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NCT04789655 · ClinicalTrials.gov registry record · Phase 1
Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT04789655: Clinical Trial Phase 1 study, sponsored by Celgene.
NCT04789655 is a Phase 1 study that was terminated before completion, run by Celgene. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04789655, a Phase 1 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy. The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.
Primary Outcome
Are defined as toxicities that meet the protocol-specified criteria occurring within the DLT assessment window (Cycle 1, Days 1 to at least 28 and up to 42 days) that cannot be attributed to a clearly identifiable cause such as underlying illness, disease progression, other concurrent illness, or concomitant medication.
Interventions
- DRUG CC-96191
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-06-16 |
| Est. Completion | 2025-04-14 |
| Phase | Phase 1 |
Why NCT04789655 stopped before completion
NCT04789655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which CC-96191 is the first listed.
NCT04789655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04789655 about?
NCT04789655 is a clinical study titled "Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia". This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). The dose escalation (Part A) of the study will explore escalating ...
What is the current status of trial NCT04789655?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2021-06-16. Estimated completion is 2025-04-14.
What interventions are being tested in trial NCT04789655?
The interventions under investigation include: CC-96191 (DRUG).
Who is sponsoring clinical trial NCT04789655?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04789655's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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