Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
Not yet recruiting
Astellas Pharma Inc
Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and
65 will be randomized to receive gilteritinib or midostaurin during induction and
consolidation. Patients will also receive standard chemotherapy of daunorubicin and
cytarabine during induction and high-dose cytarabine during consolidation.
Gilteritinib, is an oral drug that works by stopping the leukemia cells from making the FLT3
protein. This may help stop the leukemia cells from growing faster and thus may help make
chemotherapy more effective. Gilteritinib has been approved by the Food and Drug
Administration (FDA) for patients who have relapsed or refractory AML with a FLT3 mutation
but is not approved by the FDA for newly diagnosed FLT3 AML, and its use in this setting is
Midostaurin is an oral drug that works by blocking several proteins on cancer cells,
including FLT3 that can help leukemia cells grow. Blocking this pathway can cause death to
the leukemic cells. Midostaurin is approved by the FDA for the treatment of FLT3 AML.
The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in
patients receiving standard combination chemotherapy for FLT3 AML.
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