Stopped: Other - Protocol moved to Withdrawn
This phase I trial tests the safety, best dose, and effectiveness of revumenib given as maintenance therapy after standard hematopoietic stem cell transplant (HSCT) in patients with acute lymphoblastic leukemia, acute myeloid leukemia, or mixed phenotype acute leukemia. Revumenib binds to a protein called menin, which prevents menin from interacting with another protein called MLL. This results in an inhibition of the proliferation of leukemic cells with certain genetic alterations. Revumenib may inhibit the survival, growth, transformation and proliferation of certain kinds of leukemia cells. It is approved for the treatment of patients with certain types of acute leukemia, but it is not approved for maintenance therapy (treatment that aims to prevent cancer from coming back) after HSCT.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Maximum tolerated dose (MTD)
Timeframe: During cycles 1 and 2 (cycle length = 28 days)
Recommended phase 2 dose (RP2D)
Timeframe: During cycles 1 and 2 (cycle length = 28 days)
Area under the concentration time curve of revumenib
Timeframe: Up to day 7
Maximum concentration of the time curve of revumenib
Timeframe: Up to day 7
Half-life of revumenib
Timeframe: Up to day 7
Clearance of revumenib
Timeframe: Up to day 7