A Phase 1b Multi-center Study of the FLT3 Inhibitor Gilteritinib in Combination With the IDH1 Inhibitor Ivosidenib or the IDH2 Inhibitor Enasidenib for Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Have Co-occurring FLT3/IDH1 or FLT3/IDH2 Mutations GILTERITINIB COMBINATION THERAPY
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What's the purpose of this trial?

In this study, researchers want to find the best doses of 2 different drug combinations. This study is for people with acute myeloid leukemia (AML) that keeps growing even after treatment. You also must have changes (mutations or variants) in the FLT3 gene, and in either the IDH1 or IDH2 genes. The FLT3 gene can cause cancer cells to grow. The IDH1 and IDH2 genes cause low blood cell counts.

If you join this study, you will get gilteritinib and either ivosidenib or enasidenib. Gilteritinib targets cells that make the FLT3 protein, which may cause cancer cells to die. Ivosidenib blocks the mutated IDH1 protein. Enasidenib blocks the mutated IDH2 protein, which raises blood cell counts. All 3 medications are taken orally (by mouth).

This trial is currently open and accepting patients.


You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

To join this study, there are a few conditions. You must:

  • Have AML that came back or keeps growing even after treatment.
  • Have mutations in the FLT3 gene, and in either the IDH1 or IDH2 genes.
  • Be age 18 or older.
  • You may join this study even if you need help taking care of yourself. You may also join even if you are in a bed or chair for more than half the time you’re awake.

Additional Trial Information

Phase 1

Enrollment: 36 patients (estimated)

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Trial Locations

All Trial Locations

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New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Monmouth

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Commack

Commack, NY

Open and Accepting

Memorial Sloan Kettering Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Westchester

West Harrison, NY

Open and Accepting
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