Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 70 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 combination chemotherapy for FLT3 AML.

Key facts

Study ID

NCT03836209

Run by

PrECOG, LLC.

People needed

181

Starts

2019-12-06

Expected to finish

2026-06-30

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

Where it is running

• HonorHealth Research Institute — Scottsdale, Arizona, United States
• University of California, San Francisco-Fresno (University Oncology Associates) — Clovis, California, United States
• UCLA — Los Angeles, California, United States
• Kaiser Permanente Oakland — Oakland, California, United States
• UC Irvine Health — Orange, California, United States
• Kaiser Permanente Roseville — Roseville, California, United States
• Kaiser Permanente Santa Clara — Santa Clara, California, United States
• Mayo Clinic- Jacksonville, FL — Jacksonville, Florida, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Franciscan Health Indianapolis — Indianapolis, Indiana, United States
• University of Kentucky Markey Cancer Center — Lexington, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• St. Joseph's Mercy Hospital — Ann Arbor, Michigan, United States
• Mayo Clinic- Rochester, MN — Rochester, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Atlantic Health Systems/Morristown Medical Center — Morristown, New Jersey, United States
• Northwell Health — Lake Success, New York, United States
• Mount Sinai — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medicine New York Presbyterian Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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