Health TrialsbyHealthPanel

Menin-Inhibitor Targeted Maintenance in AML

ConditionsRelapsed Adult AMLStem Cell Transplant ComplicationsAcute Myeloid LeukemiaTransplant-Related Hematologic Malignancy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCenter for International Blood and Marrow Transplant Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Planned allo-HCT using bone marrow or peripheral blood stem cell graft source.

Disqualifiers

≥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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Revumenib

    Drug

    oral tablets

  • Placebo

    Drug

    oral tablets

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Revumenib BIDExperimental treatment 1 intervention
Group B: Placebo BIDPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

RFS is defined as the time from randomization to the date of relapse or the date of death from any cause, whichever comes first.

Time frame
From randomization to the date of event occurrence, assessed for a minimum of 1 year post-randomization.

Secondary outcomes

1

RFS in the modified ITT (mITT) population

Relapse free survival rate in modified intent to treat population

Time frame
From randomization to the date of event occurrence, assessed for a minimum of 1 year post-randomization
2

Rate of overall survival (OS) in the ITT population

Overall survival rate in the intent-to-treat population

Time frame
From randomization to the date of event occurrence, assessed for a minimum of 1 year post-randomization.
3

Incidence of relapse in the ITT population

Incidence of relapses in intent-to-treat participant population

Time frame
From randomization to the date of event occurrence, assessed for a minimum of 1 year post-randomization.
4

Rate of event-free survival (EFS) in the ITT population

Events such as relapse/progression, death from any cause, graft failure, use of donor lymphocyte infusion which have occurred from time from the date of randomization to the date of event occurrence.

Time frame
From randomization to the date of event occurrence, assessed for a minimum of 1 year post-randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center for International Blood and Marrow Transplant Research

Lead sponsor

National Marrow Donor Program

Collaborator

Dana-Farber Cancer Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: