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NOT YET RECRUITING
NCT07605949
PHASE2

Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML

Sponsor: UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

Venetoclax

Per oral 50 mg daily in combination with posaconazole for 1- 28 days, for 3 cycles.

DRUG

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