Study Details
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)
Clinicaltrials.gov ID
Astellas Study ID
2215-CL-0304
EudraCT ID
2016-001061-83
Condition
Leukemia - AML
Phase
Phase 3
Age
18 years - N/A
Sex
Female & Male
Product
gilteritinib
Type
Interventional
Trial Dates
Jun 2017 - May 2023
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment number
356
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 summary
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Locations
Site ES34002
Valencia, Spain
University of California, San Diego
La Jolla, United States, 92093
Karmanos Cancer Center
Detroit, United States, 48201
Oregon Health and Science University
Portland, United States, 97239
Site PL48001
Wroclaw, Poland
Site KR82003
Seoul, Republic of Korea
Site JP81001
Fukuoka, Japan
Site GB44009
Glasgow, United Kingdom, G12 0YN
Site BE32001
Liege, Belgium
Site JP81020
Shinjuku-ku, Japan
Site JP81008
Shimotsuke, Japan
Site AU61001
Liverpool, Australia
Site TW88605
Taoyuan, Taiwan, Province of China
Site PL48004
Warszawa, Poland
Site DK45001
Copenhagen, Denmark
Site JP81014
Anjo, Japan
Beth Israel Deaconess Medical Center
Boston, United States, 02215
Site TW88602
Taipei, Taiwan, Province of China
Texas Transplant Institute
San Antonio, United States, 78229
Site GB44004
London, United Kingdom
Site GR30003
Rio, Greece
Site JP81017
Okayama, Japan
Site FR33007
Lille, France
Site FR33002
Toulouse Cedex 9, France
Site DE49009
Stuttgart, Germany
Roswell Park Cancer Institute
Buffalo, United States, 14263
Site FR33010
Vandoeuvre-Les-Nancy, France
Site KR82001
Seoul, Republic of Korea
Massachusetts General Hospital
Boston, United States, 02114
Loyola University Medical Center
Maywood, United States, 60153
Site GR30002
Athens, Greece
Rutgers CINJ
New Brunswick, United States, 08903
University Hospitals of Cleveland Medical Center
Cleveland, United States, 44106
Site PL48003
Krakow, Poland
Site GR30001
Thessaloniki, Greece
Medical College of Wisconsin
Milwaukee, United States, 53226
Site IT39011
Pescara, Italy
Site FR33006
Montpellier Cedex 5, France
Site IT39007
Milano, Italy
Site GB44003
Bristol, United Kingdom
Site KR82002
Seoul, Republic of Korea
University of Nebraska Medical Center
Omaha, United States, 68198
Virginia G Piper Cancer Center
Scottsdale, United States, 85258
Site DE49007
Mainz, Germany
Site ES34005
Barcelona, Spain
Site TW88601
Kaohsiung, Taiwan, Province of China
Johns Hopkins Hospital
Baltimore, United States, 21231
Yale University School of Medicine
New Haven, United States, 06511
University of Virginia
Charlottesville, United States, 22908
Site ES34007
Santander, Spain
Site IT39004
Udine, Italy
University of Pennsylvania
Philadelphia, United States, 19104
Site FR33008
Pessac, France
Site BE32002
Edegem, Belgium
University of North Carolina
Chapel Hill, United States, 27599
Site JP81021
Kobe, Japan
University of Florida
Gainesville, United States, 32610
Site DE49002
Düsseldorf, Germany
Site DE49005
Hamburg, Germany
Site JP81011
Nagoya, Japan
Site FR33009
Marseille, France
Site ES34004
Barcelona, Spain, 08036
Site DE49003
Halle (Saale), Germany
Site JP81016
Minato-ku, Japan
Tufts Medical Center
Boston, United States, 02111
Oncology Hematology Care, Inc
Cincinnati, United States, 45242
Ohio State University, The
Columbus, United States, 43210
Site JP81002
Isehara, Japan
Site JP81018
Sapporo, Japan
Site AU61002
Melbourne, Australia
Site JP81013
Bunkyo-ku, Japan
Huntsman Cancer Institute
Salt Lake City, United States, 84143
Augusta University
Augusta, United States, 30912
Site DE49004
Münster, Germany
University of Wisconsin Hospital and Clinics
Madison, United States, 53792
Site CA15003
Montreal, Canada
Site GB44002
Manchester, United Kingdom
Mayo Clinic
Rochester, United States, 55905
Indiana Blood and Marrow Transplant
Indianapolis, United States, 46237
Site JP81015
Kyoto, Japan
Site IT39002
Milano, Italy
Vanderbilt University Medical Center
Nashville, United States, 37232
Site KR82004
Seoul, Republic of Korea
Stanford University
Stanford, United States, 94305
Fred Hutchinson Cancer Research Center
Seattle, United States, 98109
University of Alabama at Birmingham
Birmingham, United States, 35294
Site IT39009
Genova, Italy, 16132
H. Lee Moffitt Cancer Center
Tampa, United States, 33612
Wake Forest Baptist Health
Winston-Salem, United States, 27157
Cleveland Clinic
Cleveland, United States, 44195
Site JP81004
Chuo-ku, Japan
University of California San Francisco
San Francisco, United States, 94143
Site FR33004
Lyon, France
Washington University in St. Louis
St. Louis, United States, 63110
Site BE32004
Gent, Belgium
Site GB44001
Sutton, United Kingdom
Northside
Atlanta, United States, 30342
Baylor College of Medicine
Houston, United States, 77030
Site JP81005
Osaka, Japan
University of Miami
Miami, United States, 33136
Site IT39005
Bergamo, Italy
University of Kansas Medical Center
Kansas City, United States, 66160-7233
Site JP81003
Fukuoka, Japan
University of Maryland Medical Systems
Baltimore, United States, 21201
Site TW88603
Taichung, Taiwan, Province of China
Mayo Clinic
Phoenix, United States, 85054
Site FR33005
Paris, France
Site DK45002
Arhus, Denmark
Emory University
Atlanta, United States, 30322
Site JP81006
Suita, Japan
Site FR33012
Besancon, France
Duke University Medical Center
Durham, United States, 27710
University of Michigan
Ann Arbor, United States, 48109
Site NZ64001
Grafton, New Zealand, 1010
Site CA15002
Winnipeg, Canada
Weill Cornell Medical Center
New York, United States, 10065
Site GB44010
Birmingham, United Kingdom
West Virginia University Hospital
Morgantown, United States, 26506-9214
Dana Farber Cancer Institute
Boston, United States, 02215
Northwestern Memorial Hospital
Chicago, United States, 60611
Site BE32003
Bruxelles, Belgium
Site JP81012
Nishinomiya, Japan
Medical University of South Carolina
Charleston, United States, 29425
Site JP81019
Kagoshima, Japan
Virginia Commonwealth University
Richmond, United States, 23298
Site ES34006
Salamanca, Spain
Site GB44005
Nottingham, United Kingdom
Site JP81007
Yokohama, Japan
Site JP81010
Sendai, Japan
Site AU61004
Westmead, Australia
Site NZ64002
Christchurch, New Zealand
Memorial Sloan Kettering
New York, United States, 10065
Site DE49006
Köln, Germany
Intermountain BMT
Salt Lake City, United States, 84143
Site NZ64003
Dunedin, New Zealand, 9001
Rush University Medical Center
Chicago, United States, 60612
Site GR30004
ATHENS, Greece
Site KR82005
Seoul, Republic of Korea
Site IT39006
Bologna, Italy
Site NZ64004
Wellington, New Zealand
Site FR33003
Paris, France
University of Massachusetts
Worcester, United States, 01655
Site CA15004
Hamilton, Canada
University of Minnesota School of Medicine
Minneapolis, United States, 55455
Site IT39014
Roma, Italy, 161
Penn State Hershey Medical Center
Hershey, United States, 17033
Site ES34003
Barcelona, Spain
Site IT39001
Torino, Italy
Site IT39003
Roma, Italy