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Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
Sponsor: Daiichi Sankyo
Summary
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2024-11-19
Completion Date
2030-06-26
Last Updated
2026-07-02
Healthy Volunteers
No
Conditions
Interventions
Quizartinib
Participants will receive quizartinib at 60 mg/day orally once daily
Placebo
Participants will receive placebo at 60 mg/day orally once daily
Chemotherapy
Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).
Locations (284)
City of Hope Phoenix
Goodyear, Arizona, United States
Mayo Clinic - Phoenix
Phoenix, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
David Geffen School of Medicine
Los Angeles, California, United States
University of California Davis Health System
Sacramento, California, United States
Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Stanford University School of Medicine- Parent
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic Hospital
Jacksonville, Florida, United States
Florida Hospital Cancer Institute - Kissimmee
Kissimmee, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Robert H Lurie Comprehensive Cancer Center Northwestern University
Chicago, Illinois, United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Medical Center - New Orleans
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, United States
University of Minnesota Medical School - Twin Cities Campus
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Thomas Jefferson Univ Hosp
Haddonfield, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center - Main
Long Island City, New York, United States
Memorial Sloan Kettering Cancer Center - Main
New York, New York, United States
Upstate University Hospital
Syracuse, New York, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Duke Cancer Institute - Sarcoma Research
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Peggy & Charles Stephenson Oklahoma Cancer Ctr
Oklahoma City, Oklahoma, United States
Oregon Health & Science University (Ohsu)
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Tristar Bone Marrow Transplant
Nashville, Tennessee, United States
South Austin Medical Center
Austin, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Uva Health System
Charlottesville, Virginia, United States
Virginia Commonwealth University (Vcu) Massey Cancer Center
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Adelaide Hospital
Adelaide, Australia
Flinders Medical Centre (Fmc)
Bedford Park, Australia
Flinders Medical Centre (Fmc)
Bedford Park, Australia
Box Hill Hospital
Box Hill, Australia
Concord Repatriation General Hospital
Concord, Australia
St Vincent'S Hospital Melbourne
Darlinghurst, Australia
Townsville University Hospital
Douglas, Australia
Liverpool Hospital
Liverpool, Australia
The Alfred Hospital
Melbourne, Australia
Fiona Stanley Hospital
Murdoch, Australia
Sir Charles Gairdner Hospital
Perth, Australia
Princess Alexandra Hospital
Woolloongabba, Australia
Ordensklinikum Linz Gmbh - Elisabethinen
Linz, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria
Hanusch Krankenhaus Der Wgkk Wien
Vienna, Austria
Institut Jules Bordet
Anderlecht, Belgium
ZNA
Antwerp, Belgium
Az Sint-Jan
Bruges, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Uz Leuven
Leuven, Belgium
Chu de Liage
Liège, Belgium
AZ DELTA
Roeselare, Belgium
Cetus Hospital Dia Oncologia
Belo Horizonte, Brazil
Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu
Botucatu, Brazil
Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP
Campinas, Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, Brazil
Cepon - Centro De Pesquisas Oncolagicas de Santa Catarina
Florianópolis, Brazil
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Brazil
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, Brazil
Hospital de Clínicas de Passo Fundo
Passo Fundo, Brazil
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Hospital de Clănicas de Porto Alegre
Porto Alegre, Brazil
INCA - Instituto Nacional de Cancer
Rio de Janeiro, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose Rio Preto, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, Brazil
Hospital Beneficencia Portuguesa da Sao Paulo
São Paulo, Brazil
Hospital Nove de Julho
São Paulo, Brazil
Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul
São Paulo, Brazil
Umhat 'Dr. Georgi Stranski', Ead
Pleven, Bulgaria
Umhat 'Sv. Georgi', Ead
Plovdiv, Bulgaria
Umhat Âsv. Ivan Rilskiâ, Ead
Sofia, Bulgaria
Military Medical Academy - Mhat - Sofia
Sofia, Bulgaria
'Shathd' Ead Sofia
Sofia, Bulgaria
Umhat Prof. Dr. Stoyan Kirkovich Ad
Stara Zagora, Bulgaria
London Health Sciences Centre
London, Canada
McGill University - Dept. Oncology Clinical Research Program
Montreal, Canada
The Ottawa Hospital - General Campus
Ottawa, Canada