Actively Recruiting
A Phase 1/2 Study of the Menin Inhibitor Revumenib With the CELMod Mezigdomide in Relapsed/Refractory KMT2A-rearranged, NPM1-mutant, and NUP98-rearranged Acute Leukemias
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-01-21
52
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of two drugs, mezigdomide and revumenib, to see if this treatment is safe for people aged 12 and older with relapsed or refractory acute leukemias that have specific genetic changes (KMT2A rearranged, NUP98 rearranged, or NPM1 mutated). This study is a phase 1/2 clinical trial focusing on patients whose leukemia did not respond to at least one prior treatment. The research is sponsored by Memorial Sloan Kettering Cancer Center. Participants will receive revumenib, a menin inhibitor, together with mezigdomide, an investigational CELMoD drug. The study includes several groups: initial dose-finding groups in phase 1 and two phase 2 groups based on previous exposure to menin inhibitors. Small groups of patients will be treated at a time, with careful monitoring for side effects before enrolling more participants. The trial includes both patients who have never received menin inhibitors and those who have. During the study, participants will be closely monitored through regular visits to assess safety, organ function, and response to treatment. Researchers will measure the highest dose that can be tolerated over one year. Participants must meet specific health criteria and will undergo blood tests, heart function tests, and genetic testing. The study will last until January 2029, with ongoing assessments to ensure participant safety and gather important information about the treatment.
CONDITIONS
Brief 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 must be willing and able to follow the study visit schedule and other protocol requirements.
- Participant has relapsed or refractory acute leukemia, including acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia, after failing at least one prior therapy.
- Participant has confirmed acute leukemia with detectable NPM1c mutation, KMT2A translocation, or NUP98 translocation as determined by validated testing.
- For Phase 1, no prior menin inhibitor treatment required.
- For Phase 2, cohort 1: menin inhibitor naive (no prior menin inhibitor treatment).
- For Phase 2, cohort 2: menin inhibitor exposed (previous menin inhibitor treatment).
- At least 60 days must have passed since any prior allogeneic stem cell transplant, and at least 4 weeks since donor lymphocyte infusion.
- Participant has an ECOG performance status of 0-2 if aged 18 or older; Karnofsky score of 50 or higher if aged 16 to under 18; Lansky score of 50 or higher if under 16.
- White blood cell count less than 25,000/µL at start of study drug.
- Adequate organ function including liver enzymes, bilirubin, kidney function, and heart function as specified.
You will not qualify if you...
- Participants with acute promyelocytic leukemia.
- Participants with isolated myeloid sarcoma.
- Participants who have previously received mezigdomide.
- Participants with immediate life-threatening or severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.
- Participants with any condition that increases risk or makes study participation inappropriate as judged by the investigator.
- Participants with concurrent other malignancies that would affect study results.
- Participants who received other anti-leukemia therapy within 5 half-lives or 14 days before study treatment unless exceptions apply.
- Participants with active graft versus host disease grade 2 or higher requiring systemic treatment.
- Participants with significant active cardiac disease within 6 months prior to study treatment.
- Participants with prolonged QTc interval or other risk factors for heart rhythm problems.
- Participants with active infections such as HIV, hepatitis B, or hepatitis C.
- Participants with conditions limiting oral drug absorption.
- Participants with active uncontrolled systemic infections.
- Participants using strong or moderate CYP3A4 inhibitors or inducers.
- Participants who used proton pump inhibitors less than 2 weeks before starting treatment.
- Pregnant or lactating females or those unwilling to use contraception as required.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression or discontinuation
Participants receive investigational drugs Revumenib and Mezigdomide to treat relapsed or refractory acute leukemia.
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
N
Neerav Shukla, MD
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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