Menin-Inhibitor Targeted Maintenance in AML

Sponsor
Center for International Blood and Marrow Transplant Research
Study ID
NCT07563010
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Myeloid Leukemia
  • Relapsed Adult AML
  • Stem Cell Transplant Complications
  • Transplant-Related Hematologic Malignancy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Revumenib — DRUG
    oral tablets
  • Placebo — DRUG
    oral tablets

Study Details

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.

Key Dates

First listed
May 1, 2026
Start date
Dec 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Revumenib BID
    For patients not taking strong CYP3A4 inhibitor and patients taking strong CYP3A4 inhibitor
  • Placebo Comparator: Placebo BID
    For patients not taking strong CYP3A4 inhibitor and patients taking strong CYP3A4 inhibitor

Primary Outcome Measure

Relapse 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. [ Time Frame: From randomization to the date of event occurrence, assessed for a minimum of 1 year post-randomization. ]

Central Contacts

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