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Two drugs, decitabine and quizartinib to treat acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)

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18 and older

Phase 1, Phase 2

1 Location

NCT03661307

Clinical Trial Goal


To find out if the combination of decitabine and quizartinib is safe and works well to treat AML or MDS

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have AML or MDS that has come back (relapsed) or has not gotten better with treatment (refractory)
  • Have leukemia cells with FLT-ITD mutation. Your doctor can tell you this
  • Have not had more than 3 different treatments for AML or MDS
  • Do not have acute promyelocytic leukemia
  • Agree to have other standard tests done to see if you can be in the clinical trial

If you are 60 years old or older and have untreated AML or MDS, you may also be able to join this trial.

Trial Details


Decitabine is a drug that blocks growth of cancer cells.
Quizartinib is a small molecule inhibitor that blocks FLT3 in certain cells.

You’ll get:
  • Decitabine – Given as an intravenous (IV) infusion 1 time each day for the first 10 days of each month. Each infusion takes about 1 hour
  • Quizartinib – A pill that you take by mouth each day

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 as long as you’re in the trial.

The Food and Drug Administration (FDA) has approved decitabine to treat MDS and quizartinib for leukemia with a FLT3 mutation

Contacts


Musa Yilmaz, 713-745-9945, myilmaz@mdanderson.org

Locations


M D Anderson Cancer CenterRECRUITING

Houston, Texas
Musa Yilmaz, MD, 713-745-9945, myilmaz@mdanderson.org

ClinicalTrials.gov record


NCT03661307. First posted on 9/7/18

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