A Phase 1/2 study of Ulocuplumab (BMS-936564)

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222750

Enrollment

126

Registered

2015-01-13

Start date

2015-04-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Interventions

investigational material(s) Generic name etc : ulocuplumab(BMS-936564) INN of investigational material : - Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investiga

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Acute promyelocytic leukemia Current Myelodysplastic syndrome only subjects

Design outcomes

Primary

Measure	Time frame
safety efficacy Phase 1:To assess the safety and tolerability Phase 2 :(expansion cohort) Complete Remission (CR), Complete Remission with incomplete blood count recovery (CRi), Rate of Complete Remission (CR/CRi) Phase 1:Number of patients experiencing a ulocuplumab-related dose limiting toxicity (DLT) during the DLT evaluation period based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) [ Time Frame: Up to 30 days after discontinuation of treatment ] Phase 2:Best overall response based on the Rate of Complete Remission (CR/CRi)	—

Measure

Time frame

safety efficacy Phase 1:To assess the safety and tolerability Phase 2 :(expansion cohort) Complete Remission (CR), Complete Remission with incomplete blood count recovery (CRi), Rate of Complete Remission (CR/CRi) Phase 1:Number of patients experiencing a ulocuplumab-related dose limiting toxicity (DLT) during the DLT evaluation period based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) [ Time Frame: Up to 30 days after discontinuation of treatment ] Phase 2:Best overall response based on the Rate of Complete Remission (CR/CRi)

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Secondary

Measure	Time frame
safety efficacy pharmacokinetics pharmacogenomics Phase 2: 1.Safety and tolerability 2.pharmacokinetic parameter(PK) 3.anti-drug antibody(ADA) 4.The effect of ulocuplumab on ECG intervals 5.Overall remission as well as duration of complete remission 6.Efficacy in subject treated with LDAC alone, to compare with historical controls of LDAC 7.Overall Survival(OS) Phase 2: 1:Time Frame: Up to 30 days after discontinuation of treatment 2:Cmax, Ctrough, Tmax, AUC(0-T), AUC(TAU), AUC(INF), T-HALF, CLT and Vss 3: ADA positive for ulocuplumab 4: QTcF, QT, QRS, PR, heart rate and QTcB as well as the associated changes from base line 5: Overall Remission (OR=PR+CR+Cri),the time from the date of first documented CR or CRi to the date of death, relapse, or initiation of alternative therapy while in remission 7:The time between the first date of treatment and the date of death due to any cause	—

Measure

Time frame

safety efficacy pharmacokinetics pharmacogenomics Phase 2: 1.Safety and tolerability 2.pharmacokinetic parameter(PK) 3.anti-drug antibody(ADA) 4.The effect of ulocuplumab on ECG intervals 5.Overall remission as well as duration of complete remission 6.Efficacy in subject treated with LDAC alone, to compare with historical controls of LDAC 7.Overall Survival(OS) Phase 2: 1:Time Frame: Up to 30 days after discontinuation of treatment 2:Cmax, Ctrough, Tmax, AUC(0-T), AUC(TAU), AUC(INF), T-HALF, CLT and Vss 3: ADA positive for ulocuplumab 4: QTcF, QT, QRS, PR, heart rate and QTcB as well as the associated changes from base line 5: Overall Remission (OR=PR+CR+Cri),the time from the date of first documented CR or CRi to the date of death, relapse, or initiation of alternative therapy while in remission 7:The time between the first date of treatment and the date of death due to any cause

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Countries

Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026