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LeukemiaPhase 1/2NCT07356154

A Study of Revumenib and Mezigdomide in People With Leukemia

A Phase 1/2 study testing Revumenib and Mezigdomide in people with Leukemia and Acute Leukemia, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Leukemia, Acute Leukemia, Relapse Leukemia
What is being tested?
Revumenib and Mezigdomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
10 sitesUnited States
Study dates
16 Jan 2026to 16 Jan 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • At MSK, NPM1 testing utilizes MSK-REACT, a rapid multi-gene NGS panel used in all new AML diagnoses that is clinically validated by the Laboratory of Diagnostic Molecular Pathology pursuant to the requirements of CLIA'88 and approved by New York State, or MSK-IMPACT, a multi-gene NGS panel, which is authorized by the FDA. At non-MSK sites, NPM1 testing may be performed in local CLIA-certified laboratories using validated clinical assays with capable of detecting NPM1c variants at a frequency of ≥5%. Eligible patients must have an NPM1c (nucleophosmin) exon 12 variant as determined by these assays.
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  • At MSK, KMT2A and NUP98 testing will utilize chromosomal analysis and fluorescence in situ hybridization studies. At non-MSK sites, testing may be performed in local CLIA-certified laboratories using validated clinical assays with performance characteristics sufficient to detect relevant translocations. Eligible patients must have a KMT2A or NUP98 translocation as determined by these assays
  • The patient's chart will be utilized for screening purposes
  • Regarding prior treatment with a menin inhibitor:
  • Participants enrolled in Phase 1 have no requirements regarding prior treatment with a menin inhibitor
  • Participants enrolled in Phase 2, cohort 1, are required to be menin inhibitor naïve (no previous treatment with a menin inhibitor)
  • Participants enrolled in Phase 2, cohort 2, are required to be menin inhibitor exposed (previous treatment received 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 most recent 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:
  • Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.
  • Serum total bilirubin < 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.
  • Serum creatinine < 2 x ULN or estimated glomerular filtration rate 60 mL/min or greater based on local institutional practice for age-appropriate determination (e.g, Schwartz formula for pediatric patients or Cockcroft Gault formula for adults).
  • Adequate cardiac function defined as ejection fraction of ≥ 50% by echocardiogram or multigated acquisition scan.

Who cannot join

  • 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.
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  • 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
  • Prior or ongoing revumenib therapy does not require a washout period prior to study treatment
  • Concomitant cytoreductive therapy in the form of hydroxyurea, corticosteroids, or cytarabine is permitted.
  • Concomitant therapy in the form of intrathecal chemotherapy for CNS treatment, is permitted.
  • Radiation therapy is not permitted except for localized palliative radiation to focal lesions after discussion with the Medical Monitor for patients who have progressed but remain on the study due to perceived clinical benefit per Investigator assessment
  • 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 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.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kuo-Kai Chin, MD contact

646-608-4415

Chin3@mskcc.org

Eytan Stein, MD contact

646-608-3749

SteinE@mskcc.org

10 sites in 1 country

United States10 sites, 10 recruiting

  • Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Kuo-Kai Chin, MD, 646-608-4415

    Recruiting

  • University of North Carolina (Data Collection Only)

    Chapel Hill, North Carolina, 27514

    Joshua Zeidner, MD, 984-974-8763

    Not yet recruiting

  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

    Commack, New York, 11725

    Kuo-Kai Chin, MD, 646-608-4415

    Recruiting

  • City of Hope Cancer Center (Data collection only)

    Duarte, California, 91010

    Ibrahim Aldoss, MD, 877-814-1610

    Not yet recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

    Kuo-Kai Chin, MD, 646-608-4415

    Recruiting

  • MD Anderson Cancer Center (Data Collection Only)

    Houston, Texas, 77030

    Ghayas Issa, MD, 713-792-6161

    Not yet recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748

    Kuo-Kai Chin, MD, 646-608-4415

    Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey, 07645

    Kuo-Kai Chin, MD, 646-608-4415

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

    Kuo-Kai Chin, MD, 646-608-4415

    Recruiting

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Rockville Centre, New York, 11553

    Kuo-Kai Chin, MD, 646-608-4415

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Being tested
Revumenib, Mezigdomide
Keywords
Leukemia, Acute Leukemia, Relapse Leukemia, Refractory Leukemia, Refractory Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia, Memorial Sloan Kettering Cancer Center, 25-229
Medical subject headings
Leukemia, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RevumenibDrug

    Also called SNDX-5613

    Revumenib is a novel menin inhibitor

  • MezigdomideDrug

    Also called CC-92480

    Mezigdomide (CC-92480) is an investigational CELMoD.

Study groups in NCT07356154
Study groupRoleWhat they receive
Phase 1AExperimentalThe first cohort of 3 patients will be treated at dose level 1A
Receives: Drug: Revumenib; Drug: Mezigdomide
Phase 1BExperimentalThe next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients.
Receives: Drug: Revumenib; Drug: Mezigdomide
Phase 1CExperimentalThe next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients.
Receives: Drug: Revumenib; Drug: Mezigdomide
Phase 2: Menin Inhibitor Naive CohortExperimentalIn 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
Receives: Drug: Revumenib; Drug: Mezigdomide
Phase 2: Menin Inhibitor Exposed CohortExperimentalIn 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
Receives: Drug: Revumenib; Drug: Mezigdomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Maximum Tolerated Dose

    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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start16 Jan 2026
  3. Primary completion16 Jan 2029 (estimated)
  4. Study completion16 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07356154
Sponsor's protocol ID
25-229
Status last verified
Oct 2026
First submitted
20 Jan 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Revumenib and Mezigdomide in people with Leukemia and Acute Leukemia, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kuo-Kai Chin, MD (646-608-4415, Chin3@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Maximum Tolerated Dose (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07356154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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