A Phase 12 Study of Oral Revumenib for Relapsed or Refractory Leukemias Including Those with MLLKMT2A Gene Rearrangement or NPM1 Mutation

What this Trial Is About

Researchers are studying revumenib, an oral drug, in people with relapsed or refractory acute leukemias, including those with specific genetic mutations like MLLKMT2A rearrangements and NPM1 mutations. The study aims to find the highest safe dose and the recommended dose for further studies, as well as to evaluate how well the drug works, its safety, and how well patients tolerate it. This trial includes both a Phase 1 dose-escalation part and a Phase 2 expansion part focused on different leukemia types. In Phase 1, participants receive oral revumenib in one of six groups based on other medications they may be taking, such as antifungal drugs or cobicistat. The study tests increasing doses to find the maximum tolerated dose and recommended dose for Phase 2. In Phase 2, participants are grouped into four cohorts based on their leukemia subtype and genetic mutations to assess the drugs effects and safety over time. Participants will be monitored closely with assessments including blood tests to measure drug levels, side effects, and responses like remission rates. The study tracks outcomes such as adverse events, transfusion independence, and survival over several years. Participants physical health and leukemia status will be regularly evaluated to understand the treatments impact and safety throughout the trial and follow-up periods.

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation