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Menin-Inhibitor Targeted Maintenance in AML

StatusNot Yet Recruiting
PhasePhase 2
Started2026-12
View on ClinicalTrials.gov ↗

Amendment history

2026-06-16
Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v2
Primary endpoint(s) modified1 entry, revised
WasRelapse 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
NowRelapse free survival (RFS) in KMT2Ar, NPM1m, and NUP98r AML in the Intent-to-Treat (ITT) population with a minimum of 1 year of follow-up post-randomization.
Enrollment target144→146
Eligibility criteria+243 characters
Inclusion Criteria: Inclusion Criteria: Aged ≥18 years at the time of signing in [...] emission with one of the following molecular abnormalities: 1. KMT2A-rearranged (KMT2Ar) AML (Excluding KMT2A partial tandem duplication (KMT2A-PTD) 2. NPM1-mutated (NPM1m) AML (Including FLT3-ITD or TKD co-mutation) 3. NUP98-rearranged (NUP98r) AML 5. Planned first allogeneic hematopoietic cell transplantation (allo-HCT) for AML. 6. Transplant Characteristics Planned allo-HCT using bone marro [...] ractice, meeting CIBMTR criteria for conditioning intensity 7. Planned donor: HLA-matched related donor (5/6 or 6/6) Matche [...] / [...]
Secondary endpoints7 to 9 entries
OverallRate of overall survival (OS) in the ITT population RelapseIncidence incidenceof relapse in the ITT population EventRate of event-free survival (EFS) in the ITT population NonRate of non-relapse mortality (NRM) in the ITT population Incidence of clinically significant clinical laboratory abnormalities and shiftsChange from baseline in other observations related to thesafety worstfor post-electrocardiograms (ECGs) measuring QT intervals. Change from baseline gradein other observations related to safety for vital signs. Change from baseline in other observations related to safety for perf [...] [...]
Study description-543 characters
[...] t directly increasing alloreactivity against normal tissues. Findings suggest that revumenib may function as a dual-mechanism maintenance therapy following allo-HCT which includes 1) suppressing residual leukemic clones by disrupting menin-dependent transcriptional programs, and 2) enhancing immune-mediated leukemia control by improving leukemia immunogenici [...]
Collaborators2 entries, revised
SyndaxNational PharmaceuticalsMarrow Donor Program
2026-05-01
Study Status, Eligibility v1
Eligibility criteria-147 characters
[...] no clinical evidence of heart failure: RIC/NMA: ≥50% MAC: ≥5 Pulmonary Function Pulmonary function meeting the following criteria, without [...] ired contraceptive period Exclusion Criteria: Disease Status a. Evidence of active AML prior to HCT, assessed within 42 days before transplant, defined as any of the following: ≥5% bone marrow blasts Circulating blasts within 14 days befo [...] le viral load within 6 months prior to screening Hepatitis B: HBsAg-positive and/or anti-HBc-positive with detectable HBV DNA, or Anti-HBc-positive alone (HBsAg-negative) with detectable HBV DNA Hepatitis C: positive HCV an [...] [...]
2026-04-28
Original filing
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.
Trial Details
NCT Number NCT07563010
Lead Sponsor Center for International Blood and Marrow Transplant Research
Collaborators: National Marrow Donor Program, Dana-Farber Cancer Institute
Conditions Relapsed Adult AML, Stem Cell Transplant Complications, Acute Myeloid Leukemia, Transplant-Related Hematologic Malignancy
Enrollment 146 participants
Start Date 2026-12
Primary Completion 2031-06 (estimated)
Study Completion 2031-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-22