Spots Global Cancer Trial Database for Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
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Trial Identification
Brief Title: Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
Official Title: Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML)
Study ID: NCT03836209
Conditions
Study Description
Brief Summary: 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.
Detailed Description: Approximately one third of patients with AML have a particular change in their leukemia cells (called a mutation) in a gene called FLT3. The presence of a FLT3 mutation can be used to direct treatment options. This is an open-label phase II study. Patients will receive standard chemotherapy of daunorubicin and cytarabine during Induction and high-dose cytarabine during Consolidation. Patients will be randomized to gilteritinib or midostaurin. After approximately 90 patient's complete treatment, a review of the effectiveness of gliteritinib compared to midostaurin will be done. If gilteritinib is not as effective as midostaurin, the study may be stopped. Bone marrow aspirate and biopsy will be done on Day 21 after start of Induction and after Induction to assess response. Patients with a complete response may proceed to consolidation chemotherapy. Another bone marrow aspirate and biopsy will be done after the first cycle of consolidation is complete. Mandatory prescreening bone marrow and/or blood samples are required for FLT3 testing. Any left-over samples will be requested for future research (optional). Mandatory bone marrow samples for research are required after Induction and if patient receives Consolidation, after the first cycle of Consolidation.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
University of Rochester Medical Center, Rochester, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
East Carolina University, Greenville, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
University of Oklahoma Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
LDS Hospital, Salt Lake City, Utah, United States
MultiCare, Spokane, Washington, United States
West Virginia University, Morgantown, West Virginia, United States
University of Wisconsin Clinical Science Center, Madison, Wisconsin, United States
Marshfield Medical Center, Marshfield, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, United States
Contact Details
Name: Selena Luger, MD
Affiliation: University of Pennsylvania
Role: STUDY_CHAIR
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