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NCT07605949 · ClinicalTrials.gov registry record · Phase 2
Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Not yet
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
NCT07605949: Clinical Trial Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT07605949 is a Phase 2 study that has not yet begun recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 88 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07605949, a Phase 2 study, has not yet begun recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
Study Summary
This study is testing a new treatment combination called RAVEN, which includes revumenib, azacitidine, and venetoclax, in patients who are newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A- translocated AML. People with this type of AML often have poor outcomes, so new treatments are needed that may work better and cause fewer side effects. The study has two parts: 1. Induction Phase: Patients will receive treatment for up to 3 cycles. Each cycle lasts 28 days. The goal is to help the leukemia go into remission. 2. Continuation Phase: After remission and blood count recovery, patients will continue treatment until the leukemia returns, side effects become too severe, the patient receives a stem cell transplant, or another reason to stop treatment occurs. Patients who receive an allogeneic stem cell transplant (stem cells from a donor) may also join a separate part of the study to test revumenib as maintenance treatment after transplant.
Primary Outcome
Complete remission (CR) rate will be determined as defined in the protocol Response Criteria. Bone marrow blasts \< 5%; absence of circulating blasts; absence of extramedullary disease; ANC \> 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL)
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Revumenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2026-07 |
| Est. Completion | 2028-07 |
| Phase | Phase 2 |
What is known before NCT07605949 opens enrollment
NCT07605949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT07605949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07605949 about?
NCT07605949 is a clinical study titled "Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML". This study is testing a new treatment combination called RAVEN, which includes revumenib, azacitidine, and venetoclax, in patients who are newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A- translocated AML. People with this type of AML often have poor outcomes, so n...
What is the current status of trial NCT07605949?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2026-07. Estimated completion is 2028-07.
What interventions are being tested in trial NCT07605949?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Revumenib (DRUG).
Who is sponsoring clinical trial NCT07605949?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07605949's enrollment target sits among peer trials
88 803rd of 2000 higher than 1,191 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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