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NCT04748848 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability and Preliminary Efficacy Study of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia and Treatment-naïve Participants Not Eligible for Intensive Therapy
A Phase 1 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04748848 is a Phase 1 study that was terminated before completion, run by Celgene. The registered enrollment target is 1 participants.
The verdict
NCT04748848, a Phase 1 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
CC-90011-AML-002 is a Phase 1/2, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently with Venetoclax and Azacitidine. This study will include 3 parts: a dose escalation part in R/R AML, a dose escalation part in ndAML (treatment-naïve participants with AML who are ≥ 75 years of age or are ≥ 18 to 74 years of age and otherwise not eligible for intensive induction chemotherapy), and a randomized dose expansion part in ndAML of Venetoclax and Azacitidine with or without CC-90011.
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG CC-90011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2022-03-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04748848
The ClinicalTrials.gov registry entry for NCT04748848 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT04748848 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04748848 about?
NCT04748848 is a clinical study titled "A Safety, Tolerability and Preliminary Efficacy Study of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia and Treatment-naïve Participants Not Eligible for Intensive Therapy". CC-90011-AML-002 is a Phase 1/2, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently with Venetoclax and Azacitidine. This study will include 3 parts: a dose escalation part in R/R AML, a dose escalation part in ndAML (treatment-n...
What is the current status of trial NCT04748848?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2021-10-14. Estimated completion is 2022-03-09.
What interventions are being tested in trial NCT04748848?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), CC-90011 (DRUG).
Who is sponsoring clinical trial NCT04748848?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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