Clinical trial · Interventional
An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia
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
NCT02305563CI-TRIAL-00053930terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed, slow accrual, the standard of care for the patient population changed and we were unable to accrue any longer.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-936564 | Drug | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Ulocuplumab + low dose Cytarabine
- description
- Ulocuplumab + low dose Cytarabine (LDAC) Phase 1 (escalation cohort) - closed for enrollment
- interventionNames
- Drug: BMS-936564
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- Ulocuplumab Dose A + low dose Cytarabine
- description
- Ulocuplumab Dose A + low dose Cytarabine Phase 2 (expansion cohort)
- interventionNames
- Drug: BMS-936564
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- Ulocuplumab Dose B + low dose Cytarabine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.