A Study of Revumenib and Mezigdomide for Leukemia
This study is testing a combination of two drugs, revumenib and mezigdomide, for people with certain types of acute leukemia that have come back or not responded to previous treatments (relapsed or refractory acute leukemia). Specifically, it's for those with KMT2A-r, NUP98-r, and NPM1-m acute leukemias. The main goal is to find the safest dose of this drug combination. You may be able to join if you are at least 12 years old, weigh at least 40 kg, and have relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype leukemia. The study plans to enroll 52 participants, but its current status is unclear.
- Study design
- This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 52 participants.
- What's involved
- You must be willing and able to follow the study visit schedule and other requirements.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, Maximum Tolerated Dose, is measured at 1 year.
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NCT07356154
A Study of Revumenib and Mezigdomide in People With Leukemia
Recruiting
PHASE1Ages 12+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~52 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:RevumenibMezigdomide
At a glance
Recruiting sites
7 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Maximum Tolerated Dose
Measured over 1 year
Conditions
Where it's being run
10 sites across 5 statesNew York4
New Jersey3
California1
North Carolina1
Texas1
Study leadership
- Kuo-Kai Chin, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participant must be ≥ 12 years of age at the time of signing the informed consent form (ICF).
Participant must weigh at least 40 kg
Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
Participant has relapsed/refractory acute leukemia defined acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia after as failure of at least 1 prior line of therapy (can be either primary refractory disease or progression during or after treatment)
Participant has confirmed acute leukemia with detectable NPM1c, KMT2A translocation, or NUP98 translocation.
Regarding prior treatment with a menin inhibitor:
Regarding prior alloSCT, at 60 days must have elapsed from day of transplant and at least 4 weeks must have elapsed from first dose of donor lymphocyte infusion.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (if aged ≥18 years); Karnofsky Performance Scale of ≥50 (if aged ≥16 years and \<18 years); Lansky Performance Score of ≥50 (if aged \<16 years).
Participant must have a WBC count \<25,000/μL at the time of initiation of study drug (leukapheresis may be performed and/or hydroxyurea may be administered to decrease the WBC count to \<25,000/μL).
Participant has adequate organ function defined as:
Exclusion
Participants with acute promyelocytic leukemia
Participants with isolated myeloid sarcoma
Participants who have previously received mezigdomide.
Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.
Participant has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.
Participants with concurrent other malignancy that will confound interpretation of study endpoints.
Participants who have received other anti-leukemia therapy within 5 half-lives of the agent or 14 days, whichever is sooner, prior to study treatment and if toxicity related to said agent has not resolved; exceptions of acceptable concomitant therapies are listed below
Participants with active graft versus host disease (GVHD) of grade 2 or higher requiring systemic treatment. Skin GVHD solely managed with topical corticosteroids would not be exclusionary.
Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and/or stroke.
Participant has QTc interval (i.e., Fridericia's correction \[QTcF\]) ≥ 450 ms (mean of triplicate ECG) or other factors that increase the risk of QT prolongation or ventricular arrhythmic events (e.g., family history of long QT interval syndrome). Patients with a QTcF over 450 ms due to a bundle branch block or a pacemaker may participate in the study with approval of the study principal investigator.
Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).
Participant with active use of strong or moderate CYP3A4 inhibitors or strong CYP3A4 inducers. Details reviewed in Appendix B.
Participant with use of proton pump inhibitors less than 2 weeks prior to initiating treatment
Female participant who is pregnant or lactating. Male or female participants not willing to comply with contraceptive requirements, which include 4 months of contraception after last dose of revumenib for males and 6 months for females. Additional contraception details reviewed in Appendix D.
What this trial measures
- Phase I: Maximum Tolerated Dose1 year
Maximum Tolerated Dose/MTD is defined as the highest dose level in which 6 participantshave been treated with at most 1 instance of dose limiting toxicities/DLT.