Gilteritinib Combination Therapy

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

What's the purpose of the trial?

The researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed/refractory AML with FLT3/IDH1 or FLT3/IDH2 gene mutations. The researchers will also look for the highest dose of the combination of gilteritinib with ivosidenib or enasidenib that causes few or mild side effects. When the highest safe dose is found, they will test that dose in new groups of participants.
Trial status

Accepting patients

Phase
Phase 1
Enrollment
36
Last Updated
4 months ago

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Participating Centers

There are 7 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Enasidenib is an IDH2 inhibitor that is FDA approved to treat acute myeloid leukemia in patients with a specific IDH2 mutations, and being studied for use in other blood cancers. 
  • Gilteritinib is a tyrosine kinase inhibitor that is approved for acute myeloma leukemia patients who are FLT-3 positive. It is currently being studied for use in several different indications.
  • Ivosidenib is a small molecule inhibitor that is approved for use in acute myeloid leukemia and cholangiocarcinoma.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

Gilteritinib + Ivosidenib

Accepting patients

Gilteritinib + Enasidenib

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