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NCT05168202 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Terminated
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT05168202: Clinical Trial Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT05168202 is a Phase 1 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05168202, a Phase 1 study, was terminated before completion, sponsored by Bristol-Myers Squibb.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
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.
Primary Outcome
A dose-limiting toxicity (DLT) is any treatment-related toxicity during Cycle 1 (Days 1-28, up to 42) not clearly due to illness or external causes. DLTs include: * Any Grade ≥3 non-hematologic toxicity, except specific reversible or manageable cases (e.g., IRR, nausea, diarrhea, fatigue, infection with leukemia, TLS, electrolyte imbalance, liver enzyme elevations, or rash). * Any confirmed Hy's law case (ALT/AST ≥3× ULN + bilirubin \>2× ULN without cholestasis). * Hematologic toxicities: Grade
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG CC-95251
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2022-01-19 |
| Est. Completion | 2024-07-30 |
| Phase | Phase 1 |
Why NCT05168202 stopped before completion
NCT05168202 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT05168202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05168202 about?
NCT05168202 is a clinical study titled "A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes". 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 melodyspl...
What is the current status of trial NCT05168202?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2022-01-19. Estimated completion is 2024-07-30.
What interventions are being tested in trial NCT05168202?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), CC-95251 (DRUG).
Who is sponsoring clinical trial NCT05168202?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05168202's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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