Study summary

The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.

Additional Study Details

Phase
Phase 3
Product
  • gilteritinib
  • Placebo
  • Type
    Interventional
    Masking
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Enrollment number
    356
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English
    Protocol
    Available Language(s): English
    Statistical Analysis Plan (SAP)
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants 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)? Contact us by filling out your information to the right and we’ll respond to you.

    • A patient
    • A caregiver
    • A parent
    • A healthcare provider
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

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

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