Actively Recruiting
A Study of Revumenib and Mezigdomide in People With Leukemia
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-01-21
52
Participants Needed
10
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Revumenib and Mezigdomide in People With Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 12 years of age or older at the time of signing the informed consent form.
- Participant must weigh at least 40 kg.
- Participant is willing and able to follow the study visit schedule and protocol requirements.
- Participant has relapsed or refractory acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia) after failure of at least one prior therapy.
- Participant has confirmed acute leukemia with detectable NPM1c mutation, KMT2A translocation, or NUP98 translocation.
- Participants in Phase 1 have no prior menin inhibitor treatment requirements.
- Participants in Phase 2, cohort 1 must be menin inhibitor naive.
- Participants in Phase 2, cohort 2 must have prior menin inhibitor treatment.
- At least 60 days must have passed since any allogeneic stem cell transplant, and at least 4 weeks since donor lymphocyte infusion.
- Participant has an ECOG performance status of 0-2 if 18 years or older, Karnofsky score of at least 50 if 16 years or older but under 18, or Lansky score of at least 50 if under 16 years.
- Participant has a white blood cell count less than 25,000/µL at treatment start.
- Participant has adequate organ function including liver enzymes no more than 3 times the upper limit of normal, bilirubin less than 1.5 times the upper limit (with some exceptions), creatinine less than twice the upper limit or adequate kidney function, and heart ejection fraction of 50% or greater.
You will not qualify if you...
- Participants with acute promyelocytic leukemia.
- Participants with isolated myeloid sarcoma.
- Participants who have previously received mezigdomide.
- Participants with life-threatening complications such as uncontrolled bleeding, severe pneumonia, disseminated intravascular coagulation, or tumor lysis syndrome.
- Participants with other conditions that increase risk or make study participation inappropriate.
- Participants with another active malignancy that would affect study results.
- Participants who received other anti-leukemia therapy within 5 half-lives or 14 days before study treatment unless toxicity has resolved.
- Participants with active grade 2 or higher graft versus host disease requiring systemic treatment.
- Participants with significant active heart disease within 6 months before treatment.
- Participants with a QTc interval of 450 ms or higher without special approval.
- Participants with active HIV, hepatitis B, or hepatitis C infections.
- Participants with swallowing or gastrointestinal absorption problems.
- Participants with uncontrolled systemic infections.
- Participants using strong or moderate CYP3A4 inhibitors or inducers.
- Participants who used proton pump inhibitors less than 2 weeks before treatment.
- Pregnant or lactating female participants.
- Participants not willing to use contraception during and after the study as required.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
City of Hope Cancer Center (Data collection only)
Duarte, California, United States, 91010
Not Yet Recruiting
2
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
9
University of North Carolina (Data Collection Only)
Chapel Hill, North Carolina, United States, 27514
Not Yet Recruiting
10
MD Anderson Cancer Center (Data Collection Only)
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
E
Eytan Stein, MD
CONTACT
N
Neerav Shukla, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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