A Phase 1B Study of Gilteritinib Plus Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia


Full Title

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


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).

Who Can Join

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.


For more information and to see if you can join this study, please contact Dr. Eytan Stein’s office at 646-608-3749.




Phase I (phase 1)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID