RecruitingPhase 1Phase 2NCT07356154

A Study of Revumenib and Mezigdomide in People With Leukemia

A Phase 1/2 Study of the Menin Inhibitor Revumenib With the CELMod Mezigdomide in Relapsed/Refractory KMT2A-rearanged, NPM1-mutant, and NUP98-rearranged Acute Leukemias


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

52 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out whether the combination of mezigdomide and revumenib is a safe treatment for people with relapsed or refractory KMT2A-r, NUP98-r, and NPM1-m acute leukemias.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — revumenib (a menin inhibitor that targets certain leukemia-driving gene mutations) and mezigdomide (an immune-modulating drug) — for people with relapsed or treatment-resistant acute leukemia. The study includes both adults and children aged 12 and older whose leukemia has specific genetic mutations (NPM1, KMT2A, or NUP98). **You may be eligible if:** - You are 12 years or older and weigh at least 40 kg - You have been diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or mixed phenotype acute leukemia that has relapsed or not responded to at least one prior treatment - Your leukemia has a specific genetic mutation: NPM1, KMT2A translocation, or NUP98 translocation - Your general health status is adequate based on age-appropriate performance scales - Your heart, liver, and kidney function are within acceptable ranges **You may NOT be eligible if:** - You have acute promyelocytic leukemia (APL) or isolated myeloid sarcoma - You have previously been treated with mezigdomide - You have a life-threatening leukemia complication such as uncontrolled bleeding or severe infection - You have another cancer that would make results harder to interpret - You have active graft-versus-host disease (GVHD) of grade 2 or higher requiring treatment - You have active HIV, hepatitis B, or hepatitis C infection - You have had a serious heart event in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRevumenib

Revumenib is a novel menin inhibitor

DRUGMezigdomide

Mezigdomide (CC-92480) is an investigational CELMoD.


Locations(10)

City of Hope Cancer Center (Data collection only)

Duarte, California, United States

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, United States

University of North Carolina (Data Collection Only)

Chapel Hill, North Carolina, United States

MD Anderson Cancer Center (Data Collection Only)

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07356154


Related Trials