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Two drugs, mezigdomide and revumenib, to treat acute leukemia that is mutated and has come back (relapsed) or not gotten better with treatment (refractory) in children and adults

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12 and older

Phase 1, Phase 2

10 Locations

NCT07356154

Clinical Trial Goal


To find out:
  • The highest dose of mezigdomide and revumenib that's safe to give 
  • If the combination of mezigdomide and revumenib is safe and works well to treat acute leukemia that is mutated and has relapsed or is refractory in children and adults

You may be able to join this trial if you:


  • Are 12 years old or older
  • Have acute leukemia that has relapsed or is refractory. Some examples include:
    • Acute lymphoblastic leukemia (ALL)
    • Acute myeloid leukemia (AML)
    • Mixed phenotype acute leukemia (MPAL)
  • Have cancer cells with one of the following mutations or rearrangements:
    • KMT2A+
    • NPMI+
    • NUP98+
  • Do not have acute promyelocytic leukemia (APL)
  • Have not been treated with mezigdomide
  • Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 2 months 
  • Do not have active graft-versus-host-disease (GVHD)
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Mezigdomide is an immunomodulatory drug that doctors think will help fight cancer cells.
Revumenib is a menin inhibitor that blocks interaction between the menin protein and the KMT2A protein. 

You’ll get:
  • Mezigdomide– The dose you'll get depends on when you start the trial and how safe it has been
  • Revumenib – The dose you'll get depends on when you start the trial and how safe it has been

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for about 1 year.

The Food and Drug Administration (FDA) has not yet approved mezigdomide. 

Contacts


Eytan Stein, MD, 646-608-3749, SteinE@mskcc.org

Neerav Shukla, MD, 212-639-5158, shuklan@MSKCC.ORG

Locations

City of Hope Cancer Center (Data collection only)NOT_YET_RECRUITING

Duarte, California
Ibrahim Aldoss, MD, 877-814-1610

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

Basking Ridge, New Jersey
Eytan Stein, MD, 646-608-3749

Memorial Sloan Kettering Bergen (All Protocol Activities)RECRUITING

Montvale, New Jersey
Eytan Stein, MD, 646-608-3749

Memorial Sloan Kettering Monmouth (All Protocol Activities)RECRUITING

Middletown, New Jersey
Eytan Stein, MD, 646-608-3749

Memorial Sloan Kettering Cancer Center (All Protocol Activities)RECRUITING

New York, New York
Eytan Stein, MD, 646-608-3749

Memorial Sloan Kettering Nassau (All Protocol Activities)RECRUITING

Rockville Centre, New York
Eytan Stein, MD, 646-608-3749

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

Commack, New York
Eytan Stein, MD, 646-608-3749

Memorial Sloan Kettering Westchester (Limited Protocol Activities)RECRUITING

Harrison, New York
Eytan Stein, MD, 646-608-3749

University of North Carolina (Data Collection Only)NOT_YET_RECRUITING

Chapel Hill, North Carolina
Joshua Zeidner, MD, 984-974-8763

MD Anderson Cancer Center (Data Collection Only)NOT_YET_RECRUITING

Houston, Texas
Ghayas Issa, MD, 713-792-6161

ClinicalTrials.gov record


NCT07356154. First posted on Jan 21

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