A Study of Revumenib and Mezigdomide in People With Leukemia

Part of paid clinical trials in Duarte, California.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07356154
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Revumenib — DRUG
    Revumenib is a novel menin inhibitor
  • Mezigdomide — DRUG
    Mezigdomide (CC-92480) is an investigational CELMoD.

Study Details

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.

Key Dates

Start date
Jan 16, 2026
Status verified
Jan 2026
Primary completion
Jan 16, 2029
Completion
Jan 16, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1A
    The first cohort of 3 patients will be treated at dose level 1A
  • Experimental: Phase 1B
    The next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients.
  • Experimental: Phase 1C
    The next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients.
  • Experimental: Phase 2: Menin Inhibitor Naive Cohort
    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
  • Experimental: Phase 2: Menin Inhibitor Exposed Cohort
    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

Primary Outcome Measure

Phase I: Maximum Tolerated Dose [ Time Frame: 1 year ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
City of Hope Cancer Center (Data collection only)DuarteCalifornia91010
Ibrahim Aldoss, MD
877-814-1610
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
Eytan Stein, MD
646-608-3749
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Eytan Stein, MD
646-608-3749
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Eytan Stein, MD
646-608-3749
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)CommackNew York11725
Eytan Stein, MD
646-608-3749
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Eytan Stein, MD
646-608-3749
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Eytan Stein, MD
646-608-3749
Memorial Sloan Kettering Nassau (All Protocol Activities)Rockville CentreNew York11553
Eytan Stein, MD
646-608-3749
University of North Carolina (Data Collection Only)Chapel HillNorth Carolina27514
Joshua Zeidner, MD
984-974-8763
MD Anderson Cancer Center (Data Collection Only)HoustonTexas77030
Ghayas Issa, MD
713-792-6161

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope Cancer Center (Data collection only)· Duarte, CAMemorial Sloan Kettering at Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (All Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (All Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NY

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