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

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.

Eligibility

Age range

18–65 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Azacitidine

  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, daily in combination with posaconazole for 1- 28 days, for 3 cycles.

• Drug
  Revumenib

  Per oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.

Location