NCT06419634TerminatedPhase 1
Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Reason given: Inability to meet protocol objectives
Brief summary (registry, in English)
The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 as a monotherapy, in double combination with Azacitidine and in triple combination with Azacitidine and Venetoclax in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 14 May 2024
- Start date
- 29 May 2024
- Primary completion date
- 28 Aug 2026
- Lead sponsor
- Bristol-Myers Squibb
- NCT number
- NCT06419634
- EudraCT number
- 2024-519537-29
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active malignant solid tumor.
Other
- Acute Promyelocytic Leukemia.
- Clinically active central nervous system leukemia.
- Pregnant or breastfeeding.
- Other protocol-defined inclusion/exclusion criteria apply.
Who the study is looking for
- Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
- Detectable levels of cluster of differentiation 33 (CD33) expression.
- Failed alternative therapies with established benefit.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - | Montreal | Canada | Unknown status |
| - | Toronto | Canada | Unknown status |
| - | Barcelona | Spain | Unknown status |
| - | Seville | Spain | Unknown status |
| - | Boston | United States | Unknown status |
| - | Chicago | United States | Unknown status |
| - | Hackensack | United States | Unknown status |
| - | Houston | United States | Unknown status |
| - | New Haven | United States | Unknown status |
| - | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.