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

NCT ID: NCT06578247

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-19

Study Completion Date

2030-06-26

Brief Summary

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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).

Detailed Description

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This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.

Conditions

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Leukemia

Keywords

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acute myeloid leukemia quizartinib FLT3 FLT3-ITD Chemotherapy FLT3-WT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
This study has a double-blind design. Neither the participants nor any of the investigators, Sponsor, Independent Review Committee (IRC) or contract research organizations (CROs) will be aware of the treatments received. An independent biostatistician, not otherwise part of the Sponsor trial team, will generate the randomization schedule.

Study Groups

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Arm A: Quizartinib + Chemotherapy

Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive quizartinib at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)

Group Type EXPERIMENTAL

Quizartinib

Intervention Type DRUG

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

Chemotherapy

Intervention Type DRUG

Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).

Arm B: Placebo + Chemotherapy

Participants will receive placebo at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Chemotherapy

Intervention Type DRUG

Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).

Arm C: Quizartinib + Chemotherapy then Placebo Maintenance

Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)

Group Type EXPERIMENTAL

Quizartinib

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Chemotherapy

Intervention Type DRUG

Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).

Interventions

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Quizartinib

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Chemotherapy

Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).

Intervention Type DRUG

Other Intervention Names

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Test Product Placebo Control Cytarabine, Daunorubicin or Idarubicin Standard Chemotherapy

Eligibility Criteria

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Inclusion Criteria

1. Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved ICF before performance of any trial-specific procedures or tests.
2. ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening).
3. Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
4. Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
5. Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment

Exclusion Criteria

1. Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy.
3. Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others.
4. Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD \[+\]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
5. Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy:

1. Leukapheresis;
2. Treatment for hyperleukocytosis with hydroxyurea;
3. Cranial radiotherapy for central nervous system (CNS) leukostasis;
4. Prophylactic intrathecal chemotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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City of Hope Phoenix

Goodyear, Arizona, United States

Site Status NOT_YET_RECRUITING

Mayo Clinic - Phoenix

Phoenix, Arizona, United States

Site Status NOT_YET_RECRUITING

University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status RECRUITING

Ucsf - School of Medicine

San Francisco, California, United States

Site Status RECRUITING

Stanford University School of Medicine- Parent

Stanford, California, United States

Site Status RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

Mayo Clinic Hospital

Jacksonville, Florida, United States

Site Status NOT_YET_RECRUITING

Florida Hospital Cancer Institute - Kissimmee

Kissimmee, Florida, United States

Site Status RECRUITING

Tampa General Hospital

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Augusta University

Augusta, Georgia, United States

Site Status NOT_YET_RECRUITING

Robert H Lurie Comprehensive Cancer Center Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, United States

Site Status RECRUITING

The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

University of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

Ochsner Medical Center - New Orleans

New Orleans, Louisiana, United States

Site Status NOT_YET_RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

University of Michigan Comprehensive Cancer Center Michigan Medicine

Ann Arbor, Michigan, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

University of Minnesota Medical School - Twin Cities Campus

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status NOT_YET_RECRUITING

Washington University

St Louis, Missouri, United States

Site Status NOT_YET_RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Thomas Jefferson Univ Hosp

Haddonfield, New Jersey, United States

Site Status RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center - Main

New York, New York, United States

Site Status NOT_YET_RECRUITING

Upstate University Hospital

Syracuse, New York, United States

Site Status NOT_YET_RECRUITING

University of North Carolina Hospitals

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Duke Cancer Institute - Sarcoma Research

Durham, North Carolina, United States

Site Status RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

Site Status NOT_YET_RECRUITING

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status RECRUITING

The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

Site Status RECRUITING

Ohio Health Marion Area Physicians

Columbus, Ohio, United States

Site Status RECRUITING

Peggy & Charles Stephenson Oklaho

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Oregon Health & Science University (Ohsu)

Portland, Oregon, United States

Site Status NOT_YET_RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Upmc Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Tristar Bone Marrow Transplant

Nashville, Tennessee, United States

Site Status RECRUITING

South Austin Medical Center

Austin, Texas, United States

Site Status NOT_YET_RECRUITING

Houston Methodist Hospital

Houston, Texas, United States

Site Status RECRUITING

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Uva Health System

Charlottesville, Virginia, United States

Site Status NOT_YET_RECRUITING

Virginia Commonwealth University (Vcu) Massey Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Royal Adelaide Hospital

Adelaide, , Australia

Site Status NOT_YET_RECRUITING

Flinders Medical Centre (Fmc)

Bedford Park, , Australia

Site Status NOT_YET_RECRUITING

Box Hill Hospital

Box Hill, , Australia

Site Status NOT_YET_RECRUITING

Concord Repatriation General Hospital

Concord, , Australia

Site Status NOT_YET_RECRUITING

St Vincent'S Hospital Melbourne

Darlinghurst, , Australia

Site Status NOT_YET_RECRUITING

Townsville University Hospital

Douglas, , Australia

Site Status NOT_YET_RECRUITING

Liverpool Hospital

Liverpool, , Australia

Site Status NOT_YET_RECRUITING

The Alfred Hospital

Melbourne, , Australia

Site Status RECRUITING

Fiona Stanley Hospital

Murdoch, , Australia

Site Status RECRUITING

Sir Charles Gairdner Hospital

Perth, , Australia

Site Status RECRUITING

Princess Alexandra Hospital

Woolloongabba, , Australia

Site Status NOT_YET_RECRUITING

Ordensklinikum Linz Gmbh - Elisabethinen

Linz, , Austria

Site Status RECRUITING

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, , Austria

Site Status RECRUITING

Hanusch Krankenhaus Der Wgkk Wien

Vienna, , Austria

Site Status NOT_YET_RECRUITING

Institut Jules Bordet

Anderlecht, , Belgium

Site Status RECRUITING

ZNA

Antwerp, , Belgium

Site Status RECRUITING

Az Sint-Jan

Bruges, , Belgium

Site Status RECRUITING

Uz Leuven

Leuven, , Belgium

Site Status RECRUITING

Chu of Liège

Liège, , Belgium

Site Status RECRUITING

AZ DELTA

Roeselare, , Belgium

Site Status RECRUITING

Cetus Hospital Dia Oncologia

Belo Horizonte, , Brazil

Site Status RECRUITING

Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu

Botucatu, , Brazil

Site Status RECRUITING

Centro de Hematologia E Hemoterapia - Hemocentro de Campinas - Unicamp

Campinas, , Brazil

Site Status NOT_YET_RECRUITING

Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

Campinas, , Brazil

Site Status RECRUITING

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Curitiba, , Brazil

Site Status RECRUITING

Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Că'Ncer

Curitiba, , Brazil

Site Status NOT_YET_RECRUITING

Cepon - Centro De Pesquisas Oncolagicas de Santa Catarina

Florianópolis, , Brazil

Site Status RECRUITING

HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

Fortaleza, , Brazil

Site Status RECRUITING

HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

Goiânia, , Brazil

Site Status RECRUITING

Hc-Ufg - Hospital Das Clă Nicas Da Universidade Federal de Goiă S

Goiânia, , Brazil

Site Status NOT_YET_RECRUITING

Fundacao Doutor Amaral Carvalho

Jaú, , Brazil

Site Status RECRUITING

Fundaã§Ã£O Doutor Amaral Carvalho

Jaú, , Brazil

Site Status NOT_YET_RECRUITING

Hospital de Clínicas de Passo Fundo

Passo Fundo, , Brazil

Site Status RECRUITING

Hospital de Clă Nicas de Passo Fundo

Passo Fundo, , Brazil

Site Status NOT_YET_RECRUITING

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, , Brazil

Site Status RECRUITING

Hospital de Clă Nicas de Porto Alegre

Porto Alegre, , Brazil

Site Status RECRUITING

Hospital Ernesto Dornelles

Porto Alegre, , Brazil

Site Status NOT_YET_RECRUITING

INCA - Instituto Nacional de Cancer

Rio de Janeiro, , Brazil

Site Status RECRUITING

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

Sao Jose Rio Preto, , Brazil

Site Status RECRUITING

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

São Paulo, , Brazil

Site Status RECRUITING

Hospital Beneficencia Portuguesa da Sao Paulo

São Paulo, , Brazil

Site Status RECRUITING

Hospital Nove de Julho

São Paulo, , Brazil

Site Status RECRUITING

Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul

São Paulo, , Brazil

Site Status RECRUITING

Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira

SĂŁo Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Umhat 'Dr. Georgi Stranski', Ead

Pleven, , Bulgaria

Site Status RECRUITING

Umhat 'Sv. Georgi', Ead

Plovdiv, , Bulgaria

Site Status NOT_YET_RECRUITING

Umhat  Sv. Ivan Rilskiâ , Ead

Sofia, , Bulgaria

Site Status RECRUITING

Military Medical Academy - Mhat - Sofia

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

'Shathd' Ead Sofia

Sofia, , Bulgaria

Site Status RECRUITING

Umhat Prof. Dr. Stoyan Kirkovich Ad

Stara Zagora, , Bulgaria

Site Status RECRUITING

London Health Sciences Centre

London, , Canada

Site Status RECRUITING

McGill University - Dept. Oncology Clinical Research Program

Montreal, , Canada

Site Status RECRUITING

The Ottawa Hospital - General Campus

Ottawa, , Canada

Site Status RECRUITING

Saskatoon Cancer Centre

Saskatoon, , Canada

Site Status NOT_YET_RECRUITING

Princess Margaret Cancer Center

Toronto, , Canada

Site Status RECRUITING

Peking University First Hospital

Beijing, , China

Site Status RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

The First Hospital of Jilin University

Changchun, , China

Site Status RECRUITING

Xiangya Hospital, Central South University

Changsha, , China

Site Status RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, , China

Site Status RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status RECRUITING

Sun Yat-Sen University, Cancer Center

Guangzhou, , China

Site Status RECRUITING

Guangdong Provincial People'S Hospital

Guangzhou, , China

Site Status NOT_YET_RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, , China

Site Status RECRUITING

Qilu Hospital of Shandong University

Jinan, , China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status RECRUITING

Zhong Da Hospital, Southeast University

Nanjing, , China

Site Status NOT_YET_RECRUITING

Affiliated Hospital of Nantong University

Nantong, , China

Site Status NOT_YET_RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, , China

Site Status RECRUITING

Shanghai Tongren Hospital

Shanghai, , China

Site Status RECRUITING

Shengjing Hospital of China Medical University

Shengyang, , China

Site Status NOT_YET_RECRUITING

Shenzhen Second People'S Hospital

Shenzhen, , China

Site Status NOT_YET_RECRUITING

The Second Hospital of Hebei Medic

Shijiazhuang, , China

Site Status RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, , China

Site Status RECRUITING

Institute of Hematology and Hospital of Blood Disease

Tianjin, , China

Site Status RECRUITING

Tianjin Medical University General Hospital

Tianjin, , China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

Site Status RECRUITING

Wuxi People'S Hospital

Wuxi, , China

Site Status RECRUITING

The First Affiliated Hospital of Xiâ An Jiaotong University

Xi'an, , China

Site Status RECRUITING

Yantai Yuhuangding Hospital

Yantai, , China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, , China

Site Status RECRUITING

Clinical Hospital Centre Rijeka

Rijeka, , Croatia

Site Status RECRUITING

Clinical Hospital Centar Zagreb

Zagreb, , Croatia

Site Status RECRUITING

Clinical Hospital Dubrava

Zagreb, , Croatia

Site Status RECRUITING

Fakultni Nemocnice Brno

Brno, , Czechia

Site Status RECRUITING

Fakultni Nemocnice Hradec Kralove

Hradec Králové, , Czechia

Site Status NOT_YET_RECRUITING

Fakultni Nemocnice Plzen

Pilsen, , Czechia

Site Status RECRUITING

Fakultni Nemocnice Ostrava

Poruba, , Czechia

Site Status RECRUITING

Fakultni Nemocnice Kralovske Vinohrady

Prague, , Czechia

Site Status RECRUITING

Ustav Hematologie A Krevni Transf

Prague, , Czechia

Site Status NOT_YET_RECRUITING

Chu Angers - Hă"Pital Hă"Tel Dieu

Angers, , France

Site Status NOT_YET_RECRUITING

Chu de Caen

Caen, , France

Site Status RECRUITING

Chu de Grenoble - Hospital Albert Michallon

La Tronche, , France

Site Status RECRUITING

Centre Hospitalier de Versailles

Le Chesnay, , France

Site Status RECRUITING

Hopital Claude Huriez - Chru Lille

Lille, , France

Site Status RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

Hopital de La Conception - Aphm

Marseille, , France

Site Status NOT_YET_RECRUITING

Chu de Nantes - Hotel Dieu

Nantes, , France

Site Status RECRUITING

CHU Nice - Hôpital de l'Archet 1

Nice, , France

Site Status RECRUITING

Hospital Saint-Louis

Paris, , France

Site Status RECRUITING

Chu de Bordeaux - Hă"Pital Haut-Lă Vă Que

Pessac, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Lyon Sud

Pierre BĂŠnite, , France

Site Status RECRUITING

Chu Rennes - Hopital Pontchaillou

Rennes, , France

Site Status RECRUITING

Chu Amiens - Hopital Sud

Salouël, , France

Site Status RECRUITING

Institut de Cancă Rologie de Strasbourg Europe - Icans

Strasbourg, , France

Site Status NOT_YET_RECRUITING

Institut Universitaire Du Cancer de Toulouse- Iuct-O

Toulouse, , France

Site Status RECRUITING

Klinikum Aschaffenburg-Alzenau

Alzenau in Unterfranken, , Germany

Site Status NOT_YET_RECRUITING

Staedtisches Klinikum Braunschweig Ggmbh

Braunschweig, , Germany

Site Status NOT_YET_RECRUITING

Universitaetsklinikum Carl Gustav Carus Tu Dresden

Dresden, , Germany

Site Status NOT_YET_RECRUITING

Universitaetsklinikum Essen

Essen, , Germany

Site Status NOT_YET_RECRUITING

Krh Klinikum Siloah

Hanover, , Germany

Site Status NOT_YET_RECRUITING

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status NOT_YET_RECRUITING

Universitaetsklinikum Schleswig-Holstein

Kiel, , Germany

Site Status NOT_YET_RECRUITING

Universită"Tsklinikum Leipzig Klinik Fă R Hă"Matologie Internistische Onkologie Hă"Mostaseol

Leipzig, , Germany

Site Status NOT_YET_RECRUITING

Universitaetsklinikum Muenster

Münster, , Germany

Site Status NOT_YET_RECRUITING

The University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

The Chinese University of Hong Kong (Cuhk)

Shatin, , Hong Kong

Site Status RECRUITING

Semmelweis Egyetem

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

Debreceni Egyetem

Debrecen, , Hungary

Site Status NOT_YET_RECRUITING

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

Győr, , Hungary

Site Status NOT_YET_RECRUITING

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , Hungary

Site Status NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari

Bari, , Italy

Site Status NOT_YET_RECRUITING

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)

Brescia, , Italy

Site Status RECRUITING

Irccs Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori 'Dino Amadori' - Irst

Meldola, , Italy

Site Status RECRUITING

Ospedale San Raffaele

Milan, , Italy

Site Status NOT_YET_RECRUITING

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

Milan, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Maggiore Di Novara

Novara, , Italy

Site Status RECRUITING

Azienda Ospedaliera Vincenzo Cervello

Palermo, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Roma, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, , Italy

Site Status NOT_YET_RECRUITING

Istituto Clinico Humanitas

Rozzano, , Italy

Site Status NOT_YET_RECRUITING

Irccs Ospedale Casa Sollievo Della Sofferenza

San Giovanni Rotondo, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Cittă Della Salute E Della Scienza Di Torino

Torino, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Mauriziano Umberto I

Torino, , Italy

Site Status NOT_YET_RECRUITING

Asst Dei Sette Laghi Ospedale Di Circolo E Fondazione Macchi Varese

Varese, , Italy

Site Status NOT_YET_RECRUITING

Akita University Hospital

Akita, , Japan

Site Status RECRUITING

Aomori Prefetural Central Hospital

Aomori, , Japan

Site Status RECRUITING

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō City, , Japan

Site Status NOT_YET_RECRUITING

Chiba Aoba Municipal Hospital

Chiba, , Japan

Site Status RECRUITING

Kyushu University Hospital

Fukuoka, , Japan

Site Status RECRUITING

Chugoku Central Hospital

Fukuyama, , Japan

Site Status RECRUITING

Gifu Municipal Hospital

Gifu, , Japan

Site Status RECRUITING

Hamamatsu University School of Medicine, University Hospital

Hamamatsu, , Japan

Site Status RECRUITING

Tesshokai Kameda General Hospital

Kamogawa-shi, , Japan

Site Status RECRUITING

Kanazawa University Hospital

Kanazawa, , Japan

Site Status RECRUITING

National Hospital Organization Kumamoto Medical Center

Kumamoto, , Japan

Site Status RECRUITING

Saiseikai Maebashi Hospital

Maebashi, , Japan

Site Status RECRUITING

Ehime Prefectural Central Hospital

Matsuyama, , Japan

Site Status RECRUITING

Nagoya University Hospital

Nagoya, , Japan

Site Status RECRUITING

Japan RED CROSS OSAKA HOSPITAL

Osakar, , Japan

Site Status RECRUITING

Hokkaido University Hospital

Sapporo, , Japan

Site Status RECRUITING

Sapporo Hokuyu Hospital

Sapporo, , Japan

Site Status RECRUITING

Tenri Hospital

Tenri, , Japan

Site Status RECRUITING

Haukeland Universitetssykehus

Bergen, , Norway

Site Status RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

University Hospital of North Norway

Tromsø, , Norway

Site Status NOT_YET_RECRUITING

Klinika Hematoonkologii I Transplantacji Szpiku

Lublin, , Poland

Site Status NOT_YET_RECRUITING

Spzoz Msw Zwarmiĺ Sko-Mazurskimcen.Onko.Wolsztynie

Olsztyn, , Poland

Site Status RECRUITING

Wojewodzki Szpital Zespolony Im. L. Rydygiera W Toruniu

Torun, , Poland

Site Status RECRUITING

Instytut Hematologii I Transfuzjologii

Warsaw, , Poland

Site Status NOT_YET_RECRUITING

Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

Instituto Portugues De Oncologia do Porto Francisco Gentil, EPE

Porto, , Portugal

Site Status RECRUITING

Spitalul Clinic Colentina

Bucharest, , Romania

Site Status RECRUITING

Institutul Clinic Fundeni

Bucharest, , Romania

Site Status RECRUITING

Spitalul Clinic Coltea

Bucharest, , Romania

Site Status RECRUITING

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Cluj-Napoca, , Romania

Site Status RECRUITING

Spitalul Clinic Municipal Filantropia Craiova

Craiova, , Romania

Site Status RECRUITING

Military Medical Academy

Belgrade, , Serbia

Site Status NOT_YET_RECRUITING

University Clinical Center of Serbia

Belgrade, , Serbia

Site Status NOT_YET_RECRUITING

University Clinical Center Nis

Niš, , Serbia

Site Status NOT_YET_RECRUITING

National University Hospital

Singapore, , Singapore

Site Status NOT_YET_RECRUITING

Curie Oncology Pte Ltd

Singapore, , Singapore

Site Status RECRUITING

Inje University Haeundae Paik Hospital

Busan, , South Korea

Site Status RECRUITING

Pusan National University Hospital

Busan, , South Korea

Site Status RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status RECRUITING

Yeungnam University Hospital

Daegu, , South Korea

Site Status NOT_YET_RECRUITING

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status RECRUITING

Chonnam National University Hwasun Hospital

Hwasun-gun, , South Korea

Site Status RECRUITING

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status RECRUITING

Jeonbuk National University Hospital

Jeonju, , South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

The Catholic University of Korea, Seoul St. Mary'S Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Ajou University Hospital

Suwon, , South Korea

Site Status RECRUITING

Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Complejo Hospitalario Universitario de Albacete

Albacete, , Spain

Site Status NOT_YET_RECRUITING

Ico Badalona - Hospital Universitari

Badalona, , Spain

Site Status RECRUITING

Hospital de La Santa Creu I Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitari Vall D'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario De Burgos

Burgos, , Spain

Site Status RECRUITING

Hospital San Pedro de Alcantara

Cáceres, , Spain

Site Status RECRUITING

Hospital Universitario Reina Sofia

Córdoba, , Spain

Site Status RECRUITING

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas, , Spain

Site Status RECRUITING

Clinica Universidad de Navarra

Madrid, , Spain

Site Status RECRUITING

Md Anderson Cancer Centre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, , Spain

Site Status RECRUITING

Hospital Regional Universitario de Malaga

Málaga, , Spain

Site Status RECRUITING

Hospital General Universitario Morales Meseguer

Murcia, , Spain

Site Status RECRUITING

Hospital Universitari Son Espases

Palma de Mallorca, , Spain

Site Status RECRUITING

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, , Spain

Site Status RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status RECRUITING

Hospital Universitario Dr. Peset

Valencia, , Spain

Site Status RECRUITING

Hospital Universitari I Politecnic La Fe

Valencia, , Spain

Site Status RECRUITING

Sahlgrenska Universitetssjukhuset

Gasteborg, , Sweden

Site Status RECRUITING

Skă Nes Universitetssjukhus, Lund

Lund, , Sweden

Site Status RECRUITING

Akademiska Sjukhuset

Uppsala, , Sweden

Site Status NOT_YET_RECRUITING

Inselspital - Universitaetsspital Bern

Bern, , Switzerland

Site Status NOT_YET_RECRUITING

Luzerner Kantonsspital - Luzern

Lazern 16, , Switzerland

Site Status RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status NOT_YET_RECRUITING

China Medical University Hospital

Taichung, , Taiwan

Site Status NOT_YET_RECRUITING

National Cheng Kung University Hospitalx

Tainan, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status RECRUITING

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status RECRUITING

King'S College Hospital

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Hammersmith Hospital

London, , United Kingdom

Site Status RECRUITING

Maidstone Hospital

Maidstone, , United Kingdom

Site Status NOT_YET_RECRUITING

Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status RECRUITING

Churchill Hospital

Oxford, , United Kingdom

Site Status RECRUITING

Torbay Hospital

Torquay, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Austria Belgium Brazil Bulgaria Canada China Croatia Czechia France Germany Hong Kong Hungary Italy Japan Norway Poland Portugal Romania Serbia Singapore South Korea Spain Sweden Switzerland Taiwan United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Daiichi Sankyo Contact for Clinical Trial Information

Role: CONTACT

Phone: 908-992-6400

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-507936-20-00

Identifier Type: CTIS

Identifier Source: secondary_id

AC220-168

Identifier Type: -

Identifier Source: org_study_id