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A drug, SNDX-5613, alone or with the drug cobicistat, to treat acute leukemia with a KMT2A translocation or an NPM1 mutation that has come back (relapsed) or has not gotten better with treatment (refractory)

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Phase 1, Phase 2

16 Locations

NCT04065399

Clinical Trial Goal


To find out:
  • The highest dose of SNDX-5613 that’s safe to give
  • If SNDX-5613 is safe and works well to treat acute leukemia with a KMT2A translocation or an NPM1 mutation that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 1 month old or older
  • Have one of the following diseases that has relapsed or is refractory and there are no more standard treatments available:
    • Acute myeloid leukemia (AML) with a KMT2A translocation (previously called MLL rearrangement)
    • AML with an NPM1c mutation
    • Acute lymphocytic leukemia (ALL) with a KMT2A translocation
    • Acute biphenotypic leukemia with a KMT2A translocation
    • Acute leukemia with a NUP98 rearrangement
  • Do not have acute promyelocytic leukemia (APL)
  • Have not had total body irradiation (TBI) in the last 2 months
  • Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 2 months
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Cobicistat is a small molecule inhibitor that blocks CYP3A in certain cells.
SNDX-5613 is a small molecule inhibitor that blocks MLL1 and Menin in certain cells.

You’ll get:
  • SNDX-5613 – 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
  • Cobicistat – A pill that you take by mouth 1 time each day. The clinical trial doctors will decide who gets this based on what's best for your health and when you joined the trial

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You’ll have biopsies to see how well treatment is working. The clinical trial doctors will check your health for about 5 years.

The Food and Drug Administration (FDA) not yet approved SNDX-5613. The FDA has approved cobicistat to treat human immunodeficiency virus (HIV) infection.

Contacts


David Tamang, 781.419.1400, dtamang@syndax.com

Locations

City of Hope Comprehensive Cancer CenterRecruiting

Duarte, California
Manjyot Nanhwan, mnanhwan@coh.org

Stanford Cancer InstituteRecruiting

Palo Alto, California
Panayota Rigas, prigas@stanford.edu

Moffitt Cancer CenterCompleted

Tampa, Florida

Florida Cancer Specialists and Research InstituteRecruiting

Sarasota, Florida
Terri Peterson, RN, tpeterson@flcancer.com

Children's Healthcare of AtlantaRecruiting

Atlanta, Georgia
Aflac Cancer & Blood Disorders Center Referral, aflacdevtreferral@choa.org

Emory Winship Cancer InstituteRecruiting

Atlanta, Georgia
Shannon Gleason, MLS, CCRC, 404-778-4334, shannon.gleason@emory.edu

The University of Chicago Medical CenterRecruiting

Chicago, Illinois
Howie Weiner, CCRP, 773-702-2084

Dana Farber Cancer InstituteRecruiting

Boston, Massachusetts
Contacts:

Washington University in St. Louis School of MedicineRecruiting

Saint Louis, Missouri
Contacts:

Memorial Sloan Kettering Cancer CenterRecruiting

New York, New York
Kait Tkachuk, 646-608-2783, tkachukk@mskcc.org

Montefiore Medical CenterRecruiting

New York, New York
Contacts:

Ohio State UniversityRecruiting

Columbus, Ohio
Molly Brandenburg, 614-366-7951, molly.brandenburg@osumc.edu

Oregon Health & Science UniversityRecruiting

Portland, Oregon
Clinical Trials Information Line, 503-494-1080, trials@ohsu.edu

University of PennsylvaniaRecruiting

Philadelphia, Pennsylvania
Robin E Blauser, BSN RN, 215-662-2870, Robin.Blauser@pennmedicine.upenn.edu

The University of Texas MD Anderson Cancer CenterRecruiting

Houston, Texas
Ghayas Issa, MD, gcissa@mdanderson.org

Huntsman Cancer Institute at the University of UtahRecruiting

Salt Lake City, Utah
Contacts:

ClinicalTrials.gov record


NCT04065399

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