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)

PHASE3CompletedINTERVENTIONAL
Enrollment

356

Participants

Timeline

Start Date

August 16, 2017

Primary Completion Date

January 7, 2023

Study Completion Date

May 9, 2023

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

gilteritinib

oral

DRUG

Placebo

oral

Trial Locations (118)

1010

Site NZ64001, Grafton

10065

Memorial Sloan Kettering, New York

Weill Cornell Medical Center, New York

16132

Site IT39009, Genova

19104

University of Pennsylvania, Philadelphia

21201

University of Maryland Medical Systems, Baltimore

21231

Johns Hopkins Hospital, Baltimore

27157

Wake Forest Baptist Health, Winston-Salem

27599

University of North Carolina, Chapel Hill

27710

Duke University Medical Center, Durham

30322

Emory University, Atlanta

30342

Northside, Atlanta

30912

Augusta University, Augusta

32610

University of Florida, Gainesville

33136

University of Miami, Miami

33612

H. Lee Moffitt Cancer Center, Tampa

35294

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

43210

Ohio State University, The, Columbus

44106

University Hospitals of Cleveland Medical Center, Cleveland

44195

Cleveland Clinic, Cleveland

46237

Indiana Blood and Marrow Transplant, Indianapolis

48201

Karmanos Cancer Center, Detroit

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin Hospital and Clinics, Madison

55455

University of Minnesota School of Medicine, Minneapolis

55905

Mayo Clinic, Rochester

60153

Loyola University Medical Center, Maywood

60611

Northwestern Memorial Hospital, Chicago

60612

Rush University Medical Center, Chicago

63110

Washington University in St. Louis, St Louis

68198

University of Nebraska Medical Center, Omaha

77030

Baylor College of Medicine, Houston

84143

Huntsman Cancer Institute, Salt Lake City

Intermountain BMT, Salt Lake City

85054

Mayo Clinic, Phoenix

85258

Virginia G Piper Cancer Center, Scottsdale

94143

University of California San Francisco, San Francisco

94305

Stanford University, Stanford

97239

Oregon Health and Science University, Portland

98109

Fred Hutchinson Cancer Research Center, Seattle

06511

Yale University School of Medicine, New Haven

66160-7233

University of Kansas Medical Center, Kansas City

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Boston

01655

University of Massachusetts, Worcester

26506-9214

West Virginia University Hospital, Morgantown

Unknown

Site AU61001, Liverpool

Site AU61002, Melbourne

Site AU61004, Westmead

Site BE32003, Brussels

Site BE32004, Ghent

Site CA15004, Hamilton

Site CA15003, Montreal

Site DK45002, Aarhus

Site DK45001, Copenhagen

Site FR33007, Lille

Site FR33004, Lyon

Site FR33005, Paris

Site FR33008, Pessac

Site FR33010, Vandœuvre-lès-Nancy

Site DE49006, Cologne

Site DE49002, Düsseldorf

Site DE49003, Halle

Site DE49005, Hamburg

Site DE49007, Mainz

Site DE49004, Münster

Site GR30004, Athens

Site GR30003, Rio

Site GR30001, Thessaloniki

Site IT39005, Bergamo

Site IT39006, Bologna

Site IT39002, Milan

Site IT39007, Milan

Site IT39011, Pescara

Site IT39003, Roma

Site IT39004, Udine

Site JP81014, Anjo

Site JP81011, Nagoya

Site JP81018, Sapporo

Site JP81021, Kobe

Site JP81012, Nishinomiya

Site JP81002, Isehara

Site JP81007, Yokohama

Site JP81010, Sendai

Site JP81006, Suita

Site JP81008, Shimotsuke

Site JP81013, Bunkyo-ku

Site JP81004, Chuo-ku

Site JP81016, Minato-ku

Site JP81020, Shinjuku-ku

Site JP81001, Fukuoka

Site JP81003, Fukuoka

Site JP81015, Kyoto

Site JP81017, Okayama

Site JP81005, Osaka

Site NZ64002, Christchurch

Site PL48004, Warsaw

Site KR82001, Seoul

Site KR82002, Seoul

Site KR82003, Seoul

Site KR82004, Seoul

Site KR82005, Seoul

Site ES34005, Barcelona

Site ES34006, Salamanca

Site ES34007, Santander

Site ES34002, Valencia

Site TW88603, Taichung

Site TW88602, Taipei

Site TW88605, Taoyuan District

Site GB44010, Birmingham

Site GB44003, Bristol

Site GB44004, London

Site GB44002, Manchester

Site GB44001, Sutton

08036

Site ES34004, Barcelona

G12 0YN

Site GB44009, Glasgow

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT02997202 - 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) | Biotech Hunter | Biotech Hunter