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A drug, DFP-10917, in combination with 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, Phase 2

4 Locations

NCT06382168

Clinical Trial Goal


To find out:
  • The highest dose of DFP-10917 that's safe to give with venetoclax
  • If the combination of DFP-10917 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 autologous (your own cells) or allogeneic (cells from a donor) blood or marrow transplant (BMT)
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


DFP-10917 is a deoxycytidine nucleoside analogue that doctors believe attacks 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: 
  • DFP-10917 – Given as intravenous (IV) infusions continuously for 2 weeks
  • Venetoclax – A pill that you take by mouth 1 time each day for 2 weeks

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 8.5 years.

The Food and Drug Administration (FDA) has not yet approved DFP-10917. 

Contacts


Scott Frank, +81 362311278, sfrank1206@delta-flypharma.co.jp

Locations


UCI Chao Family Comprehensive Cancer CenterRECRUITING

Orange, California
Kiran Naqvi, MD, MPH, 714-456-8000, knaqvi1@hs.uci.edu

Atrium Health Wake Forest Baptist Comprehensive Cancer CenterRECRUITING

Winston-Salem, North Carolina
Timothy Pardee, MD, 336-716-5847, tspardee@wakehealth.edu

University of Vermont Cancer CenterRECRUITING

Burlington, Vermont
Diego Adrianzen Herrera, MD, 802-656-2021, dadrianz@med.uvm.edu

University of Virginia Cancer CenterRECRUITING

Charlottesville, Virginia
Michael Keng, MD, 434-424-1505, mk2pv@uvahealth.org

ClinicalTrials.gov record


NCT06382168. First posted on 4/24/24

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