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A drug, AOH1996, in combination with azacitidine and venetoclax, to treat acute myeloid leukemia (AML) that has come back (relapsed) or not gotten better with treatment (refractory)

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18 and older

Phase 1

1 Location

NCT06763341

Clinical Trial Goal


To find out:
  • The highest dose of AOH1996 that's safe to give
  • If the combination of AOH1996, azacitidine and venetoclax is safe and works well to treat AML that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have AML that has relapsed or is refractory
  • Do not have acute promyelocytic leukemia
  • Have not had an allogeneic (cells from a donor) or autologous (your own cells) blood or marrow transplant (BMT) in the last 3 months
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


AOH1996 is a small molecule inhibitor that targets proliferating cell nuclear antigen (PCNA) on certain cells.
Azacitidine is a drug that blocks the growth of cancer cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.

You’ll get treatment in cycles that last 1 month. In each cycle, you'll get: 
  • AOH1996 – A pill that you take by mouth 2 times each day
  • Azacitidine –  Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Venetoclax – 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'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 2 years. 

The Food and Drug Administration (FDA) has not yet approved AOH1996. 

Locations


City of Hope Medical CenterRECRUITING

Duarte, California
Amanda Blackmon, 626-218-2405, ablackmon@coh.org

ClinicalTrials.gov record


NCT06763341. First posted on Jan 8

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