ILEU19039 / PrECOG / Kristen O'DwyerResearch Question:
How do gilteritinib and midostaurin compare in patients receiving standard combination
chemotherapy for FLT3 acute Myeloid Leukemia?
Basic Study Information
Purpose:Location: University of Rochester Medical Center
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 considered investigational.
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.
Study Reference #: ILEU19039
Lead Researcher (Principal Investigator)
Study Contact InformationStudy Coordinator: Lauren Mitchell
Additional Study Details
Trial Not Found
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