Phase 12 Study of Revumenib and Mezigdomide for Relapsed or Refractory Acute Leukemias with KMT2A, NPM1, or NUP98 Changes

What this Trial Is About

Researchers are evaluating the safety of combining two drugs, mezigdomide and revumenib, in people aged 12 years and older who have relapsed or refractory acute leukemias with specific genetic changes KMT2A-rearranged, NUP98-rearranged, or NPM1-mutant. This study is conducted by Memorial Sloan Kettering Cancer Center and includes phase 1 and phase 2 portions to test different groups of patients, including those who have or have not previously received menin inhibitors. Participants receive treatment with revumenib, a menin inhibitor, and mezigdomide, an investigational CELMoD drug. The study includes several dose-level cohorts where patients are sequentially treated and toxicity is carefully evaluated before moving to the next group. Phase 2 includes two cohorts one for patients who have not received menin inhibitors before and another for those who have. Treatment is given under close monitoring to assess safety and dosing. During the study, participants will undergo screenings, including genetic testing and assessments of organ function and overall health status. Researchers will monitor blood counts, cardiac function, and any side effects. The main outcome measured is the maximum tolerated dose of the drug combination over one year. Participants adherence to the visit schedule and protocol requirements will be tracked, with treatment continuing based on tolerance and response. The total study duration extends to 2029 with careful follow-up to assess safety and treatment effects.

A Study of Revumenib and Mezigdomide in People With Leukemia