A Phase II Study of Standard Chemotherapy with either Gilteritinib or Midostaurin to Treat FLT3-Mutated Acute Myeloid Leukemia

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Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML)

Purpose

A mutation in a gene called FLT3 can make acute myeloid leukemia (AML) cells grow quickly and affect how they respond to treatment. The drug midostaurin is approved by the U.S. Food and Drug Administration (FDA) to treat newly diagnosed AML with the FLT3 mutation when given with the chemotherapy drugs daunorubicin and cytarabine.

Another drug called gilteritinib is also useful against FLT3-mutated AML. It works by blocking the FLT3 protein, which may help stop leukemia cells from growing and also enable daunorubicin and cytarabine to work better. The FDA has approved gilteritinib to be used in patients with FLT3-mutated AML that has come back or continued to grow despite prior treatment, but its use in newly diagnosed patients is considered investigational.

In this study, patients newly diagnosed with FLT3-mutated AML will be randomly assigned to receive daunorubicin and cytarabine plus either gilteritinib or midostaurin, and researchers will compare the two groups. Daunorubicin and cytarabine are given intravenously (by vein) and gilteritinib and midostaurin are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be newly diagnosed with FLT3-mutated AML that has not yet been treated.
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.
  • This study is for patients age 18 to 65.

For more information and to inquire about eligibility for this study, please contact Dr. Ellin Berman at 212-639-7762.

Protocol

20-123

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators