Phase 3 Study of Revumenib in Combination with Intensive Chemotherapy in Newly Diagnosed NPM1-mutated AML

Who can take part?

Inclusion criteria

• Age 12 years or older and weight 40kg or more
• Newly diagnosed, untreated AML with an NPM1 mutation
• Eligible for intensive chemotherapy
• Adequate kidney, liver, and heart function
• Acceptable performance status
• WBC count within study limits
• Negative pregnancy test and contraception use (if applicable)
• Able to provide informed consent

Exclusion criteria

• Not eligible for standard AML chemotherapy
• FLT3 mutation above study limit
• Prior stem cell or organ transplant
• Acute promyelocytic leukemia (APL)
• Active CNS leukemia
• Significant heart disease or prolonged QT interval
• Serious gastrointestinal conditions affecting drug absorption
• Another active cancer requiring treatment
• Uncontrolled infection, HIV, hepatitis B, or hepatitis C
• Pregnant or breastfeeding
• Prior AML-directed therapy (except permitted emergency treatment)
• Use of prohibited medications or participation in another clinical trial recently/currently

What is involved for me?

Participants who join this study will:

• Undergo screening tests to confirm eligibility
• Receive standard chemotherapy for AML
• Receive either revumenib or placebo in addition to chemotherapy
• Attend regular study visits, including physical examinations and health assessments
• Have blood and bone marrow samples collected to monitor their disease and response to treatment
• Have heart monitoring tests (such as ECGs) and other safety assessments
• Be monitored for side effects and overall health throughout the study
• Attend follow-up visits after treatment to assess long-term outcomes and survival