Phase 12 Study of Oral Bleximenib for Treating Acute Leukemia with KMT2A and NPM1 Gene Alterations

What this Trial Is About

Researchers are studying bleximenib, an oral drug, in participants with acute leukemia to find the best dose and evaluate its safety and effectiveness. The study includes Phase 1 dose escalation to find recommended doses and Phase 1 dose expansion and Phase 2 to assess safety, tolerability, and anti-leukemia activity. Participants include both pediatric and adult patients with relapsed or refractory acute leukemia, especially those with specific genetic alterations. In Phase 1 Part 1, participants receive increasing doses of bleximenib orally to identify recommended doses based on tolerance. In Phase 1 Part 2, participants receive bleximenib at these doses to further evaluate safety. Phase 2 participants take the recommended dose to study the drugs effect on leukemia. The study monitors participants up to 4 years and 9 months for safety and treatment response. Participants will undergo assessments including monitoring adverse events, dose-limiting toxicities, and treatment responses. Blood tests will measure drug levels and leukemia remission rates. Safety and efficacy are tracked throughout treatment and follow-up, with a focus on remission rates and survival outcomes. The total study duration extends to September 2030, allowing long-term evaluation of bleximenib.

A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)