A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT05168202
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Leukemia, Myeloid, Acute
- Myelodysplastic Syndromes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CC-95251 — DRUGSpecified dose on specified days
- Azacitidine — DRUGSpecified dose on specified days
- Venetoclax — DRUGSpecified dose on specified days
Study Details
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.
Key Dates
- Start date
- Jan 19, 2022
- Status verified
- Sep 2025
- Primary completion
- Jul 30, 2024
- Completion
- Jul 30, 2024
Study Design
- Enrollment
- 56 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CC-95251 monotherapy
- Experimental: CC-95251 + azacitidine
- Experimental: CC-95251 + azacitidine + venetoclax
Primary Outcome Measure
Number of Participants With DLTs [ Time Frame: From Cycle 1 Day 1 to Cycle 1 Day 28 up to 42 post first dose of cycle 1 (upto 42 days) ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0030 | Los Angeles | California | 90095 | - |
| Local Institution - 0031 | Palo Alto | California | 94304 | - |
| Local Institution - 0047 | Miami | Florida | 33136 | - |
| Local Institution - 0001 | Houston | Texas | 77030 | - |
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