A Phase 2 Study of Venetoclax and Revumenib in People With Acute Myeloid Leukemia

Full Title

A Multi-site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib

Purpose

Researchers want to find the best dose of revumenib to give with venetoclax in people with acute myeloid leukemia (AML). The people in this study have AML with minimal residual disease. This means they have a small number of cancer cells remaining in their bodies after treatment. In addition, their cancers have a mutation (change) in the NPM1KMT2A, or NUP98 genes.

Venetoclax blocks Bcl-2, a protein that helps cancer cells survive and resist the effects of anti-cancer treatments. By blocking Bcl-2, venetoclax may cause the death of cancer cells or make them more sensitive to other treatments. It is taken orally (by mouth).

Revumenib is designed to block a protein called menin, which leukemia cells need to divide. By blocking menin, revumenib may prevent cancer cells from growing, stop them from spreading, or make them shrink. It is also taken orally.

Giving venetoclax and revumenib in combination may work better against AML than using either drug alone.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have AML with minimal residual disease and a mutation in the NPM1KMT2A, or NUP98 genes.
  • Not be planning to have a stem cell transplant in the next 30 days.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 12 or older.

Contact

For more information or to see if you can join this study, please call Dr. Aaron Goldberg’s office at 646-608-3752.

Protocol

25-179

Phase

Phase I/II (phases 1 and 2 combined)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06284486