Menin-Inhibitor Targeted Maintenance in AML (NCT07563010) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Menin-Inhibitor Targeted Maintenance in AML
144 participantsStarted 2026-12
Plain-language summary
Revumenib is a first in class oral menin inhibitor that targets a central oncogenic dependency shared across KMT2Ar, NPM1m, and NUP98r AML. In addition to suppressing leukemogenic transcriptional programs and promoting leukemic differentiation, menin inhibition has been shown to modulate epigenetic states linked to antigen presentation and immune recognition. These properties provide a strong biological rationale for evaluating revumenib as maintenance therapy following alloHCT, with the goal of suppressing residual leukemic clones while preserving or enhancing GVL activity during immune reconstitution.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged ≥18 years at the time of signing informed consent
✓. Able to provide written informed consent personally or via a legally authorized representative in accordance with applicable regulatory and institutional requirements
✓. Willing and able to comply with all study procedures and available for the duration of the study
✓. Diagnosis of acute myeloid leukemia (AML) in complete morphologic remission with one of the following molecular abnormalities:
✓. KMT2A-rearranged (KMT2Ar) AML
✓. Excluding KMT2A partial tandem duplication (KMT2A-PTD)
✓. NPM1-mutated (NPM1m) AML
✓. Including FLT3-ITD or TKD co-mutation
Exclusion criteria
✕. Disease Status
✕. Other active malignancy that, in the investigator's judgment, could interfere with safety or efficacy assessment
✕. Treatment with non-protocol antileukemic therapy (donor lymphocyte infusion for relapse prophylaxis or treatment will be considered an EFS event)
✕. Cardiac / QT Risk
✕. Requirement for concomitant medications known to prolong QT/QTc interval, except low-risk agents used as standard supportive care
What they're measuring
1
Relapse Free Survival (RFS) in KMT2Ar, NPM1m, and NUP98r acute leukemias in the Intent-to-Treat (ITT) population with a minimum of 1 year of follow-up post-randomization
Timeframe: From date of randomization until relapse, assessed up to 13 months
Trial details
NCT IDNCT07563010
SponsorCenter for International Blood and Marrow Transplant Research