Study on Revumenib and Mezigdomide for Treating Leukemia

Inclusion Criteria

• Must be 12 years or older and weigh at least 40 kg.
• Willing to follow the study schedule and requirements.
• Have a type of leukemia that has returned or not responded to at least one previous treatment.
• Have specific genetic changes in the leukemia cells, such as NPM1, KMT2A, or NUP98 mutations.
• No restrictions on previous treatment with a menin inhibitor for Phase 1 participants.
• Phase 2 participants must either have never been treated with a menin inhibitor or have been treated before, depending on the study group.
• At least 60 days must have passed since any stem cell transplant, and at least 4 weeks since any donor lymphocyte infusion.
• Must have a performance status score indicating good overall health.
• White blood cell count must be below 25,000/μL before starting the study drug.
• Must have adequate organ function, including liver, kidney, and heart health.

Exclusion Criteria

• Have acute promyelocytic leukemia or isolated myeloid sarcoma.
• Have previously received mezigdomide.
• Have severe complications from leukemia, such as uncontrolled bleeding or severe infections.
• Have another condition that increases risk or makes participation inappropriate.
• Have another active cancer that could interfere with the study.
• Have received other leukemia treatments recently, unless specified exceptions apply.
• Have active graft versus host disease requiring systemic treatment.
• Have significant heart disease or a prolonged QT interval on an ECG.
• Have active infections like HIV, hepatitis B, or hepatitis C.
• Have conditions affecting drug absorption, like severe digestive issues.
• Have active uncontrolled infections.
• Are using certain medications that affect the study drugs.
• Are pregnant or breastfeeding, or not willing to use contraception as required.