An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Terminated

CT.gov ID

NCT02305563

Collaborator

(none)

Enrollment

Locations

Arms

52.2

Actual Duration (Months)

1.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: BMS-936564 Drug: Cytarabine	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 27, 2015

Actual Primary Completion Date :

Jun 4, 2019

Actual Study Completion Date :

Jun 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ulocuplumab + low dose Cytarabine Ulocuplumab + low dose Cytarabine (LDAC) Phase 1 (escalation cohort) - closed for enrollment	Drug: BMS-936564 Other Names: Ulocuplumab MDX-1338 Drug: Cytarabine
Experimental: Ulocuplumab Dose A + low dose Cytarabine Ulocuplumab Dose A + low dose Cytarabine Phase 2 (expansion cohort)	Drug: BMS-936564 Other Names: Ulocuplumab MDX-1338 Drug: Cytarabine
Experimental: Ulocuplumab Dose B + low dose Cytarabine Ulocuplumab Dose B + low dose Cytarabine Phase 2 (expansion cohort)	Drug: BMS-936564 Other Names: Ulocuplumab MDX-1338 Drug: Cytarabine
Other: low dose Cytarabine only Low Dose Cytarabine only Phase 2 (expansion cohort)	Drug: BMS-936564 Other Names: Ulocuplumab MDX-1338 Drug: Cytarabine

Outcome Measures

Primary Outcome Measures

Number of Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1 [From first dose to end of cycle 1 (28 days)]
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 [From first dose to 30 days post last dose]
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 [From first dose to 30 days post last dose]
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 [From first dose to 30 days post last dose]
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 [From first dose to 30 days post last dose]
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 Deaths - Phase 1 [From first dose to 30 days post last dose]
The number of participants who died.
Number of Participants With Laboratory Abnormalities - Phase 1 [From first dose to 30 days post last dose]
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
Best Overall Response (BOR) - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
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. CR = complete response CRi = complete response, incomplete blood count

Secondary Outcome Measures

Best Overall Response (BOR) - Phase 1 [From first dose until a minimum follow-up of up to 2 months]
Investigator assessed best overall response prior to the initiation of any alternative therapy for Phase 1 participants.
Number of Participants With AEs - Phase 2 [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).
Number of Participants With AEs Leading to Discontinuation - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
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 SAEs - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
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 Deaths- Phase 2 [From first dose until a minimum follow-up of up to 2 months]
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).
Number of Participants With Laboratory Abnormalities - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
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).
Number of Participants With Anti-drug Antibodies (ADA) Positive for Ulocuplumab - Phases 1 and 2 [From first dose until a minimum follow-up of up to 2 months]
Serum samples from ulocuplumab treated participants were evaluated for the presence of anti-ulocuplumab antibodies
Maximum Observed Serum Concentration (Cmax) - Phases 1 and 2 [Cycle 1 Day 1]
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
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2 [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)]
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
Time of Maximum Observed Ulocuplumab Serum Concentration (Tmax) - Phases 1 and 2 [Cycle 1 Day 1]
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment
Area Under the Ulocuplumab Concentration-time Curve From Time Zero to the Last Quantifiable Concentration [AUC(0-T)] - Phases 1 and 2 [Cycle 1 Day 1]
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
Area Under the Ulocuplumab Concentration-time Curve in One Dosing Interval [AUC(TAU)] - Phases 1 and 2 [Cycle 1 Day 1]
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
Area Under the Ulocuplumab Concentration-time Curve From Time Zero to Infinity [AUC(INF)] - Phases 1 and 2 [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 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
Elimination Half-life (T-HALF) - Phases 1 and 2 [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
Total Body Clearance of Ulocuplumab (CLT) - Phases 1 and 2 [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 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
Volume of Distribution at Steady State (Vss) - Phases 1 and 2 [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 Measure type and method of dispersion are Geometric mean and %CV, respectively
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 [From first dose until a minimum follow-up of up to 2 months]
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. CR = complete response CRi = complete response, incomplete blood count PR = partial remission
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 [From first dose until a minimum follow-up of up to 2 months]
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.
Rate of Complete Remission (CR/CRi) and Overall Rate of Remission in Participants Treated With LDAC Only - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
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. CR = complete response CRi = complete response, incomplete blood count PR = partial remission
Duration of Response in Participants With CR/CRi Treated With LDAC Only - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
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.
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2 [From first dose until a minimum follow-up of up to 2 months]
Change from baseline of ECG endpoints Heart rate measured in beats per minute (bpm)
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2 [From first dose until a minimum follow-up of up to 2 months]
Change from baseline of ECG endpoints PR interval measured in milliseconds (msec)
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2 [From first dose until a minimum follow-up of up to 2 months]
Change from baseline of ECG endpoints QRS interval measured in milliseconds (msec)
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2 [From first dose until a minimum follow-up of up to 2 months]
Change from baseline of ECG endpoints QT interval measured in milliseconds (msec)
Overall Survival (OS) - Phases 1 and 2 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Respiratory disease requiring continuous supplemental oxygen

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ucla Center Health Sci	Los Angeles	California	United States	90095-3075
2	UF Health Cancer Center at Orlando Health	Orlando	Florida	United States	32806
3	Norton Cancer Institute	Louisville	Kentucky	United States	40207
4	NYU Langone Medical Center	New York	New York	United States	10016
5	Duke University Adult Bone Marrow Transplant Clinic	Durham	North Carolina	United States	27705
6	University Of Cincinnati	Cincinnati	Ohio	United States	45219
7	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
8	The University Of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
9	Froedtert Hospital & Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
10	Liga Paranaense De Combate Ao Cancer Erasto Gaertner	Curitiba	Parana	Brazil	81520-060
11	Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus	Porto Alegre	RIO Grande DO SUL	Brazil	90110-270
12	Fundacao Pio Xii Hosp Cancer De Barretos	Barretos	Sao Paulo	Brazil	14784-400
13	IEP Sao Lucas	Sao Paulo		Brazil	01236-030
14	Local Institution	Sao Paulo		Brazil	01246-000
15	Local Institution	Sao Paulo		Brazil	05651-901
16	Local Institution	Halifax	Nova Scotia	Canada	B3H 2Y9
17	Local Institution	Hong Kong		China
18	Local Institution	Jerusalem		Israel	91031
19	Local Institution	Tel Aviv		Israel	94239
20	Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele	Catania		Italy	95123
21	Local Institution	Milan		Italy	20162
22	Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli	Napoli		Italy	80131
23	Local Institution	Roma		Italy	00133
24	Local Institution	Nagoya-shi	Aichi	Japan	4600001
25	Local Institution	Fukuyama-shi	Hiroshima	Japan	7200001
26	Local Institution	Isehara	Kanagawa	Japan	2591193
27	Local Institution	Hirakata-shi	Osaka	Japan	5731191
28	Local Institution	Bunkyo-ku	Tokyo	Japan	1138677
29	Local Institution	Shinagawa-ku	Tokyo	Japan	1418625
30	Local Institution	Shinjuku-Ku	Tokyo	Japan	1608582
31	Local Institution	Tachikawa	Tokyo	Japan	1900014
32	Local Institution	Seoul		Korea, Republic of	06351
33	Local Institution	Seoul		Korea, Republic of	06591
34	Local Institution	Bucharest		Romania	020125
35	Local Institution	Kaohsiung		Taiwan	833
36	Local Institution	New Taipei City		Taiwan	235
37	Local Institution	New Taipei City		Taiwan	25173
38	Local Institution	Taoyuan City		Taiwan	33305

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT02305563

Other Study ID Numbers:

CA212-016

First Posted:

Dec 2, 2014

Last Update Posted:

Sep 16, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid, Acute

Cytarabine

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	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.

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Period Title: Treatment Period
STARTED	3	3	26	14	24
COMPLETED	1	1	0	0	0
NOT COMPLETED	2	2	26	14	24
Period Title: Treatment Period
STARTED	3	3	11	6	12
COMPLETED	0	0	0	0	0
NOT COMPLETED	3	3	11	6	12

Baseline Characteristics

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2	Total
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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	Total of all reporting groups
Overall Participants	3	3	26	14	24	70
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	73.7 (8.02)	77.3 (1.53)	74.9 (5.4)	73.1 (3.7)	75.9 (5.7)	74.9 (5.21)
Age, Customized (Number) [Number]
<70	1 33.3%	0 0%	4 15.4%	3 21.4%	3 12.5%	11 15.7%
>=70	2 66.7%	3 100%	22 84.6%	11 78.6%	21 87.5%	59 84.3%
Sex: Female, Male (Count of Participants)
Female	3 100%	0 0%	9 34.6%	7 50%	14 58.3%	33 47.1%
Male	0 0%	3 100%	17 65.4%	7 50%	10 41.7%	37 52.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	0 0%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	0 0%	0 0%	15 57.7%	4 28.6%	12 50%	31 44.3%
Black/African American	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Japanese	3 100%	3 100%	6 23.1%	6 42.9%	4 16.7%	22 31.4%
Chinese	0 0%	0 0%	2 7.7%	2 14.3%	3 12.5%	7 10%
Asian Indian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian Other	0 0%	0 0%	3 11.5%	0 0%	2 8.3%	5 7.1%
American Indian/Alaskan Native	0 0%	0 0%	0 0%	1 7.1%	0 0%	1 1.4%
Native Hawaiian/Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Other	0 0%	0 0%	0 0%	1 7.1%	3 12.5%	4 5.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1
Description	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).
Time Frame	From first dose to end of cycle 1 (28 days)

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
Measure Participants	3	3
Number [Participants]	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) - Phase 1
Description	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).
Time Frame	From first dose to 30 days post last dose

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
Measure Participants	3	3
Number [Participants]	3 100%	3 100%

3. Primary Outcome

Title	Number of Participants With >= Grade 3 AEs - Phase 1
Description	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).
Time Frame	From first dose to 30 days post last dose

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
Measure Participants	3	3
Number [Participants]	3 100%	3 100%

4. Primary Outcome

Title	Number of Participants With AEs Leading to Discontinuation - Phase 1
Description	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).
Time Frame	From first dose to 30 days post last dose

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
Measure Participants	3	3
Number [Participants]	0 0%	0 0%

5. Primary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs) - Phase 1
Description	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).
Time Frame	From first dose to 30 days post last dose

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
Measure Participants	3	3
Number [Participants]	2 66.7%	1 33.3%

6. Primary Outcome

Title	Number of Deaths - Phase 1
Description	The number of participants who died.
Time Frame	From first dose to 30 days post last dose

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
Measure Participants	3	3
Number [Participants]	0 0%	0 0%

7. Primary Outcome

Title	Number of Participants With Laboratory Abnormalities - Phase 1
Description	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
Time Frame	From first dose to 30 days post last dose

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
Measure Participants	3	3
ABSOLUTE NEUTROPHIL COUNT - grade 3	0 0%	1 33.3%
ABSOLUTE NEUTROPHIL COUNT - grade 4	3 100%	2 66.7%
ALANINE AMINOTRANSFERASE - grade 0	2 66.7%	2 66.7%
ALANINE AMINOTRANSFERASE - grade 1	1 33.3%	1 33.3%
ALBUMIN - grade 0	1 33.3%	0 0%
ALBUMIN - grade 1	0 0%	2 66.7%
ALBUMIN - grade 2	2 66.7%	1 33.3%
ALKALINE PHOSPHATASE - grade 0	2 66.7%	2 66.7%
ALKALINE PHOSPHATASE grade 1	1 33.3%	1 33.3%
ASPARTATE AMINOTRANSFERASE - grade 0	3 100%	2 66.7%
ASPARTATE AMINOTRANSFERASE - grade 1	0 0%	1 33.3%
BILIRUBIN, TOTAL - grade 0	3 100%	2 66.7%
BILIRUBIN, TOTAL - grade 2	0 0%	1 33.3%
CALCIUM, TOTAL - grade 0	1 33.3%	1 33.3%
CALCIUM, TOTAL - grade 1	0 0%	1 33.3%
CALCIUM, TOTAL - grade 2	2 66.7%	1 33.3%
CREATINE KINASE - grade 0	3 100%	3 100%
CREATININE - grade 0	2 66.7%	3 100%
CREATININE - grade 1	1 33.3%	0 0%
FIBRINOGEN - grade 0	1 33.3%	0 0%
GLUCOSE, FASTING SERUM - grade 0	1 33.3%	1 33.3%
GLUCOSE, FASTING SERUM - grade 1	2 66.7%	0 0%
GLUCOSE, FASTING SERUM - grade 2	0 0%	2 66.7%
HEMOGLOBIN - grade 2	1 33.3%	1 33.3%
HEMOGLOBIN - grade 3	2 66.7%	2 66.7%
LEUKOCYTES - grade 0	0 0%	1 33.3%
LEUKOCYTES - grade 3	1 33.3%	1 33.3%
LEUKOCYTES - grade 4	2 66.7%	1 33.3%
LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 0	2 66.7%	1 33.3%
LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 1	1 33.3%	0 0%
LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 3	0 0%	2 66.7%
LYMPHOCYTES (ABSOLUTE) - grade 0	0 0%	1 33.3%
LYMPHOCYTES (ABSOLUTE) - grade 1	0 0%	1 33.3%
LYMPHOCYTES (ABSOLUTE) - grade 2	2 66.7%	1 33.3%
LYMPHOCYTES (ABSOLUTE) - grade 3	1 33.3%	0 0%
NEUTROPHILS (ABSOLUTE) - grade 3	0 0%	1 33.3%
NEUTROPHILS (ABSOLUTE) - grade 4	3 100%	2 66.7%
PHOSPHORUS, INORGANIC - grade 0	3 100%	2 66.7%
PHOSPHORUS, INORGANIC - grade 3	0 0%	1 33.3%
PLATELET COUNT - grade 3	0 0%	1 33.3%
PLATELET COUNT - grade 4	3 100%	2 66.7%
POTASSIUM, SERUM - grade 0	1 33.3%	2 66.7%
POTASSIUM, SERUM - grade 1	0 0%	1 33.3%
POTASSIUM, SERUM - grade 3	2 66.7%	0 0%
SODIUM, SERUM - grade 0	2 66.7%	1 33.3%
SODIUM, SERUM - grade 1	0 0%	2 66.7%
SODIUM, SERUM - grade 3	1 33.3%	0 0%
URIC ACID - grade 0	3 100%	2 66.7%
URIC ACID - grade 1	0 0%	1 33.3%

8. Primary Outcome

Title	Best Overall Response (BOR) - Phase 2
Description	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. CR = complete response CRi = complete response, incomplete blood count
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All randomized participants

Arm/Group Title	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	26	14	24
Number (95% Confidence Interval) [Percentage of participants]	15.4 513.3%	7.1 236.7%	25.0 96.2%

9. Secondary Outcome

Title	Best Overall Response (BOR) - Phase 1
Description	Investigator assessed best overall response prior to the initiation of any alternative therapy for Phase 1 participants.
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All randomized participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
Measure Participants	3	3
Number [Participants]	1 33.3%	3 100%

10. Secondary Outcome

Title	Number of Participants With AEs - Phase 2
Description	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).
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	26	14	22
Number [Participants]	25 833.3%	14 466.7%	22 84.6%

11. Secondary Outcome

Title	Number of Participants With AEs Leading to Discontinuation - Phase 2
Description	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).
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	26	14	22
Number [Participants]	7 233.3%	3 100%	4 15.4%

12. Secondary Outcome

Title	Number of Participants With SAEs - Phase 2
Description	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).
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	26	14	22
Number [Participants]	21 700%	8 266.7%	15 57.7%

13. Secondary Outcome

Title	Number of Deaths- Phase 2
Description	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).
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	26	14	22
Number [Participants]	19 633.3%	10 333.3%	16 61.5%

14. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities - Phase 2
Description	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).
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	26	14	22
ALANINE AMINOTRANSFERASE (ALT), grade 1	5 166.7%	5 166.7%	4 15.4%
ALANINE AMINOTRANSFERASE (ALT), grade 2	0 0%	1 33.3%	2 7.7%
ALANINE AMINOTRANSFERASE (ALT), grade 3	2 66.7%	2 66.7%	0 0%
ALKALINE PHOSPHATASE (ALP), grade 1	9 300%	3 100%	8 30.8%
ALKALINE PHOSPHATASE (ALP), grade 2	1 33.3%	5 166.7%	2 7.7%
ASPARTATE AMINOTRANSFERASE (AST), grade 1	7 233.3%	8 266.7%	4 15.4%
ASPARTATE AMINOTRANSFERASE (AST), grade 2	1 33.3%	0 0%	2 7.7%
ASPARTATE AMINOTRANSFERASE (AST), grade 3	0 0%	1 33.3%	0 0%
BILIRUBIN, TOTAL, grade 1	3 100%	2 66.7%	1 3.8%
BILIRUBIN, TOTAL, grade 2	4 133.3%	3 100%	1 3.8%
BILIRUBIN, TOTAL, grade 3	1 33.3%	0 0%	0 0%
CREATININE, grade 1	7 233.3%	5 166.7%	6 23.1%
CREATININE, grade 2	5 166.7%	2 66.7%	2 7.7%
CALCIUM, TOTAL, grade 1	7 233.3%	3 100%	3 11.5%
CALCIUM, TOTAL, grade 2	5 166.7%	5 166.7%	7 26.9%
CALCIUM, TOTAL, grade 3	0 0%	1 33.3%	0 0%
PHOSPHORUS, INORGANIC, grade 1	0 0%	0 0%	1 3.8%
PHOSPHORUS, INORGANIC, grade 2	3 100%	2 66.7%	1 3.8%
PHOSPHORUS, INORGANIC, grade 3	2 66.7%	0 0%	2 7.7%
PHOSPHORUS, INORGANIC, grade 4	0 0%	1 33.3%	0 0%
POTASSIUM, SERUM, grade 1	4 133.3%	3 100%	5 19.2%
POTASSIUM, SERUM, grade 2	0 0%	1 33.3%	0 0%
POTASSIUM, SERUM, grade 3	1 33.3%	2 66.7%	4 15.4%
POTASSIUM, SERUM, grade 4	1 33.3%	1 33.3%	0 0%
SODIUM, SERUM, grade 1	9 300%	3 100%	7 26.9%
SODIUM, SERUM, grade 2	0 0%	1 33.3%	0 0%
SODIUM, SERUM, grade 3	0 0%	3 100%	4 15.4%
HEMOGLOBIN, grade 2	2 66.7%	4 133.3%	4 15.4%
HEMOGLOBIN, grade 3	22 733.3%	10 333.3%	17 65.4%
PLATELET COUNT, grade 2	0 0%	0 0%	1 3.8%
PLATELET COUNT, grade 3	1 33.3%	1 33.3%	3 11.5%
PLATELET COUNT, grade 4	23 766.7%	13 433.3%	17 65.4%
ABSOLUTE NEUTROPHIL COUNT, grade 1	2 66.7%	1 33.3%	0 0%
ABSOLUTE NEUTROPHIL COUNT, grade 2	0 0%	1 33.3%	1 3.8%
ABSOLUTE NEUTROPHIL COUNT, grade 3	3 100%	0 0%	1 3.8%
ABSOLUTE NEUTROPHIL COUNT, grade 4	18 600%	10 333.3%	16 61.5%
LEUKOCYTES, grade 1	3 100%	0 0%	1 3.8%
LEUKOCYTES, grade 2	3 100%	4 133.3%	0 0%
LEUKOCYTES, grade 3	6 200%	4 133.3%	5 19.2%
LEUKOCYTES, grade 4	8 266.7%	1 33.3%	10 38.5%
LYMPHOCYTES (ABSOLUTE), grade 1	3 100%	4 133.3%	1 3.8%
LYMPHOCYTES (ABSOLUTE), grade 2	7 233.3%	1 33.3%	7 26.9%
LYMPHOCYTES (ABSOLUTE), grade 3	5 166.7%	0 0%	7 26.9%
LYMPHOCYTES (ABSOLUTE), grade 4	0 0%	0 0%	1 3.8%
NEUTROPHILS (ABSOLUTE), grade 1	1 33.3%	0 0%	0 0%
NEUTROPHILS (ABSOLUTE), grade 2	1 33.3%	2 66.7%	1 3.8%
NEUTROPHILS (ABSOLUTE), grade 3	3 100%	0 0%	1 3.8%
NEUTROPHILS (ABSOLUTE), grade 4	18 600%	10 333.3%	16 61.5%

15. Secondary Outcome

Title	Number of Participants With Anti-drug Antibodies (ADA) Positive for Ulocuplumab - Phases 1 and 2
Description	Serum samples from ulocuplumab treated participants were evaluated for the presence of anti-ulocuplumab antibodies
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All participants treated with ulocuplumab

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
Measure Participants	3	3	21	14
Number [Participants]	0 0%	0 0%	6 23.1%	0 0%

16. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) - Phases 1 and 2
Description	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
Time Frame	Cycle 1 Day 1

Outcome Measure Data

Analysis Population Description
All treated participants who have evaluable PK profiles

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	3	3	17	14	1
Geometric Mean (Geometric Coefficient of Variation) [µg/mL]	219.354 (19)	265.294 (8)	183.456 (25)	256.906 (22)	212.564 (NA)

17. Secondary Outcome

Title	Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Description	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
Time Frame	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)

Outcome Measure Data

Analysis Population Description
All treated participants who have evaluable PK profiles

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	3	3	22	13	1
Cycle 1 Day 1	0.100 (0)	0.100 (0)	0.100 (0)	0.100 (0)	0.100 (NA)
Cycle 1 Day 8	5.308 (89)	75.890 (30)	10.321 (85)	17.766 (79)	39.609 (NA)
Cycle 1 Day 15	21.748 (91)	125.797 (18)	37.263 (66)	61.250 (64)	175.315 (NA)
Cycle 2 Day 8	41.630 (NA)	96.333 (36)	30.916 (83)	103.322 (67)
Cycle 2 Day 15	72.104 (NA)	126.029 (49)	48.421 (73)	143.724 (58)
Cycle 3 Day 1	78.218 (NA)	13.905 (101)	153.871 (70)
Cycle 3 Day 8	85.993 (NA)	129.580 (42)	37.602 (94)	82.033 (21)
Cycle 4 Day 1	80.409 (64)	4.012 (145)	212.793 (NA)
Cycle 4 Day 8	112.048 (NA)	133.650 (41)	116.657 (83)	77.095 (119)
Cycle 5 Day 1	32.621 (NA)	4.558 (166)	224.703 (NA)
Cycle 5 Day 8	102.751 (NA)	124.996 (48)	34.783 (137)	202.552 (NA)
Cycle 9 Day 1	35.144 (110)	187.930 (NA)
EOT	0.100 (NA)

18. Secondary Outcome

Title	Time of Maximum Observed Ulocuplumab Serum Concentration (Tmax) - Phases 1 and 2
Description	The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment
Time Frame	Cycle 1 Day 1

Outcome Measure Data

Analysis Population Description
All treated participants who have evaluable PK profiles

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	3	3	17	7	1
Median (Full Range) [hour (H)]	1.850	1.933	1.500	2.117	2.03

19. Secondary Outcome

Title	Area Under the Ulocuplumab Concentration-time Curve From Time Zero to the Last Quantifiable Concentration [AUC(0-T)] - Phases 1 and 2
Description	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
Time Frame	Cycle 1 Day 1

Outcome Measure Data

Analysis Population Description
All treated participants who have evaluable PK profiles

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	3	3	17	7	1
Geometric Mean (Geometric Coefficient of Variation) [µg.h/mL]	9455.529 (10)	21158.725 (9)	8152.698 (50)	13744.382 (37)	16502.463 (NA)

20. Secondary Outcome

Title	Area Under the Ulocuplumab Concentration-time Curve in One Dosing Interval [AUC(TAU)] - Phases 1 and 2
Description	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
Time Frame	Cycle 1 Day 1

Outcome Measure Data

Analysis Population Description
All treated participants who have evaluable PK profiles

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	3	3	13	7	1
Geometric Mean (Geometric Coefficient of Variation) [µg.h/mL]	9455.529 (10)	21158.725 (9)	10082.624 (38)	13826.833 (36)	14257.807 (NA)

21. Secondary Outcome

Title	Area Under the Ulocuplumab Concentration-time Curve From Time Zero to Infinity [AUC(INF)] - Phases 1 and 2
Description	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
Time Frame	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)

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	0	0	0	0	0

22. Secondary Outcome

Title	Elimination Half-life (T-HALF) - Phases 1 and 2
Description	The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment T-HALF determined as 0.693/λz
Time Frame	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)

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	0	0	0	0	0

23. Secondary Outcome

Title	Total Body Clearance of Ulocuplumab (CLT) - Phases 1 and 2
Description	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
Time Frame	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)

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	0	0	0	0	0

24. Secondary Outcome

Title	Volume of Distribution at Steady State (Vss) - Phases 1 and 2
Description	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
Time Frame	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)

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	0	0	0	0	0

25. Secondary Outcome

Title	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
Description	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. CR = complete response CRi = complete response, incomplete blood count PR = partial remission
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All randomized participants

Arm/Group Title	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
Measure Participants	26	14
Number (95% Confidence Interval) [Percentage of participants]	19.2 640%	7.1 236.7%

26. Secondary Outcome

Title	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
Description	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.
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All randomized participants with CR/CRi

Arm/Group Title	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
Measure Participants	4	1
Median (Full Range) [Months]	2.4	4.3

27. Secondary Outcome

Title	Rate of Complete Remission (CR/CRi) and Overall Rate of Remission in Participants Treated With LDAC Only - Phase 2
Description	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. CR = complete response CRi = complete response, incomplete blood count PR = partial remission
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All randomized participants

Arm/Group Title	LDAC - Ph2
Arm/Group Description	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
Measure Participants	24
CR/CRi	25.0 833.3%
Overall remission rate	25.0 833.3%

28. Secondary Outcome

Title	Duration of Response in Participants With CR/CRi Treated With LDAC Only - Phase 2
Description	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.
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All randomized participants with CR/CRi

Arm/Group Title	LDAC - Ph2
Arm/Group Description	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
Measure Participants	6
Median (Full Range) [Months]	5.7

29. Secondary Outcome

Title	Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Description	Change from baseline of ECG endpoints Heart rate measured in beats per minute (bpm)
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	3	3	15	13	9
Cycle 2 Day 1	26.0 (63.6)	4.0 (18.4)	1.8 (11.3)	-0.9 (20.0)	-3.0 (7.6)
Cycle 3, Day 1	-2.3 (18.8)	0.0 (15.6)	5.8 (14.2)	12.7 (14.3)	1.7 (10.2)
Cycle 4, Day 1	-1.0	-16.0 (5.7)	-0.1 (9.9)	11.0 (40.6)	1.3 (16.7)
Cycle 5, Day 1	-6.0	1.5 (7.8)	4.3 (12.3)	10.5 (2.1)	8.8 (27.5)
Cycle 6, Day 1	-6.0	-6.0 (16.5)	6.8 (5.3)	7.4 (14.9)
Cycle 7, Day 1	-11.7 (18.6)	-3.5 (5.9)	12.0 (NA)	6.5 (13.5)
Cycle 8, Day 1	-1.0	0.7 (2.1)	11.0 (NA)	0.8 (11.4)
Cycle 9, Day 1	-17.0 (11.3)	7.0 (7.1)	3.0 (NA)	0.6 (8.9)
Cycle 10, Day 1	-3.0	-16.0 (NA)	9.3 (5.1)	2.0 (1.4)
Cycle 11, Day 1	-12.0	10.0 (NA)	-0.3 (6.7)
Cycle 12, Day 1	5.0 (NA)	19.0 (NA)	7.0 (2.8)
Cycle 13, Day 1	-9.0	8.0 (NA)	4.0 (2.8)
Cycle 14, Day 1	14.0 (NA)
Cycle 15, Day 1	-10.0	8.0 (NA)
Cycle 16, Day 1	18.0 (NA)

30. Secondary Outcome

Title	Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Description	Change from baseline of ECG endpoints PR interval measured in milliseconds (msec)
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	3	3	15	10	9
Cycle 2 Day 1	4.0 (NA)	-14.0 (19.8)	1.1 (23.9)	-5.1 (9.9)	1.2 (5.3)
Cycle 3, Day 1	8.0 (6.0)	-12.0 (0.0)	-5.3 (26.2)	-2.8 (8.4)	-1.9 (7.5)
Cycle 4, Day 1	14.0 (NA)	-13.0 (1.4)	-16.3 (28.4)	-10.0 (NA)	-11.9 (15.7)
Cycle 5, Day 1	-2.0 (NA)	-16.0 (2.8)	-7.6 (24.5)	-11.0 (7.1)	-24.6 (7.2)
Cycle 6, Day 1	-44.0 (NA)	-19.3 (9.2)	-12.8 (21.8)	-3.4 (19.5)
Cycle 7, Day 1	-17.3 (9.5)	-6.8 (12.0)	-2.0 (NA)	-8.3 (20.9)
Cycle 8, Day 1	4.0 (NA)	-5.3 (27.2)	-6.0 (NA)	-9.4 (16.2)
Cycle 9, Day 1	-10.0 (0.0)	-17.0 (46.7)	6.0 (NA)	0.6 (8.5)
Cycle 10, Day 1	-4.0 (NA)	-2.0 (NA)	-11.3 (30.1)	1.0 (1.4)
Cycle 11, Day 1	4.0 (NA)	4.0 (NA)	-1.7 (12.7)
Cycle 12, Day 1	-60.0 (NA)	-4.0 (NA)	-5.0 (1.4)
Cycle 13, Day 1	-2.0 (NA)	-44.0 (NA)	3.0 (1.4)
Cycle 14, Day 1	-54.0 (NA)
Cycle 15, Day 1	0.0 (NA)	-10.0 (NA)
Cycle 16, Day 1	-2.0 (NA)

31. Secondary Outcome

Title	Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Description	Change from baseline of ECG endpoints QRS interval measured in milliseconds (msec)
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	3	3	15	13	9
Cycle 2 Day 1	0.0 (5.7)	-2.0 (5.7)	5.1 (11.3)	0.5 (9.6)	4.8 (12.5)
Cycle 3, Day 1	3.3 (7.6)	-2.0 (5.7)	-1.3 (7.6)	2.0 (3.4)	1.4 (8.2)
Cycle 4, Day 1	0.0 (NA)	1.0 (1.4)	2.7 (8.8)	-3.3 (6.1)	6.4 (16.1)
Cycle 5, Day 1	8.0 (NA)	-4.0 (2.8)	1.8 (9.5)	2.0 (5.7)	-1.4 (2.4)
Cycle 6, Day 1	6.0 (NA)	-2.7 (4.2)	-1.8 (6.2)	5.4 (14.7)
Cycle 7, Day 1	-2.7 (4.2)	-3.3 (7.0)	-10.0 (NA)	-1.5 (4.9)
Cycle 8, Day 1	2.0 (NA)	0.7 (2.3)	-8.0 (NA)	2.6 (6.9)
Cycle 9, Day 1	-1.0 (1.4)	-2.0 (8.5)	-6.0 (NA)	0.0 (3.2)
Cycle 10, Day 1	2.0 (NA)	-4.0 (NA)	-2.3 (8.6)	9.5 (4.9)
Cycle 11, Day 1	6.0 (NA)	-4.0 (NA)	9.0 (7.5)
Cycle 12, Day 1	-6.0 (NA)	-8.0 (NA)	10.0 (5.7)
Cycle 13, Day 1	2.0 (NA)	-12.0 (NA)	3.5 (10.6)
Cycle 14, Day 1	-10.0 (NA)
Cycle 15, Day 1	6.0 (NA)	8.0 (NA)
Cycle 16, Day 1	7.0 (NA)

32. Secondary Outcome

Title	Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Description	Change from baseline of ECG endpoints QT interval measured in milliseconds (msec)
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All treated participants

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	3	3	15	13	9
Cycle 2 Day 1	-41.0 (94.8)	-5.0 (7.1)	4.5 (25.5)	10.4 (50.1)	14.2 (33.7)
Cycle 3, Day 1	10.0 (36.7)	7.0 (29.7)	-15.4 (30.6)	-10.7 (41.3)	13.7 (41.7)
Cycle 4, Day 1	-60.0 (NA)	35.0 (32.5)	10.1 (22.8)	-12.7 (104.3)	-1.4 (47.9)
Cycle 5, Day 1	12.0 (NA)	13.0 (15.6)	2.2 (32.1)	-5.0 (26.9)	-27.6 (75.5)
Cycle 6, Day 1	2.0 (NA)	6.0 (26.9)	-11.8 (19.1)	-3.6 (39.3)
Cycle 7, Day 1	29.3 (20.0)	11.8 (13.6)	-8.0 (NA)	-8.8 (28.3)
Cycle 8, Day 1	2.0 (NA)	2.0 (2.0)	-24.0 (NA)	0.8 (35.5)
Cycle 9, Day 1	37.0 (9.9)	-23.0 (21.2)	-14.0 (NA)	-24.4 (23.0)
Cycle 10, Day 1	6.0 (NA)	14.0 (NA)	-18.3 (18.6)	-6.0 (11.3)
Cycle 11, Day 1	16.0 (NA)	-22.0 (NA)	7.0 (2.6)
Cycle 12, Day 1	-4.0 (NA)	-36.0 (NA)	-6.5 (27.6)
Cycle 13, Day 1	20.0 (NA)	-40.0 (NA)	-15.0 (18.4)
Cycle 14, Day 1	-44.0 (NA)
Cycle 15, Day 1	36.0 (NA)	-19.0 (NA)
Cycle 16, Day 1	-105.0 (NA)

33. Secondary Outcome

Title	Overall Survival (OS) - Phases 1 and 2
Description	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.
Time Frame	From first dose until a minimum follow-up of up to 2 months

Outcome Measure Data

Analysis Population Description
All treated participants for phase 2. Phase 1 OS data not collected.

Arm/Group Title	ULO 600mg + LDAC - Ph1	ULO 800mg + LDAC - Ph1	ULO 800mg + LDAC - Ph2	ULO 1000mg + LDAC - Ph2	LDAC - Ph2
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)	Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)	Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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
Measure Participants	0	0	26	14	22
Median (Full Range) [Months]	3.3	3.0	6.9

Adverse Events

	Ulo 600mg+LDAC		Ulo 800mg+LDAC		Ulocuplumab 800mg + LDAC 20mg BID		Ulocuplumab 1000mg + LDAC 20mg BID		LDAC 20mg BID
Time Frame	Includes on-treatment events from first dose to within 100 days of last dose
Adverse Event Reporting 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.

Arm/Group Title	Ulo 600mg+LDAC		Ulo 800mg+LDAC		Ulocuplumab 800mg + LDAC 20mg BID		Ulocuplumab 1000mg + LDAC 20mg BID		LDAC 20mg BID
Arm/Group Description	Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)		Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)		Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)		Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (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.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)		19/26 (73.1%)		10/14 (71.4%)		16/22 (72.7%)
Serious Adverse Events
	Ulo 600mg+LDAC		Ulo 800mg+LDAC		Ulocuplumab 800mg + LDAC 20mg BID		Ulocuplumab 1000mg + LDAC 20mg BID		LDAC 20mg BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)		1/3 (33.3%)		21/26 (80.8%)		8/14 (57.1%)		15/22 (68.2%)
Blood and lymphatic system disorders
Anaemia	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Disseminated intravascular coagulation	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Febrile neutropenia	2/3 (66.7%)		0/3 (0%)		8/26 (30.8%)		5/14 (35.7%)		6/22 (27.3%)
Cardiac disorders
Arrhythmia	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Cardiac disorder	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Cardiac failure	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Eye disorders
Cataract	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Gastrointestinal disorders
Colitis	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Diarrhoea	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		2/22 (9.1%)
Gastrointestinal haemorrhage	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		0/22 (0%)
Intestinal obstruction	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Nausea	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Oesophagitis	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Vomiting	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
General disorders
Catheter site haemorrhage	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Complication associated with device	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Death	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Fatigue	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Pyrexia	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Infections and infestations
Bacterial infection	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Clostridium difficile colitis	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Lung infection	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		0/22 (0%)
Oesophageal candidiasis	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Pneumonia	0/3 (0%)		0/3 (0%)		3/26 (11.5%)		0/14 (0%)		1/22 (4.5%)
Pneumonia fungal	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Sepsis	0/3 (0%)		0/3 (0%)		3/26 (11.5%)		2/14 (14.3%)		1/22 (4.5%)
Septic shock	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		1/22 (4.5%)
Sinusitis	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Skin infection	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Injury, poisoning and procedural complications
Wound dehiscence	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Investigations
Amylase increased	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Metabolism and nutrition disorders
Dehydration	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		1/22 (4.5%)
Hypokalaemia	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Lactic acidosis	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Tumour lysis syndrome	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		1/22 (4.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Epstein-Barr virus associated lymphoproliferative disorder	0/3 (0%)		1/3 (33.3%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Malignant neoplasm progression	0/3 (0%)		0/3 (0%)		5/26 (19.2%)		2/14 (14.3%)		6/22 (27.3%)
Nervous system disorders
Cerebrovascular accident	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Dizziness	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Seizure	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Syncope	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Psychiatric disorders
Confusional state	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Epistaxis	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Pulmonary embolism	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Pulmonary haemorrhage	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Pulmonary oedema	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		1/22 (4.5%)
Respiratory failure	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		1/14 (7.1%)		0/22 (0%)
Vascular disorders
Circulatory collapse	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Deep vein thrombosis	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Hypotension	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Neurogenic shock	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Other (Not Including Serious) Adverse Events
	Ulo 600mg+LDAC		Ulo 800mg+LDAC		Ulocuplumab 800mg + LDAC 20mg BID		Ulocuplumab 1000mg + LDAC 20mg BID		LDAC 20mg BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		3/3 (100%)		25/26 (96.2%)		14/14 (100%)		22/22 (100%)
Blood and lymphatic system disorders
Anaemia	2/3 (66.7%)		3/3 (100%)		11/26 (42.3%)		3/14 (21.4%)		8/22 (36.4%)
Febrile neutropenia	1/3 (33.3%)		3/3 (100%)		5/26 (19.2%)		4/14 (28.6%)		7/22 (31.8%)
Increased tendency to bruise	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Leukocytosis	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		1/22 (4.5%)
Neutropenia	0/3 (0%)		0/3 (0%)		4/26 (15.4%)		0/14 (0%)		0/22 (0%)
Thrombocytopenia	0/3 (0%)		0/3 (0%)		6/26 (23.1%)		0/14 (0%)		2/22 (9.1%)
Cardiac disorders
Atrial fibrillation	1/3 (33.3%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		0/22 (0%)
Cardiac failure	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		3/22 (13.6%)
Tachycardia	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		0/22 (0%)
Ear and labyrinth disorders
Ear congestion	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Ear discomfort	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Eye disorders
Dry eye	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Gastrointestinal disorders
Abdominal distension	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		2/22 (9.1%)
Abdominal pain	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		1/14 (7.1%)		1/22 (4.5%)
Abdominal pain upper	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		0/22 (0%)
Constipation	1/3 (33.3%)		1/3 (33.3%)		10/26 (38.5%)		2/14 (14.3%)		5/22 (22.7%)
Diarrhoea	0/3 (0%)		0/3 (0%)		6/26 (23.1%)		3/14 (21.4%)		5/22 (22.7%)
Dyspepsia	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		1/22 (4.5%)
Dysphagia	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		0/22 (0%)
Enteritis	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Flatulence	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Gastritis	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		1/22 (4.5%)
Glossodynia	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Haemorrhoids	1/3 (33.3%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		2/22 (9.1%)
Ileus	0/3 (0%)		1/3 (33.3%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Mouth ulceration	0/3 (0%)		0/3 (0%)		0/26 (0%)		2/14 (14.3%)		1/22 (4.5%)
Nausea	1/3 (33.3%)		2/3 (66.7%)		6/26 (23.1%)		8/14 (57.1%)		6/22 (27.3%)
Pancreatitis	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		1/22 (4.5%)
Periodontal disease	1/3 (33.3%)		1/3 (33.3%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Stomatitis	1/3 (33.3%)		3/3 (100%)		5/26 (19.2%)		3/14 (21.4%)		4/22 (18.2%)
Vomiting	1/3 (33.3%)		1/3 (33.3%)		4/26 (15.4%)		1/14 (7.1%)		3/22 (13.6%)
General disorders
Asthenia	0/3 (0%)		0/3 (0%)		3/26 (11.5%)		0/14 (0%)		2/22 (9.1%)
Catheter site erythema	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		0/22 (0%)
Chills	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		3/14 (21.4%)		2/22 (9.1%)
Early satiety	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Fatigue	0/3 (0%)		0/3 (0%)		5/26 (19.2%)		4/14 (28.6%)		5/22 (22.7%)
Generalised oedema	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		0/22 (0%)
Malaise	0/3 (0%)		0/3 (0%)		3/26 (11.5%)		0/14 (0%)		1/22 (4.5%)
Mass	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Mucosal inflammation	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		1/22 (4.5%)
Non-cardiac chest pain	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		2/14 (14.3%)		0/22 (0%)
Oedema peripheral	1/3 (33.3%)		2/3 (66.7%)		6/26 (23.1%)		1/14 (7.1%)		4/22 (18.2%)
Pyrexia	2/3 (66.7%)		2/3 (66.7%)		8/26 (30.8%)		5/14 (35.7%)		5/22 (22.7%)
Hepatobiliary disorders
Drug-induced liver injury	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Hepatic congestion	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Hepatic function abnormal	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		1/22 (4.5%)
Hepatosplenomegaly	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Hyperbilirubinaemia	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		1/22 (4.5%)
Immune system disorders
Hypersensitivity	1/3 (33.3%)		1/3 (33.3%)		1/26 (3.8%)		2/14 (14.3%)		0/22 (0%)
Infections and infestations
Device related infection	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		2/22 (9.1%)
Gingivitis	0/3 (0%)		0/3 (0%)		0/26 (0%)		2/14 (14.3%)		0/22 (0%)
Herpes simplex	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Herpes zoster	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Lung infection	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		3/22 (13.6%)
Oral candidiasis	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		2/22 (9.1%)
Otitis media	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Pneumonia	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		1/22 (4.5%)
Sepsis	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		0/22 (0%)
Skin infection	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Subcutaneous abscess	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Upper respiratory tract infection	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Urinary tract infection	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		2/22 (9.1%)
Injury, poisoning and procedural complications
Allergic transfusion reaction	1/3 (33.3%)		1/3 (33.3%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Compression fracture	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Fall	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		2/22 (9.1%)
Infusion related reaction	0/3 (0%)		0/3 (0%)		0/26 (0%)		2/14 (14.3%)		2/22 (9.1%)
Procedural pain	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		0/22 (0%)
Transfusion reaction	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Investigations
Alanine aminotransferase increased	1/3 (33.3%)		0/3 (0%)		2/26 (7.7%)		1/14 (7.1%)		2/22 (9.1%)
Amylase increased	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		0/22 (0%)
Aspartate aminotransferase increased	1/3 (33.3%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Blood alkaline phosphatase increased	0/3 (0%)		1/3 (33.3%)		1/26 (3.8%)		1/14 (7.1%)		1/22 (4.5%)
Blood bilirubin increased	0/3 (0%)		1/3 (33.3%)		3/26 (11.5%)		1/14 (7.1%)		0/22 (0%)
Blood creatine phosphokinase increased	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Blood creatinine increased	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		0/22 (0%)
C-reactive protein increased	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		2/22 (9.1%)
Electrocardiogram QT prolonged	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		0/22 (0%)
Lipase increased	1/3 (33.3%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		2/22 (9.1%)
Neutrophil count decreased	2/3 (66.7%)		0/3 (0%)		3/26 (11.5%)		1/14 (7.1%)		6/22 (27.3%)
Platelet count decreased	2/3 (66.7%)		3/3 (100%)		6/26 (23.1%)		4/14 (28.6%)		8/22 (36.4%)
Troponin T increased	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Weight decreased	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		2/22 (9.1%)
White blood cell count decreased	0/3 (0%)		0/3 (0%)		5/26 (19.2%)		1/14 (7.1%)		3/22 (13.6%)
Metabolism and nutrition disorders
Decreased appetite	1/3 (33.3%)		0/3 (0%)		3/26 (11.5%)		2/14 (14.3%)		4/22 (18.2%)
Dehydration	1/3 (33.3%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		1/22 (4.5%)
Diabetes mellitus	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Fluid overload	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Glucose tolerance impaired	0/3 (0%)		1/3 (33.3%)		0/26 (0%)		0/14 (0%)		1/22 (4.5%)
Hyperglycaemia	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		2/22 (9.1%)
Hyperkalaemia	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		2/22 (9.1%)
Hypermagnesaemia	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Hypernatraemia	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		0/22 (0%)
Hypoalbuminaemia	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		1/14 (7.1%)		1/22 (4.5%)
Hypoglycaemia	0/3 (0%)		1/3 (33.3%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Hypokalaemia	1/3 (33.3%)		1/3 (33.3%)		1/26 (3.8%)		3/14 (21.4%)		3/22 (13.6%)
Hypomagnesaemia	0/3 (0%)		0/3 (0%)		3/26 (11.5%)		0/14 (0%)		0/22 (0%)
Hyponatraemia	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		2/14 (14.3%)		1/22 (4.5%)
Metabolic acidosis	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		1/22 (4.5%)
Tumour lysis syndrome	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		0/22 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		2/22 (9.1%)
Back pain	2/3 (66.7%)		0/3 (0%)		0/26 (0%)		4/14 (28.6%)		0/22 (0%)
Bone pain	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Costochondritis	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Joint swelling	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Muscular weakness	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Musculoskeletal chest pain	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Musculoskeletal pain	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		1/22 (4.5%)
Neck pain	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		2/14 (14.3%)		1/22 (4.5%)
Pain in extremity	1/3 (33.3%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		0/22 (0%)
Polymyalgia rheumatica	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Tendonitis	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		0/14 (0%)		3/22 (13.6%)
Nervous system disorders
Dizziness	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		2/22 (9.1%)
Headache	0/3 (0%)		0/3 (0%)		3/26 (11.5%)		3/14 (21.4%)		2/22 (9.1%)
Psychiatric disorders
Adjustment disorder with depressed mood	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Anxiety	0/3 (0%)		0/3 (0%)		0/26 (0%)		2/14 (14.3%)		0/22 (0%)
Confusional state	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		0/22 (0%)
Delirium	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Insomnia	0/3 (0%)		0/3 (0%)		7/26 (26.9%)		1/14 (7.1%)		1/22 (4.5%)
Renal and urinary disorders
Acute kidney injury	1/3 (33.3%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		0/22 (0%)
Haematuria	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Renal tubular disorder	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Reproductive system and breast disorders
Breast pain	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Genital ulceration	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Prostatitis	0/3 (0%)		1/3 (33.3%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/3 (0%)		2/3 (66.7%)		6/26 (23.1%)		3/14 (21.4%)		2/22 (9.1%)
Dyspnoea	0/3 (0%)		0/3 (0%)		5/26 (19.2%)		4/14 (28.6%)		1/22 (4.5%)
Dyspnoea exertional	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Epistaxis	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		1/14 (7.1%)		0/22 (0%)
Hypoxia	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		0/22 (0%)
Interstitial lung disease	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Oropharyngeal pain	0/3 (0%)		1/3 (33.3%)		3/26 (11.5%)		2/14 (14.3%)		1/22 (4.5%)
Pleural effusion	0/3 (0%)		0/3 (0%)		1/26 (3.8%)		1/14 (7.1%)		1/22 (4.5%)
Productive cough	0/3 (0%)		0/3 (0%)		3/26 (11.5%)		0/14 (0%)		0/22 (0%)
Rhinorrhoea	0/3 (0%)		0/3 (0%)		0/26 (0%)		2/14 (14.3%)		0/22 (0%)
Stridor	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Upper respiratory tract inflammation	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Wheezing	0/3 (0%)		0/3 (0%)		0/26 (0%)		2/14 (14.3%)		1/22 (4.5%)
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis	0/3 (0%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		2/22 (9.1%)
Dermatitis allergic	0/3 (0%)		1/3 (33.3%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Drug eruption	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		0/14 (0%)		0/22 (0%)
Dry skin	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		1/22 (4.5%)
Ecchymosis	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		2/22 (9.1%)
Erythema	0/3 (0%)		0/3 (0%)		0/26 (0%)		2/14 (14.3%)		1/22 (4.5%)
Petechiae	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		2/14 (14.3%)		0/22 (0%)
Pruritus	0/3 (0%)		1/3 (33.3%)		0/26 (0%)		1/14 (7.1%)		1/22 (4.5%)
Rash	1/3 (33.3%)		0/3 (0%)		0/26 (0%)		3/14 (21.4%)		2/22 (9.1%)
Rash maculo-papular	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		1/14 (7.1%)		2/22 (9.1%)
Skin exfoliation	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Vascular disorders
Haematoma	0/3 (0%)		0/3 (0%)		2/26 (7.7%)		0/14 (0%)		1/22 (4.5%)
Haemorrhage	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Hypertension	1/3 (33.3%)		0/3 (0%)		3/26 (11.5%)		2/14 (14.3%)		1/22 (4.5%)
Hypotension	0/3 (0%)		0/3 (0%)		0/26 (0%)		1/14 (7.1%)		0/22 (0%)
Vasculitis	0/3 (0%)		0/3 (0%)		3/26 (11.5%)		0/14 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

The only disclosure restriction on the PI is that 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. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	Bristol-Myers Squibb Study Director
Organization	Bristol-Myers Squibb
Phone	Please email:
Email	Clinical.Trials@bms.com

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT02305563

Other Study ID Numbers:

CA212-016

First Posted:

Dec 2, 2014

Last Update Posted:

Sep 16, 2021

Last Verified:

Aug 1, 2021

An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia

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