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A drug, rezatapopt, in combination with azacitidine, to treat acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with TP53Y220C mutation (TP53Y220C+) that has come back (relapsed) or not gotten better with treatment (refractory)

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18 and older

Phase 1

1 Location

NCT06616636

Clinical Trial Goal


To find out:
  • The highest dose of rezatapopt that's safe to give with azacitidine
  • If rezatapopt is safe and works well to treat TP53Y220C+ AML or MDS that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have AML or MDS that has relapsed or is refractory
  • Have cancer cells with TP53Y220C mutation (TP53Y220C+). Your doctor can tell you this
  • 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


Azacitidine is a drug that blocks the growth of cancer cells.
Rezatapopt is a small molecule reactivator that binds to P53Y220C. 

You’ll get:
  • Azacitidine – Given as intravenous (IV) infusions for 1 week
  • Rezatapopt –  A pill that you take by mouth 1 time each day

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 approved azacitidine to treat AML and MDS. The FDA has not yet approved rezatapopt. 

Contacts


Courtney DiNardo, MD, (713) 794-1141, cdinardo@mdanderson.org

Locations


The University of Texas MD Anderson Cancer CenterRECRUITING

Houston, Texas
Courtney DiNardo, MD, 713-794-1141, cdinardo@mdanderson.org

ClinicalTrials.gov record


NCT06616636. First posted on 9/27/24

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