Spots Global Cancer Trial Database for A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML
Study ID: NCT02997202
Conditions
Study Description
Brief Summary: The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.
Detailed Description: Participants with FLT3/ITD AML in first morphologic complete remission (CR1) undergoing allogeneic hematopoietic stem cell transplant (HCT) will be randomized to receive gilteritinib or placebo 30 to 90 days after HCT for a two year period. Participants will be stratified according to: 1) conditioning regimen intensity (myeloablative vs. reduced intensity/non-myeloablative), 2) time from first day of hematopoietic cell infusion to randomization (30-60 days vs. 61-90 days) and 3) presence vs absence of or unknown minimal residual disease (MRD) from the most recent pre-registration bone marrow (BM) aspirate.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Mayo Clinic, Phoenix, Arizona, United States
Virginia G Piper Cancer Center, Scottsdale, Arizona, United States
University of California San Francisco, San Francisco, California, United States
Stanford University, Stanford, California, United States
Yale University School of Medicine, New Haven, Connecticut, United States
University of Florida, Gainesville, Florida, United States
University of Miami, Miami, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
Northside, Atlanta, Georgia, United States
Augusta University, Augusta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Indiana Blood and Marrow Transplant, Indianapolis, Indiana, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
University of Maryland Medical Systems, Baltimore, Maryland, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts, Worcester, Massachusetts, United States
Karmanos Cancer Center, Detroit, Michigan, United States
University of Minnesota School of Medicine, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Memorial Sloan Kettering, New York, New York, United States
Weill Cornell Medical Center, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
University Hospitals of Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University, The, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Baylor College of Medicine, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Intermountain BMT, Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
West Virginia University Hospital, Morgantown, West Virginia, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Site AU61001, Liverpool, , Australia
Site AU61002, Melbourne, , Australia
Site AU61004, Westmead, , Australia
Site BE32003, Bruxelles, , Belgium
Site BE32004, Gent, , Belgium
Site CA15004, Hamilton, , Canada
Site CA15003, Montreal, , Canada
Site DK45002, Arhus, , Denmark
Site DK45001, Copenhagen, , Denmark
Site FR33007, Lille, , France
Site FR33004, Lyon, , France
Site FR33005, Paris, , France
Site FR33008, Pessac, , France
Site FR33010, Vandoeuvre-Les-Nancy, , France
Site DE49002, Düsseldorf, , Germany
Site DE49003, Halle (Saale), , Germany
Site DE49005, Hamburg, , Germany
Site DE49006, Köln, , Germany
Site DE49007, Mainz, , Germany
Site DE49004, Münster, , Germany
Site GR30004, Athens, , Greece
Site GR30003, Rio, , Greece
Site GR30001, Thessaloniki, , Greece
Site IT39005, Bergamo, , Italy
Site IT39006, Bologna, , Italy
Site IT39009, Genova, , Italy
Site IT39002, Milano, , Italy
Site IT39007, Milano, , Italy
Site IT39011, Pescara, , Italy
Site IT39003, Roma, , Italy
Site IT39004, Udine, , Italy
Site JP81014, Anjo, Aichi, Japan
Site JP81011, Nagoya, Aichi, Japan
Site JP81018, Sapporo, Hokkaido, Japan
Site JP81021, Kobe, Hyogo, Japan
Site JP81012, Nishinomiya, Hyogo, Japan
Site JP81002, Isehara, Kanagawa, Japan
Site JP81007, Yokohama, Kanagawa, Japan
Site JP81010, Sendai, Miyagi, Japan
Site JP81006, Suita, Osaka, Japan
Site JP81008, Shimotsuke, Tochigi, Japan
Site JP81013, Bunkyo-ku, Tokyo, Japan
Site JP81004, Chuo-ku, Tokyo, Japan
Site JP81016, Minato-ku, Tokyo, Japan
Site JP81020, Shinjuku-ku, Tokyo, Japan
Site JP81001, Fukuoka, , Japan
Site JP81003, Fukuoka, , Japan
Site JP81015, Kyoto, , Japan
Site JP81017, Okayama, , Japan
Site JP81005, Osaka, , Japan
Site KR82001, Seoul, , Korea, Republic of
Site KR82002, Seoul, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82004, Seoul, , Korea, Republic of
Site KR82005, Seoul, , Korea, Republic of
Site NZ64002, Christchurch, , New Zealand
Site NZ64001, Grafton, , New Zealand
Site PL48004, Warszawa, , Poland
Site ES34004, Barcelona, , Spain
Site ES34005, Barcelona, , Spain
Site ES34006, Salamanca, , Spain
Site ES34007, Santander, , Spain
Site ES34002, Valencia, , Spain
Site TW88603, Taichung, , Taiwan
Site TW88602, Taipei, , Taiwan
Site TW88605, Taoyuan, , Taiwan
Site GB44010, Birmingham, , United Kingdom
Site GB44003, Bristol, , United Kingdom
Site GB44009, Glasgow, , United Kingdom
Site GB44004, London, , United Kingdom
Site GB44002, Manchester, , United Kingdom
Site GB44001, Sutton, , United Kingdom
Contact Details
Name: Senior Medical Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR
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