Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Study ID
- NCT07605949
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Leukemia Acute Myeloid
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Azacitidine — DRUGSubcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles.
- Venetoclax — DRUGPer oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles.
- Revumenib — DRUGPer oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.
Study Details
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.
Key Dates
- Start date
- Jul 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Jul 31, 2028
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 88 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)Patients with KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) did not receive a treatment.
Primary Outcome Measure
Complete remission rate [ Time Frame: Up to 3 months ]
Central Contacts
- Lauren Higgins919-984-0000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | Joshua Zeidner (PRINCIPAL_INVESTIGATOR) |