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ACTIVE NOT RECRUITING
NCT06578247
PHASE3

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

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

DRUG

Quizartinib

Participants will receive quizartinib at 60 mg/day orally once daily

DRUG

Placebo

Participants will receive placebo at 60 mg/day orally once daily

DRUG

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

And 184 more locations on ClinicalTrials.gov