Phase 3 Trial of Revumenib Combined with Intensive Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia with NPM1 Mutation

What this Trial Is About

Researchers are evaluating whether adding the drug revumenib to standard intensive chemotherapy can improve outcomes for participants newly diagnosed with Acute Myeloid Leukemia AML who have a specific genetic mutation called NPM1. This phase 3 study compares revumenib plus chemotherapy against chemotherapy alone and also monitors the safety of combining revumenib with chemotherapy. Participants are randomly assigned to one of two groups one group receives oral revumenib combined with an intensive chemotherapy regimen including cytarabine and daunorubicin delivered by intravenous infusion, and the other group receives a placebo plus the same chemotherapy regimen. The study uses a quadruple masking design to keep participants and researchers unaware of group assignment. Treatment and monitoring continue with primary outcomes measured up to two years. During the study, participants undergo various assessments including evaluations of event-free survival and remission rates related to measurable residual disease. Secondary outcomes include overall survival, remission durations, response rates, adverse events, and patient-reported fatigue scores. Safety and treatment effects are monitored closely, with follow-up extending up to five years. Participants health status and laboratory functions such as liver, kidney, and cardiac function are regularly assessed throughout the trial.

Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation