Petersberg

Researchers are studying the use of revumenib in people with relapsed or refractory acute leukemias, including those with specific genetic changes such as MLL/KMT2A gene rearrangements or NPM1 mutations. The trial has two phases: Phase 1 aims to find the highest safe dose and recommended dose for Phase 2, while Phase 2 evaluates the drug's effectiveness and safety in different types of acute leukemia. This study includes participants with various acute leukemias, including acute myeloid leukemia, acute lymphoblastic leukemia, mixed lineage acute leukemia, and others with specific genetic profiles. In Phase 1, participants receive oral revumenib in one of six groups based on their use of certain antifungal drugs or other medications affecting liver enzymes, with one group also receiving cobicistat daily. Phase 2 enrolls participants in four specific groups depending on their leukemia type and genetic mutations, to further assess the drug's effects. Treatments are given orally, and dosing is carefully increased during Phase 1 to identify safe levels. Participants will be monitored for side effects, drug levels in the body, and treatment responses for up to approximately 1 year in Phase 1 and about 3 years in Phase 2. Assessments include blood tests, bone marrow evaluations, and safety checks. Researchers will track the number of participants experiencing dose-limiting toxicities and adverse events, as well as measure drug exposure and response rates. The study also includes long-term follow-up to observe ongoing safety and treatment outcomes.