An Investigational Immuno-therapy Study of Ulocuplumab in... | NCT02305563 | Trialant
NCT02305563
Sponsor
Bristol-Myers Squibb
Status
Terminated
Last Update Posted
Sep 16, 2021Actual
Enrollment
70Actual
Phase
Phase 1Phase 2
Conditions
Leukemia
Interventions
BMS-936564
Cytarabine
Countries
United States
Brazil
Canada
China
Israel
Italy
Japan
Romania
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02305563
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA212-016
Secondary IDs
Not provided
Brief Title
An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia
Official Title
A Phase 1/2, Open-label Randomized Study of Ulocuplumab (BMS-936564) in Combination With Low Dose Cytarabine in Subjects With Newly Diagnosed Acute Myeloid Leukemia
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Aug 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business objectives have changed, slow accrual, the standard of care for the patient population changed and we were unable to accrue any longer.
Expanded Access Info
No
Start Date
Jan 27, 2015Actual
Primary Completion Date
Jun 4, 2019Actual
Completion Date
Jun 4, 2019Actual
First Submitted Date
Nov 27, 2014
First Submission Date that Met QC Criteria
Nov 27, 2014
First Posted Date
Dec 2, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 3, 2020
Results First Submitted that Met QC Criteria
Aug 18, 2021
Results First Posted Date
Sep 16, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 18, 2021
Last Update Posted Date
Sep 16, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the safety and effectiveness of ulocuplumab in combination with low dose cytarabine in the treatment of Newly Diagnosed Acute Myeloid Leukemia (AML).
Low Dose Cytarabine only Phase 2 (expansion cohort)
Drug: BMS-936564
Drug: Cytarabine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-936564
Drug
Ulocuplumab + low dose Cytarabine
Ulocuplumab Dose A + low dose Cytarabine
Ulocuplumab Dose B + low dose Cytarabine
low dose Cytarabine only
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1
Safety data evaluated for DLTs. DLTs and all other toxicities were defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). DLTs were defined based upon events that were considered to be related to ulocuplumab in combination with LDAC and that occurred during the first cycle of drug administration (28 days).
From first dose to end of cycle 1 (28 days)
Number of Participants With Adverse Events (AEs) - Phase 1
The number of participants with an on-study adverse event (AE).
Safety data are evaluated for AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
From first dose to 30 days post last dose
Number of Participants With >= Grade 3 AEs - Phase 1
The number of participants with an on-study adverse event >= Grade level 3.
Safety data are evaluated for >= Grade 3 AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
From first dose to 30 days post last dose
Number of Participants With AEs Leading to Discontinuation - Phase 1
The number of participants with an on-study adverse event (AE) leading to discontinuation.
Safety data are evaluated for AEs leading to discontinuation, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
From first dose to 30 days post last dose
Number of Participants With Serious Adverse Events (SAEs) - Phase 1
The number of participants with an on-study serious adverse event (SAE).
Safety data are evaluated for SAEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Secondary Outcomes
Measure
Description
Time Frame
Best Overall Response (BOR) - Phase 1
Investigator assessed best overall response prior to the initiation of any alternative therapy for Phase 1 participants.
From first dose until a minimum follow-up of up to 2 months
Number of Participants With AEs - Phase 2
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Newly Diagnosed Acute Myeloid Leukemia (AML)
Considered inappropriate for intensive remission induction therapy by an investigator
Not eligible for stem cell transplantation
Exclusion Criteria:
Acute promyelocytic leukemia
Current Myelodysplastic syndrome only subjects
Unstable angina or uncontrolled congestive heart failure
Any other malignancy, excluding basal or squamous cell carcinoma of the skin, in situ melanoma, cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer stage 0, from which the subject has not been disease-free for at least 3 years
6 participants in Phase 1 and 64 participants in Phase 2 (70 in total) were assigned to treatment. 2 participants randomized to the LDAC-only arm in Phase 2 did not receive treatment. 68 participants in total (phases 1 and 2) were treated.
Number of Participants With Laboratory Abnormalities - Phase 1
The number of participants with an on-study laboratory abnormality.
Safety data are evaluated for laboratory abnormalities, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
grades 1, 2, 3, 4, 5, unknown, with 5 being the worst outcome
From first dose to 30 days post last dose
Best Overall Response (BOR) - Phase 2
The phase 2 primary endpoint was based on the rate of Complete Remission (CR/CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 primary analysis was conducted after all participants had an opportunity for 6 months of follow-up.
Complete remission rate: CR + CRi, confidence interval based on the Clopper and Pearson method.
From first dose until a minimum follow-up of up to 2 months
The number of participants with an on-study adverse event (AE).
Safety data are evaluated for AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
From first dose until a minimum follow-up of up to 2 months
Number of Participants With AEs Leading to Discontinuation - Phase 2
The number of participants with an on-study adverse event (AE) leading to discontinuation.
Safety data are evaluated for AEs leading to discontinuation, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
From first dose until a minimum follow-up of up to 2 months
Number of Participants With SAEs - Phase 2
The number of participants with an on-study serious adverse event (SAE).
Safety data are evaluated for SAEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
From first dose until a minimum follow-up of up to 2 months
Number of Deaths- Phase 2
The number of participants who died.
Safety data are evaluated for deaths, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
From first dose until a minimum follow-up of up to 2 months
Number of Participants With Laboratory Abnormalities - Phase 2
The number of participants with an on-study laboratory abnormality, assessed from Grade 1-4 Serum Chemistry, Electrolytes, and Hematology Laboratory Test results, with grade 4 being the worst.
Safety data are evaluated for laboratory abnormalities, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
From first dose until a minimum follow-up of up to 2 months
Number of Participants With Anti-drug Antibodies (ADA) Positive for Ulocuplumab - Phases 1 and 2
Serum samples from ulocuplumab treated participants were evaluated for the presence of anti-ulocuplumab antibodies
From first dose until a minimum follow-up of up to 2 months
Maximum Observed Serum Concentration (Cmax) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration
EOT = end of treatment
Measure type and method of dispersion are Geometric mean and %CV, respectively
Cycle 1 Day 1
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
Measure type and method of dispersion are Geometric mean and %CV, respectively
Days 1, 8, 15 for cycle 1; Days 8, 15 for cycle 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Time of Maximum Observed Ulocuplumab Serum Concentration (Tmax) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
Cycle 1 Day 1
Area Under the Ulocuplumab Concentration-time Curve From Time Zero to the Last Quantifiable Concentration [AUC(0-T)] - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
AUC(0-T) calculated by log- and linear-trapezoidal summation
Measure type and method of dispersion are Geometric mean and %CV, respectively
Cycle 1 Day 1
Area Under the Ulocuplumab Concentration-time Curve in One Dosing Interval [AUC(TAU)] - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
Measure type and method of dispersion are Geometric mean and %CV, respectively
Cycle 1 Day 1
Area Under the Ulocuplumab Concentration-time Curve From Time Zero to Infinity [AUC(INF)] - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
AUC(INF) calculated by summing AUC(0-T) and the extrapolated area, computed by the quotient Clast/λz
Measure type and method of dispersion are Geometric mean and %CV, respectively
Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Elimination Half-life (T-HALF) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
T-HALF determined as 0.693/λz
Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Total Body Clearance of Ulocuplumab (CLT) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
CLT calculated by dividing the total dose of ulocuplumab by its corresponding AUC(INF) value
Measure type and method of dispersion are Geometric mean and %CV, respectively
Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Volume of Distribution at Steady State (Vss) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
Measure type and method of dispersion are Geometric mean and %CV, respectively
Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Overall Rate of Remission in Participants Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2
This phase 2 secondary endpoint was based on the rate of Overall Remission (OR=PR+CR +CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
Overall remission rate: CR + CRi, + PR confidence interval based on the Clopper and Pearson method.
From first dose until a minimum follow-up of up to 2 months
Duration of Response in Participants With CR/CRi Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2
This phase 2 secondary endpoint was based on the duration of complete remission prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
From first dose until a minimum follow-up of up to 2 months
Rate of Complete Remission (CR/CRi) and Overall Rate of Remission in Participants Treated With LDAC Only - Phase 2
This phase 2 secondary endpoint was based on the rate of Complete Remission (CR/CRi) and rate of Overall Remission (OR=PR+CR +CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
Overall remission rate: CR + CRi, + PR confidence interval based on the Clopper and Pearson method.
From first dose until a minimum follow-up of up to 2 months
Duration of Response in Participants With CR/CRi Treated With LDAC Only - Phase 2
This phase 2 secondary endpoint was based on the duration of complete remission prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Change from baseline of ECG endpoints
Heart rate measured in beats per minute (bpm)
From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Change from baseline of ECG endpoints
PR interval measured in milliseconds (msec)
From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Change from baseline of ECG endpoints
QRS interval measured in milliseconds (msec)
From first dose until a minimum follow-up of up to 2 months
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Change from baseline of ECG endpoints
QT interval measured in milliseconds (msec)
From first dose until a minimum follow-up of up to 2 months
Overall Survival (OS) - Phases 1 and 2
OS is defined as the time between the first date of treatment and the date of death due to any cause. A participant who has not died was be censored at the last known alive date.
From first dose until a minimum follow-up of up to 2 months
Orlando
Florida
32806
United States
Norton Cancer Institute
Louisville
Kentucky
40207
United States
NYU Langone Medical Center
New York
New York
10016
United States
Duke University Adult Bone Marrow Transplant Clinic
Durham
North Carolina
27705
United States
University Of Cincinnati
Cincinnati
Ohio
45219
United States
Cleveland Clinic Taussig Cancer Center
Cleveland
Ohio
44195
United States
The University Of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Froedtert Hospital & Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
Liga Paranaense De Combate Ao Cancer Erasto Gaertner
Curitiba
Paraná
81520-060
Brazil
Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
FG0003 subjects
FG0013 subjects
FG00226 subjects
FG00314 subjects
FG00424 subjects
COMPLETED
Completed = Continuing in the treatment period
FG0001 subjectsAt the time of the Phase 1 lock, 1 participant was still continuing on treatment
FG0011 subjectsAt the time of the Phase 1 lock, 1 participant was still continuing on treatment
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG00226
BG00314
BG00424
BG00570
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG0003
ParticipantsBG0013
ParticipantsBG00226
ParticipantsBG003
Age, Customized
Age categorical
Number
Participants
Title
Denominators
Categories
<70
ParticipantsBG0003
ParticipantsBG0013
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0003
ParticipantsBG0013
ParticipantsBG002
Ethnicity (NIH/OMB)
data not collected
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Race/Ethnicity, Customized
Race
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0003
ParticipantsBG0013
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1
Safety data evaluated for DLTs. DLTs and all other toxicities were defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). DLTs were defined based upon events that were considered to be related to ulocuplumab in combination with LDAC and that occurred during the first cycle of drug administration (28 days).
Number of Participants With Adverse Events (AEs) - Phase 1
The number of participants with an on-study adverse event (AE).
Safety data are evaluated for AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Number of Participants With >= Grade 3 AEs - Phase 1
The number of participants with an on-study adverse event >= Grade level 3.
Safety data are evaluated for >= Grade 3 AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Number of Participants With AEs Leading to Discontinuation - Phase 1
The number of participants with an on-study adverse event (AE) leading to discontinuation.
Safety data are evaluated for AEs leading to discontinuation, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Number of Participants With Serious Adverse Events (SAEs) - Phase 1
The number of participants with an on-study serious adverse event (SAE).
Safety data are evaluated for SAEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
Number of Participants With Laboratory Abnormalities - Phase 1
The number of participants with an on-study laboratory abnormality.
Safety data are evaluated for laboratory abnormalities, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
grades 1, 2, 3, 4, 5, unknown, with 5 being the worst outcome
The phase 2 primary endpoint was based on the rate of Complete Remission (CR/CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 primary analysis was conducted after all participants had an opportunity for 6 months of follow-up.
Complete remission rate: CR + CRi, confidence interval based on the Clopper and Pearson method.
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Secondary
Best Overall Response (BOR) - Phase 1
Investigator assessed best overall response prior to the initiation of any alternative therapy for Phase 1 participants.
All randomized participants
Posted
Number
Participants
From first dose until a minimum follow-up of up to 2 months
The number of participants with an on-study adverse event (AE).
Safety data are evaluated for AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
All treated participants
Posted
Number
Participants
From first dose until a minimum follow-up of up to 2 months
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Secondary
Number of Participants With AEs Leading to Discontinuation - Phase 2
The number of participants with an on-study adverse event (AE) leading to discontinuation.
Safety data are evaluated for AEs leading to discontinuation, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
All treated participants
Posted
Number
Participants
From first dose until a minimum follow-up of up to 2 months
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Secondary
Number of Participants With SAEs - Phase 2
The number of participants with an on-study serious adverse event (SAE).
Safety data are evaluated for SAEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
All treated participants
Posted
Number
Participants
From first dose until a minimum follow-up of up to 2 months
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Secondary
Number of Deaths- Phase 2
The number of participants who died.
Safety data are evaluated for deaths, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
All treated participants
Posted
Number
Participants
From first dose until a minimum follow-up of up to 2 months
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Secondary
Number of Participants With Laboratory Abnormalities - Phase 2
The number of participants with an on-study laboratory abnormality, assessed from Grade 1-4 Serum Chemistry, Electrolytes, and Hematology Laboratory Test results, with grade 4 being the worst.
Safety data are evaluated for laboratory abnormalities, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
All treated participants
Posted
Number
Participants
From first dose until a minimum follow-up of up to 2 months
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Secondary
Number of Participants With Anti-drug Antibodies (ADA) Positive for Ulocuplumab - Phases 1 and 2
Serum samples from ulocuplumab treated participants were evaluated for the presence of anti-ulocuplumab antibodies
All participants treated with ulocuplumab
Posted
Number
Participants
From first dose until a minimum follow-up of up to 2 months
Area Under the Ulocuplumab Concentration-time Curve From Time Zero to Infinity [AUC(INF)] - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
AUC(INF) calculated by summing AUC(0-T) and the extrapolated area, computed by the quotient Clast/λz
Measure type and method of dispersion are Geometric mean and %CV, respectively
Based on the PK sample collections, PK parameters depended on terminal phase time points including AUC(INF), T-HALF; or at steady-state, including CLT, Vss are not reportable
Posted
Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
T-HALF determined as 0.693/λz
Based on the PK sample collections, PK parameters depended on terminal phase time points including AUC(INF), T-HALF; or at steady-state, including CLT, Vss are not reportable
Posted
Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Total Body Clearance of Ulocuplumab (CLT) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
CLT calculated by dividing the total dose of ulocuplumab by its corresponding AUC(INF) value
Measure type and method of dispersion are Geometric mean and %CV, respectively
Based on the PK sample collections, PK parameters depended on terminal phase time points including AUC(INF), T-HALF; or at steady-state, including CLT, Vss are not reportable
Posted
Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Volume of Distribution at Steady State (Vss) - Phases 1 and 2
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration.
EOT = end of treatment
Measure type and method of dispersion are Geometric mean and %CV, respectively
Based on the PK sample collections, PK parameters depended on terminal phase time points including AUC(INF), T-HALF; or at steady-state, including CLT, Vss are not reportable
Posted
Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)
Overall Rate of Remission in Participants Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2
This phase 2 secondary endpoint was based on the rate of Overall Remission (OR=PR+CR +CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
Overall remission rate: CR + CRi, + PR confidence interval based on the Clopper and Pearson method.
Duration of Response in Participants With CR/CRi Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2
This phase 2 secondary endpoint was based on the duration of complete remission prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
All randomized participants with CR/CRi
Posted
Median
Full Range
Months
From first dose until a minimum follow-up of up to 2 months
Rate of Complete Remission (CR/CRi) and Overall Rate of Remission in Participants Treated With LDAC Only - Phase 2
This phase 2 secondary endpoint was based on the rate of Complete Remission (CR/CRi) and rate of Overall Remission (OR=PR+CR +CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
Overall remission rate: CR + CRi, + PR confidence interval based on the Clopper and Pearson method.
From first dose until a minimum follow-up of up to 2 months
ID
Title
Description
OG000
LDAC - Ph2
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
Secondary
Duration of Response in Participants With CR/CRi Treated With LDAC Only - Phase 2
This phase 2 secondary endpoint was based on the duration of complete remission prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
All randomized participants with CR/CRi
Posted
Median
Full Range
Months
From first dose until a minimum follow-up of up to 2 months
ID
Title
Description
OG000
LDAC - Ph2
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG000
Secondary
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Change from baseline of ECG endpoints
Heart rate measured in beats per minute (bpm)
All treated participants
Posted
Mean
Standard Deviation
change from baseline bpm
From first dose until a minimum follow-up of up to 2 months
OS is defined as the time between the first date of treatment and the date of death due to any cause. A participant who has not died was be censored at the last known alive date.
All treated participants for phase 2. Phase 1 OS data not collected.
Posted
Median
Full Range
Months
From first dose until a minimum follow-up of up to 2 months
Includes on-treatment events from first dose to within 100 days of last dose
Description
At the end of the randomized treatment period, 6 participants in the LDAC only arm proceeded to treatment with added ulocuplumab. All 6 of the participants who added ulocuplumab following completion of LDAC only treatment have discontinued treatment. The safety data for these 6 participants are represented in the LDAC arm below.
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission.
16
22
15
22
22
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG0030 affected14 at risk
EG0041 affected22 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0028 affected26 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Cardiac disorder
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Cataract
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected26 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected26 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Complication associated with device
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Death
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected26 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0023 affected26 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0023 affected26 at risk
EG003
Septic shock
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Skin infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Amylase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected26 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected26 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG0003
OG0013
OG00217
OG00314
OG0041
Title
Denominators
Categories
Title
Measurements
OG000219.354± 19
OG001265.294± 8
OG002183.456± 25
OG003256.906± 22
OG004212.564± NANot applicable as n=1
OG004
LDAC - Ph2
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG0003
OG0013
OG00222
OG00313
OG0041
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00220
ParticipantsOG0038
ParticipantsOG0041
Title
Measurements
OG0000.100± 0
OG0010.100± 0
OG0020.100± 0
OG003
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00222
ParticipantsOG00313
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00219
ParticipantsOG00311
Cycle 2 Day 8
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG00310
Cycle 2 Day 15
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0038
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG00212
ParticipantsOG0033
Cycle 3 Day 8
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0033
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0031
Cycle 4 Day 8
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0032
Cycle 5 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Cycle 5 Day 8
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0031
Cycle 9 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
EOT
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG0003
OG0013
OG00217
OG0037
OG0041
Title
Denominators
Categories
Title
Measurements
OG0001.850(1.47 to 2.02)
OG0011.933(1.68 to 2.03)
OG0021.500(1.00 to 4.50)
OG0032.117(1.28 to 5.12)
OG0042.03(2.03 to 2.03)
OG004
LDAC - Ph2
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG0003
OG0013
OG00217
OG0037
OG0041
Title
Denominators
Categories
Title
Measurements
OG0009455.529± 10
OG00121158.725± 9
OG0028152.698± 50
OG00313744.382± 37
OG00416502.463± NANot applicable as n=1
OG004
LDAC - Ph2
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG004
LDAC - Ph2
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG004
LDAC - Ph2
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG00026
OG00114
Title
Denominators
Categories
Title
Measurements
OG00019.2(6.6 to 39.4)
OG0017.1(0.2 to 33.9)
4
OG0011
Title
Denominators
Categories
Title
Measurements
OG0002.4(0.5 to 5.6)
OG0014.3(NA to NA)Only 1 participant
OG00024
Title
Denominators
Categories
CR/CRi
Title
Measurements
OG00025.0(9.8 to 46.7)
Overall remission rate
Title
Measurements
OG00025.0(9.8 to 46.7)
6
Title
Denominators
Categories
Title
Measurements
OG0005.7(0.9 to NA)upper limit not reached
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG0003
OG0013
OG00215
OG00313
OG0049
Title
Denominators
Categories
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG00215
ParticipantsOG00313
ParticipantsOG0049
Title
Measurements
OG00026.0± 63.6
OG0014.0± 18.4
OG0021.8± 11.3
OG003
Cycle 3, Day 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG00213
ParticipantsOG0036
Cycle 4, Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0029
ParticipantsOG0033
Cycle 5, Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0032
Cycle 6, Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0030
Cycle 7, Day 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0031
Cycle 8, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0031
Cycle 9, Day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0031
Cycle 10, Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0030
Cycle 11, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Cycle 12, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Cycle 13, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 14, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 15, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 16, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG0003
OG0013
OG00215
OG00310
OG0049
Title
Denominators
Categories
Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG00215
ParticipantsOG00310
ParticipantsOG0049
Title
Measurements
OG0004.0± NANot applicable as n=1
OG001-14.0± 19.8
OG0021.1± 23.9
OG003
Cycle 3, Day 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG00212
ParticipantsOG0035
Cycle 4, Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0031
Cycle 5, Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0032
Cycle 6, Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0030
Cycle 7, Day 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0031
Cycle 8, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0031
Cycle 9, Day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0031
Cycle 10, Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0030
Cycle 11, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Cycle 12, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Cycle 13, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 14, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 15, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 16, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG0003
OG0013
OG00215
OG00313
OG0049
Title
Denominators
Categories
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG00215
ParticipantsOG00313
ParticipantsOG0049
Title
Measurements
OG0000.0± 5.7
OG001-2.0± 5.7
OG0025.1± 11.3
OG003
Cycle 3, Day 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG00213
ParticipantsOG0036
Cycle 4, Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0029
ParticipantsOG0033
Cycle 5, Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0032
Cycle 6, Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0030
Cycle 7, Day 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0031
Cycle 8, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0031
Cycle 9, Day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0031
Cycle 10, Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0030
Cycle 11, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Cycle 12, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Cycle 13, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 14, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 15, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 16, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission
Units
Counts
Participants
OG0003
OG0013
OG00215
OG00313
OG0049
Title
Denominators
Categories
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG00215
ParticipantsOG00313
ParticipantsOG0049
Title
Measurements
OG000-41.0± 94.8
OG001-5.0± 7.1
OG0024.5± 25.5
OG003
Cycle 3, Day 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG00213
ParticipantsOG0036
Cycle 4, Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0029
ParticipantsOG0033
Cycle 5, Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0032
Cycle 6, Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0030
Cycle 7, Day 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0031
Cycle 8, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0031
Cycle 9, Day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0031
Cycle 10, Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0030
Cycle 11, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Cycle 12, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Cycle 13, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 14, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 15, Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 16, Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
LDAC - Ph2
Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission