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A drug, revumenib, in combination with standard chemotherapy (chemo), to treat acute myeloid leukemia (AML) that has not yet been treated

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18 - 75

Phase 1

25 Locations

NCT06226571

Clinical Trial Goal


To find out:
  • The highest dose of revumenib that’s safe to give with standard chemo
  • If revumenib with standard chemo is safe and works well to treat AML that has not yet been treated

You may be able to join this trial if you:


  • Are 18 - 75 years old
  • Have AML that has not yet been treated
  • Have cancer cells with one of the following mutations. Your doctor can tell you this:
    • KMT2Ar
    • NPM1c
    • NUP98r 
  • Do not have acute promyelocytic leukemia
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Cytarabine, daunorubicin and idarubicin are chemo drugs that block the growth of cancer cells.
Revumenib is a menin inhibitor that blocks interaction between the menin protein and the KMT2A protein. 

You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
  • Cytarabine and daunorubicin or idarubicin (standard chemo) – Given as intravenous (IV) infusions 
  • Revumenib - A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You may be eligible to continue treatment with a blood or marrow transplant (BMT) if you are eligible and have an available donor. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 3 years. 

The Food and Drug Administration (FDA) has approved all of the drugs used in this trial to treat acute leukemia. Using them together in this way is new and unproven. 

Contacts


Syndax Pharmaceuticals, 781-419-1400, clinicaltrials@syndax.com

Locations

City of Hope Medical CenterRECRUITING

Duarte, California
Wirlen Elame, 626-218-7451, welame@coh.org

UCLA Medical HematologyRECRUITING

Burbank, California
Gary Schiller, MD, gschiller@mednet.ucla.edu

AdventHealth Blood & Marrow Transplant CenterRECRUITING

Orlando, Florida
Brian Parkin, MD, brian.parkin.md@adventhealth.com

Tampa General HospitalRECRUITING

Tampa, Florida
David Swoboda, MD, dswoboda@tgh.org

Emory Winship Cancer InstituteRECRUITING

Atlanta, Georgia
William Blum, MD, wblum@emory.edu

University of ChicagoRECRUITING

Chicago, Illinois
Michael Thirman, MD, mthirmana@uchicago.edu

Norton Cancer Institute, St. Matthews CampusRECRUITING

Louisville, Kentucky
Don Stevens, MD, don.stevens@nortonhealthcare.org

Beth Israel Deaconess Medical CenterRECRUITING

Boston, Massachusetts
Margaret Michaelian, mmichae1@bidmc.harvard.edu

University of MichiganRECRUITING

Ann Arbor, Michigan
Dale Bixby, MD, dbixby@umich.edu

Allina Health Cancer InstituteRECRUITING

Minneapolis, Minnesota
Fiona He, MD, fiona.he@allina.com

Washington University School of MedicineRECRUITING

St Louis, Missouri
Dr. John DiPersio, jdipersi@wustl.edu

Institution name: Northwell Health-BranyRECRUITING

Lake Success, New York
David Chitty, MD, DChitty@northwell.edu

Memorial Sloan Kettering Cancer CenterRECRUITING

New York, New York
Eytan Stein, MD, steine@mskcc.org

SUNY Upstate Medical UniversityRECRUITING

Syracuse, New York
Teresa Gentile, MD, gentilet@upstate.edu

University of Rochester Medical CenterRECRUITING

Rochester, New York
Jozal Moore, MD, jozal_moore@urmc.rochester.edu

Atrium Health Wake Forest Baptist Medical CenterRECRUITING

Winston-Salem, North Carolina
Timoth Pardee, MD, tspardee@wakehealth.edu

East Carolina UniversityRECRUITING

Greenville, North Carolina
Darla Liles, MD, Lilesd@ecu.edu

Cleveland Clinic FoundationRECRUITING

Cleveland, Ohio
Moaath Mustafa Ali, MD, MPH, mustafm8@ccf.org

Oregon Health and Science University- Center for Hematologic MalignanciesRECRUITING

Portland, Oregon
Elie Traer, MD, traere@ohsu.edu

UPMC Hillman Cancer CenterRECRUITING

Pittsburgh, Pennsylvania
Annie lm, MD, imap@upmc.edu

MUSC Hollings Cancer Center (HCC)RECRUITING

Charleston, South Carolina
Praneeth Baratam, MD, baratamp@musc.edu

Baylor University Medical CenterRECRUITING

Dallas, Texas
Bradley Christensen, MD, Bradley.Christensen@usoncology.com

The University of Texas, MD Anderson Cancer CenterRECRUITING

Houston, Texas
Ghayas C. Issa, MD, GCIssa@mdanderson.org

LDS Hospital - Intermountain HealthcareRECRUITING

Salt Lake City, Utah
Bradley Hunter, MD, brad.hunter@imail.org

West Virginia UniversityRECRUITING

Morgantown, West Virginia
Carl Shultz, MD, carl.shultz@wvumedicine.org

ClinicalTrials.gov record


NCT06226571. First posted on 1/26/24

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