Menin-Inhibitor Targeted Maintenance in AML

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Relapsed Adult AML, Stem Cell Transplant Complications, Acute Myeloid Leukemia, Transplant-Related Hematologic Malignancy

In brief

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 facts

Study ID

NCT07563010

Run by

Center for International Blood and Marrow Transplant Research

People needed

146

Starts

2026-12-01

Expected to finish

2031-06-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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) 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.
• Transplant Characteristics
• Planned allo-HCT using bone marrow or peripheral blood stem cell graft source.
• Planned reduced-intensity/non-myeloablative conditioning (RIC/NMA) or myeloablative conditioning (MAC), using a conditioning regimen permitted- by the protocol and consistent with standard clinical practice, meeting CIBMTR criteria for conditioning intensity
• Planned donor:
• HLA-matched related donor (5/6 or 6/6)
• Matched unrelated donor (8/8)
• Mismatched unrelated donor (7/8)
• Haploidentical donor meeting institutional requirements
• Performance Status:
• Karnofsky Performance Status ≥70%. 9. Cardiac Function: left ventricular ejection fraction (LVEF) by transthoracic echocardiogram (TTE) or multigated acquisition (MUGA) with no clinical evidence of heart failure: RIC/NMA: ≥50% MAC: ≥5 10. Pulmonary function meeting the following criteria, without supplemental oxygen other than CPAP:
• RIC/NMA: DLCO (corrected for hemoglobin) and FEV1 ≥40% predicted
• MAC: DLCO and FEV1 ≥50% predicted
• Renal Function: estimated creatinine clearance (CrCl) ≥45mL/min calculated using the Cockcroft-Gault formula or 24-hour urine collection, consistent with standard eligibility criteria for allogeneic HCT recipients.
• Liver function acceptable per local institutional guidelines for allo-HCT eligibility.
• Reproductive Status: Willingness to use contraception in accordance with local regulations from first study intervention through the required contraceptive period Willingness to use contraception in accordance with local regulations from first study intervention through the required contraceptive period

You may not qualify if…

• 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 before conditioning
• CNS or other extramedullary disease
• 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
• Diagnosis or suspicion of Long QT syndrome, or a family history of Long QT syndrome
• Fridericia's corrected QT interval (QTcF) >450 msec.
• History within 6 months of study entry of:
• i. Myocardial infarction ii. Unstable angina iii. Congestive heart failure (NYHA Class ≥ II) iv. Life-threatening or uncontrolled arrhythmia v. Cerebrovascular accident or transient ischemic attack
• Chronic respiratory disease requiring continuous supplemental oxygen, or other significant organ dysfunction that would adversely affect study participation.
• Active, uncontrolled infection, including any of the following:
• Active, uncontrolled systemic fungal, bacterial, or viral infection within 14 days prior to the start of conditioning
• Any other documented active, uncontrolled infection at the start of conditioning
• Chronic viral infections with evidence of active disease, including:
• HIV: detectable viral load within 6 months prior to screening
• Hepatitis B:
• HBsAg-positive and/or anti-HBc-positive with detectable HBV DNA
• Anti-HBc-positive alone Hepatitis C: positive HCV antibody with detectable HCV RNA
• Planned HCT using cord blood, ex vivo T cell depletion, engineered grafts, or experimental graft sources
• Malabsorption syndrome or GI condition that precludes oral administration, including:
• Inability to swallow oral medications

Full record on ClinicalTrials.gov

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