Revumenib + Mezigdomide for Acute Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Eytan Stein, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals aged 12 or older, weighing at least 40 kg, with relapsed/refractory acute leukemia (AML, ALL, or mixed phenotype) after failing at least one treatment. They must have specific genetic changes: NPM1c variants or KMT2A/NUP98 translocations. Phase 2 participants are grouped based on prior menin inhibitor treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1A Treatment
The first cohort of 3 patients will be treated at dose level 1A
Phase 1B Treatment
The next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients
Phase 1C Treatment
The next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients
Phase 2 Treatment
Menin Inhibitor Naive Cohort: Up to 24 patients, including up to 6 from phase I
Phase 2 Treatment
Menin Inhibitor Exposed Cohort: Up to 16 patients, including up to 6 from phase I
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mezigdomide
- Revumenib
Trial Overview
The study tests the safety of combining two drugs, Revumenib and Mezigdomide, for people with certain genetic types of acute leukemias that haven't responded to previous treatments. It aims to determine if this drug combination can be an effective therapy.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
In the menin-inhibitor naïve cohort, there will be up to 24 patients, including up to 6 patients from the phase I portion of the study
In the menin-inhibitor exposed cohort, there will be up to 16 patients, including up to 6 patients from the phase I portion of the study
The next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients.
The next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients.
The first cohort of 3 patients will be treated at dose level 1A
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
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