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Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML
Sponsor: UNC Lineberger Comprehensive Cancer Center
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2026-07
Completion Date
2028-07
Last Updated
2026-05-27
Healthy Volunteers
No
Conditions
Interventions
Azacitidine
75 mg/m2 Subcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles.
Venetoclax
Per oral 50 mg daily in combination with posaconazole for 1- 28 days, for 3 cycles.
Revumenib
Per oral 160 mg 12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.
Locations (1)
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States