=48)	0.01964
PRKDC: Cycle 1 Day 15, Post-dose (n=46)	0.02159
RAD50: Cycle 1 Day 1, Baseline (n=55)	0.01482
RAD50: Cycle 1 Day 1, Post-dose (n=52)	0.01516
RAD50: Cycle 1 Day 15, 0 hours (n=48)	0.01129
RAD50: Cycle 1 Day 15, Post-dose (n=46)	0.01044
RAD51: Cycle 1 Day 1, Baseline (n=54)	0.00558
RAD51: Cycle 1 Day 1, Post-dose (n=51)	0.00573
RAD51: Cycle 1 Day 15, 0 hours (n=47)	0.00382
RAD51: Cycle 1 Day 15, Post-dose (n=45)	0.00356
RAD52: Cycle 1 Day 1, Baseline (n=55)	0.00384
RAD52: Cycle 1 Day 1, Post-dose (n=52)	0.00330
RAD52: Cycle 1 Day 15, 0 hours (n=48)	0.00221
RAD52: Cycle 1 Day 15, Post-dose (n=46)	0.00211
RB1: Cycle 1 Day 1, Baseline (n=55)	0.03434
RB1: Cycle 1 Day 1, Post dose (n=52)	0.03384
RB1: Cycle 1 Day 15, 0 hours (n=48)	0.01926
RB1: Cycle 1 Day 15, Post-dose (n=46)	0.01978
RHEB: Cycle 1 Day 1, Baseline (n=55)	0.02719
RHEB: Cycle 1 Day 1, Post-dose (n=52)	0.02287
RHEB: Cycle 1 Day 15, 0 hours (n=48)	0.01810
RHEB: Cycle 1 Day 15, Post-dose (n=46)	0.01835
RPA1: Cycle 1 Day 1, Baseline (n=55)	0.05178
RPA1: Cycle 1 Day 1, Post-dose (n=52)	0.05041
RPA1: Cycle 1 Day 15, 0 hours (n=48)	0.05348
RPA1: Cycle 1 Day 15, Post-dose (n=46)	0.05547
SMAD1: Cycle 1 Day 1, Baseline (n=55)	0.00858
SMAD1: Cycle 1 Day 1, Post-dose (n=51)	0.01116
SMAD1: Cycle 1 Day 15, 0 hours (n=47)	0.00167
SMAD1: Cycle 1 Day 15, Post-dose (n=46)	0.00197
SYK: Cycle 1 Day 1, Baseline (n=55)	0.06101
SYK: Cycle 1 Day 1, Post-dose (n=52)	0.05995
SYK: Cycle 1 Day 15, 0 hours (n=48)	0.04237
SYK: Cycle 1 Day 15, Post-dose (n=46)	0.04603
TCF3: Cycle 1 Day 1, Baseline (n=55)	0.09144
TCF3: Cycle 1 Day 1, Post-dose (n=52)	0.07770
TCF3: Cycle 1 Day 15, 0 hours (n=48)	0.04216
TCF3: Cycle 1 Day 15, Post-dose (n=46)	0.05154
TNF: Cycle 1 Day 1, Baseline (n=55)	0.00465
TNF: Cycle 1 Day 1, Post-dose (n=52)	0.00330
TNF: Cycle 1 Day 15, 0 hours (n=48)	0.00376
TNF: Cycle 1 Day 15, Post-dose (n=46)	0.00262
TP53: Cycle 1 Day 1, Baseline (n=55)	0.05412
TP53: Cycle 1 Day 1, Post-dose (n=52)	0.04778
TP53: Cycle 1 Day 15, 0 hours (n=48)	0.03196
TP53: Cycle 1 Day 15, Post-dose (n=46)	0.02741
TP53BP1: Cycle 1 Day 1, Baseline (n=55)	0.00386
TP53BP1: Cycle 1 Day 1, Post-dose (n=52)	0.00373
TP53BP1: Cycle 1 Day 15, 0 hours (n=48)	0.00205
TP53BP1: Cycle 1 Day 15, Post-dose (n=46)	0.00182
VDAC3: Cycle 1 Day 1, Baseline (n=55)	0.03899
VDAC3: Cycle 1 Day 1, Post-dose (n=52)	0.03701
VDAC3: Cycle 1 Day 15, 0 hours (n=48)	0.03748
VDAC3: Cycle 1 Day 15, Post-dose (n=46)	0.03621
VPREB1: Cycle 1 Day 1, Baseline (n=52)	0.08210
VPREB1: Cycle 1 Day 1, Post-dose (n=47)	0.08593
VPREB1: Cycle 1 Day 15, 0 hours (n=25)	0.00472
VPREB1: Cycle 1 Day 15, Post-dose (n=28)	0.00332
XRCC2: Cycle 1 Day 1, Baseline (n=54)	0.00260
XRCC2: Cycle 1 Day 1, Post-dose (n=51)	0.00297
XRCC2: Cycle 1 Day 15, 0 hours (n=47)	0.00125
XRCC2: Cycle 1 Day 15, Post-dose (n=43)	0.00124
XRCC3: Cycle 1 Day 1, Baseline (n=55)	0.00213
XRCC3: Cycle 1 Day 1, Post-dose (n=50)	0.00205
XRCC3: Cycle 1 Day 15, 0 hours (n=46)	0.00110
XRCC3: Cycle 1 Day 15, Post-dose (n=43)	0.00103
XRCC4: Cycle 1 Day 1, Baseline (n=55)	0.00175
XRCC4: Cycle 1 Day 1, Post-dose (n=52)	0.00183
XRCC4: Cycle 1 Day 15, 0 hours (n=47)	0.00172
XRCC4: Cycle 1 Day 15, Post-dose (n=46)	0.00179
XRCC5: Cycle 1 Day 1, Baseline (n=55)	0.22952
XRCC5: Cycle 1 Day 15, 0 hours (n=48)	0.18735
XRCC5: Cycle 1 Day 15, Post-dose (n=46)	0.17577
XRCC6: Cycle 1 Day 1, Baseline (n=55)	0.07688
XRCC6: Cycle 1 Day 1, Post-dose (n=52)	0.06620
XRCC6: Cycle 1 Day 15, 0 hours (n=48)	0.04898
XRCC6: Cycle 1 Day 15, Post-dose (n=46)	0.04495
ZAP70: Cycle 1 Day 1, Baseline (n=55)	0.11022
ZAP70: Cycle 1 Day 1, Post-dose (n=52)	0.10939
ZAP70: Cycle 1 Day 15, 0 hours (n=48)	0.18066
ZAP70: Cycle 1 Day 15, Post-dose (n=46)	0.15080
XRCC5: Cycle 1 Day 1, Post-dose (n=52)	0.22401

Adverse Events

Time Frame	AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years.
Adverse Event Reporting Description	Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE & SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant & nonserious in another participant, or 1 participant may have experienced both a serious & nonserious event.
Arm/Group Title	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2		Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2		Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2		Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2		Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2
Arm/Group Description	IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles		IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles		IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles		IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles		IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
All Cause Mortality
	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2		Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2		Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2		Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2		Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2		Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2		Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2		Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2		Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		4/12 (33.3%)		8/9 (88.9%)		10/13 (76.9%)		26/35 (74.3%)
Blood and lymphatic system disorders
Febrile neutropenia	2/3 (66.7%)		0/12 (0%)		1/9 (11.1%)		5/13 (38.5%)		8/35 (22.9%)
Neutropenia	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		3/35 (8.6%)
Thrombocytopenia	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		2/35 (5.7%)
Ear and labyrinth disorders
Deafness	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Gastrointestinal disorders
Ascites	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		2/13 (15.4%)		1/35 (2.9%)
Colitis	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		1/35 (2.9%)
Constipation	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Diarrhoea	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Oral disorder	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Pancreatitis	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		1/13 (7.7%)		0/35 (0%)
Pancreatitis acute	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
General disorders
Disease progression	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		1/13 (7.7%)		3/35 (8.6%)
Pyrexia	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Hepatobiliary disorders
Cholangitis	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Cholecystitis	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Hyperbilirubinaemia	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Venoocclusive liver disease	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		3/35 (8.6%)
Infections and infestations
Abscess limb	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Bacteraemia	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Cellulitis	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Device related infection	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Enterococcal bacteraemia	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Necrotising fasciitis	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Periorbital cellulitis	1/3 (33.3%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Pneumonia	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		5/35 (14.3%)
Pneumonia fungal	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Pneumonia influenzal	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Septic shock	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Staphylococcal sepsis	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Stenotrophomonas sepsis	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Injury, poisoning and procedural complications
Subdural haematoma	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Investigations
Aspartate aminotransferase increased	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Metabolism and nutrition disorders
Dehydration	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Failure to thrive	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Hyponatraemia	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Tumour lysis syndrome	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		1/13 (7.7%)		0/35 (0%)
Back pain	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Bone pain	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Muscular weakness	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Pain in extremity	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Central nervous system neoplasm	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Nervous system disorders
Encephalopathy	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Headache	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Neurological symptom	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Neuropathy peripheral	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Presyncope	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Syncope	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Psychiatric disorders
Confusional state	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Mental status changes	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Renal and urinary disorders
Acute kidney injury	1/3 (33.3%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		1/35 (2.9%)
Pleural effusion	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Skin and subcutaneous tissue disorders
Rash	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Vascular disorders
Hypertension	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2		Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2		Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2		Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2		Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		12/12 (100%)		9/9 (100%)		10/13 (76.9%)		34/35 (97.1%)
Blood and lymphatic system disorders
Anaemia	1/3 (33.3%)		1/12 (8.3%)		3/9 (33.3%)		2/13 (15.4%)		13/35 (37.1%)
Febrile neutropenia	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		5/35 (14.3%)
Leukopenia	0/3 (0%)		0/12 (0%)		2/9 (22.2%)		0/13 (0%)		8/35 (22.9%)
Lymphopenia	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		1/13 (7.7%)		0/35 (0%)
Neutropenia	1/3 (33.3%)		2/12 (16.7%)		6/9 (66.7%)		3/13 (23.1%)		7/35 (20%)
Thrombocytopenia	2/3 (66.7%)		4/12 (33.3%)		5/9 (55.6%)		2/13 (15.4%)		19/35 (54.3%)
Lymph node pain	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Splenomegaly	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Cardiac disorders
Tachycardia	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		3/35 (8.6%)
Ear and labyrinth disorders
External ear pain	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Eye disorders
Conjunctival haemorrhage	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Vision blurred	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		2/35 (5.7%)
Gastrointestinal disorders
Abdominal distension	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		1/35 (2.9%)
Abdominal pain upper	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Constipation	0/3 (0%)		5/12 (41.7%)		1/9 (11.1%)		2/13 (15.4%)		8/35 (22.9%)
Diarrhoea	0/3 (0%)		0/12 (0%)		3/9 (33.3%)		0/13 (0%)		8/35 (22.9%)
Dry mouth	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Dysphagia	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		1/35 (2.9%)
Flatulence	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Gastrooesophageal reflux disease	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Gingival bleeding	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		1/13 (7.7%)		0/35 (0%)
Nausea	1/3 (33.3%)		5/12 (41.7%)		3/9 (33.3%)		4/13 (30.8%)		12/35 (34.3%)
Oral disorder	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Oral pain	0/3 (0%)		0/12 (0%)		2/9 (22.2%)		0/13 (0%)		1/35 (2.9%)
Retching	1/3 (33.3%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Vomiting	0/3 (0%)		4/12 (33.3%)		3/9 (33.3%)		2/13 (15.4%)		11/35 (31.4%)
Abdominal pain	1/3 (33.3%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		2/35 (5.7%)
Odynophagia	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
General disorders
Asthenia	1/3 (33.3%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Chest pain	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		1/35 (2.9%)
Chills	1/3 (33.3%)		0/12 (0%)		1/9 (11.1%)		1/13 (7.7%)		4/35 (11.4%)
Facial pain	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		1/35 (2.9%)
Fatigue	0/3 (0%)		6/12 (50%)		1/9 (11.1%)		1/13 (7.7%)		5/35 (14.3%)
Generalised oedema	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Malaise	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Mucosal haemorrhage	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Oedema	1/3 (33.3%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Oedema peripheral	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		3/35 (8.6%)
Pain	0/3 (0%)		1/12 (8.3%)		1/9 (11.1%)		0/13 (0%)		1/35 (2.9%)
Pyrexia	0/3 (0%)		1/12 (8.3%)		1/9 (11.1%)		2/13 (15.4%)		12/35 (34.3%)
Catheter site erythema	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Hepatobiliary disorders
Hyperbilirubinaemia	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		1/13 (7.7%)		9/35 (25.7%)
Infections and infestations
Candida infection	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		3/35 (8.6%)
Influenza	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Otitis externa	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Pseudomonal bacteraemia	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Pulmonary mycosis	1/3 (33.3%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Sepsis	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Septic shock	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Sinusitis fungal	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Upper respiratory tract infection	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		4/35 (11.4%)
Urinary tract infection	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		2/35 (5.7%)
Sinusitis	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Injury, poisoning and procedural complications
Ankle fracture	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Contusion	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		1/35 (2.9%)
Fall	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Foot fracture	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Infusion related reaction	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Post lumbar puncture syndrome	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Transplant failure	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Investigations
Activated partial thromboplastin time	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Alanine aminotransferase increased	0/3 (0%)		1/12 (8.3%)		1/9 (11.1%)		1/13 (7.7%)		6/35 (17.1%)
Aspartate aminotransferase increased	0/3 (0%)		3/12 (25%)		5/9 (55.6%)		3/13 (23.1%)		8/35 (22.9%)
Blood alkaline phosphatase increased	0/3 (0%)		0/12 (0%)		4/9 (44.4%)		1/13 (7.7%)		7/35 (20%)
Blood creatinine increased	1/3 (33.3%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Blood test abnormal	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Electrocardiogram QT prolonged	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Gamma-glutamyltransferase increased	2/3 (66.7%)		0/12 (0%)		5/9 (55.6%)		0/13 (0%)		3/35 (8.6%)
Lipase increased	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		1/35 (2.9%)
Neutrophil count decreased	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		3/35 (8.6%)
Weight increased	0/3 (0%)		0/12 (0%)		2/9 (22.2%)		0/13 (0%)		0/35 (0%)
Weight decreased	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Metabolism and nutrition disorders
Decreased appetite	1/3 (33.3%)		2/12 (16.7%)		2/9 (22.2%)		1/13 (7.7%)		3/35 (8.6%)
Hyperglycaemia	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		5/35 (14.3%)
Hyperuricaemia	1/3 (33.3%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		4/35 (11.4%)
Hypoalbuminaemia	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		6/35 (17.1%)
Hypocalcaemia	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		4/35 (11.4%)
Hypokalaemia	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		6/35 (17.1%)
Hypomagnesaemia	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		3/35 (8.6%)
Hyponatraemia	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		7/35 (20%)
Hypophosphataemia	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		3/35 (8.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/3 (33.3%)		0/12 (0%)		1/9 (11.1%)		1/13 (7.7%)		2/35 (5.7%)
Back pain	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		3/35 (8.6%)
Bone pain	0/3 (0%)		0/12 (0%)		0/9 (0%)		2/13 (15.4%)		0/35 (0%)
Musculoskeletal pain	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		3/35 (8.6%)
Myalgia	0/3 (0%)		0/12 (0%)		2/9 (22.2%)		1/13 (7.7%)		0/35 (0%)
Pain in extremity	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		3/35 (8.6%)
Tendonitis	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Nervous system disorders
Dizziness	1/3 (33.3%)		0/12 (0%)		1/9 (11.1%)		1/13 (7.7%)		2/35 (5.7%)
Dysgeusia	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Headache	0/3 (0%)		2/12 (16.7%)		1/9 (11.1%)		1/13 (7.7%)		8/35 (22.9%)
Nervous system disorder	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Neuropathy peripheral	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		3/35 (8.6%)
Paraesthesia	0/3 (0%)		0/12 (0%)		2/9 (22.2%)		0/13 (0%)		0/35 (0%)
Hypoaesthesia	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		1/35 (2.9%)
Tremor	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Psychiatric disorders
Anxiety	0/3 (0%)		0/12 (0%)		2/9 (22.2%)		0/13 (0%)		4/35 (11.4%)
Insomnia	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Renal and urinary disorders
Urinary retention	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Reproductive system and breast disorders
Testicular pain	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/3 (33.3%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		9/35 (25.7%)
Dyspnoea	1/3 (33.3%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		4/35 (11.4%)
Epistaxis	0/3 (0%)		0/12 (0%)		2/9 (22.2%)		1/13 (7.7%)		6/35 (17.1%)
Oropharyngeal pain	0/3 (0%)		1/12 (8.3%)		1/9 (11.1%)		0/13 (0%)		2/35 (5.7%)
Respiratory failure	0/3 (0%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Rhinitis allergic	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Rhinorrhoea	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		2/35 (5.7%)
Tachypnoea	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Dyspnoea exertional	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Tonsillar hypertrophy	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Wheezing	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Skin and subcutaneous tissue disorders
Erythema	0/3 (0%)		0/12 (0%)		2/9 (22.2%)		0/13 (0%)		1/35 (2.9%)
Pruritus	0/3 (0%)		1/12 (8.3%)		1/9 (11.1%)		1/13 (7.7%)		3/35 (8.6%)
Rash	1/3 (33.3%)		1/12 (8.3%)		1/9 (11.1%)		0/13 (0%)		3/35 (8.6%)
Rash erythematous	1/3 (33.3%)		0/12 (0%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Rash maculo-papular	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		1/35 (2.9%)
Rash morbilliform	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Rash pruritic	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Urticaria	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		0/35 (0%)
Hyperkeratosis	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Skin exfoliation	0/3 (0%)		1/12 (8.3%)		0/9 (0%)		0/13 (0%)		0/35 (0%)
Vascular disorders
Deep vein thrombosis	0/3 (0%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		0/35 (0%)
Hypertension	1/3 (33.3%)		0/12 (0%)		0/9 (0%)		1/13 (7.7%)		2/35 (5.7%)
Hypotension	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		5/35 (14.3%)
Phlebitis	0/3 (0%)		0/12 (0%)		1/9 (11.1%)		0/13 (0%)		1/35 (2.9%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI must remove any previously undisclosed Confidential Information (other than the Study results themselves) before public release.