Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)

NCT ID: NCT02668653

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 539 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2023-06-16

Brief Summary

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.

Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML).

Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

Detailed Description

This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of this study is to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as continuation therapy for up to 36 cycles) on overall survival in subjects with FLT3-internal tandem duplication (ITD) positive AML.

Conditions

Acute Myeloid Leukemia; Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Chemotherapy plus quizartinib

Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by the experimental drug quizartinib

Consolidation: up to 4 cycles of cytarabine followed by the experimental drug quizartinib and/or hematopoeitic stem cell transplant

Continuation: up to 36 cycles with the experimental drug quizartinib

Group Type: EXPERIMENTAL

Chemotherapy

Intervention Type: DRUG

Quizartinib

Intervention Type: DRUG

Chemotherapy plus placebo

Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by placebo

Consolidation: up to 4 cycles of cytarabine followed by placebo and/or hematopoeitic stem cell transplant

Continuation: up to 36 cycles with placebo

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Chemotherapy

Intervention Type: DRUG

Quizartinib

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Cytarabine; Daunorubicin; Idarubicin; Test Product; Placebo Control

Eligibility Criteria

Inclusion Criteria

1. Must be competent and able to comprehend, sign, and date an Ethics Committee (EC) or Institutional Review Board approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests;

2. Is ≥18 years or the minimum legal adult age (whichever is greater) and ≤75 years (at Screening);

3. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm, based on the World Health Organization (WHO) 2008 classification (at Screening);

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (at the time the participant signs their first ICF);

5. Presence of FLT3-ITD activating mutation in bone marrow (allelic ratio of ≥3% FLT3-ITD/total FLT3);

6. Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol;

7. Adequate renal function defined as:

a. Creatinine clearance >50 mL/min, as calculated with the modified Cockcroft Gault equation

8. Adequate hepatic function defined as:

1. Total serum bilirubin (TBL) ≤1.5 × upper limit of normal (ULN) unless the participant has documented Gilbert's syndrome or the increase is related to increased unconjugated (indirect) bilirubin due to hemolysis;

2. Serum alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × ULN;

9. Serum electrolytes within normal limits: potassium, calcium (total, or corrected for serum albumin in case of hypoalbuminemia or ionized calcium) and magnesium. If outside of normal limits, participant will be eligible when electrolytes are corrected;

10. If a woman of childbearing potential, must have a negative serum pregnancy test upon entry into this study and must be willing to use highly effective birth control upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months);

11. If male, must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later.

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 breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (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 for other neoplasms;

3. Prior treatment for AML, except for the following allowances:

• Leukapheresis;
• Treatment for hyperleukocytosis with hydroxyurea;
• Cranial radiotherapy for central nervous system (CNS) leukostasis;
• Prophylactic intrathecal chemotherapy;
• Growth factor/cytokine support;

4. Prior treatment with quizartinib or other FLT3-ITD inhibitors;

5. Prior treatment with any investigational drug or device within 30 days prior to Randomization (within 2 weeks for investigational or approved immunotherapy) or currently participating in other investigational procedures;

6. History of known CNS leukemia, including cerebrospinal fluid positive for AML blasts; lumbar puncture is recommended for participants with symptoms of CNS leukemia to rule out extramedullary CNS involvement;

7. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for at least 2 years;

8. Uncontrolled or significant cardiovascular disease, including any of the following:

• Bradycardia of less than 50 beats per minute, unless the participant has a pacemaker;
• Fridericia's Heart Rate Correction Formula (QTcF) interval >450 msec;
• Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
• Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
• History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
• History of second (Mobitz II) or third degree heart block (participants with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
• History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
• History of New York Heart Association Class 3 or 4 heart failure;
• Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;
• Complete left bundle branch block;

9. Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;

10. Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C);

11. Known history of human immunodeficiency virus (HIV). Participants should be tested for HIV prior to Randomization if required by local regulations or EC;

12. History of hypersensitivity to any excipients in the quizartinib/placebo tablets;

13. Females who are pregnant or breastfeeding;

14. Otherwise considered inappropriate for the study by the Investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

Ospedale S. Maria delle Croci - Ravenna

Ravenna, , Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, , Italy

Ospedale S. Eugenio

Roma, , Italy

Policlinico Tor Vergata

Roma, , Italy

IRCCS Ospedale San Raffaele

Roma, , Italy

Azienda Ospedaliero-Universitaria Careggi

Roma, , Italy

University of Florida (UF) Health Shands Hospital

Gainesville, Florida, United States

The University of Chicago Medical Center

Chicago, Illinois, United States

Franciscan St. Francis Health Indianapolis

Indianapolis, Indiana, United States

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

NY Medical College - Hudson Valley Hematology Oncology Associates

Valhalla, New York, United States

Duke Clinical Research Institute

Durham, North Carolina, United States

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

West Virginia University Hospitals, Inc.

Morgantown, West Virginia, United States

Sanatorio Britanico

Rosario, Santa Fe Province, Argentina

Sanatorio Allende

Córdoba, , Argentina

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Townsville Hospital (TTH)

Douglas, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

AZ Sint-Jan Brugge-Oostende AV

Bruges, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

UCL Mont-Godinne

Yvoir, , Belgium

Hospital Amaral Carvalho

Brasília, , Brazil

Hospital do CEPON

Brasília, , Brazil

Instituto do Cancer do Estado de São Paulo

Brasília, , Brazil

Santa Casa de Misericórdia de Porto Alegre

Brasília, , Brazil

Hospital da Cidade de Passo Fundo

Passo Fundo, , Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, , Brazil

University Multiprofile Hospital for Active Treatment "Dr. G. Stranski" EAD

Pleven, , Bulgaria

University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

Sofia, , Bulgaria

Tom Baker Cancer Centre

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Vancouver General Hospital (VGH)

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Peking University First Hospital

Beijing, , China

The General Hospital of People's Liberation Army (301 Hospital)

Beijing, , China

Fujian Medical University Union Hospital

Fuzhou, , China

Guangdong General Hospital

Guangzhou, , China

Lanzhou University Second Hospital

Lanzhou, , China

Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School

Shanghai, , China

West China Hospital, Sichuan University

Taiyuan, , China

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, , China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

Tang Du Hospital, Fourth Military Medical University

Xi'an, , China

Henan Cancer Hospital

Zhengzhou, , China

Klinička Bolnica Dubrava

Zagreb, , Croatia

Klinička Bolnica Merkur

Zagreb, , Croatia

Klinički Bolnički Centar Zagreb

Zagreb, , Croatia

Fakultní Nemocnice Hradec Králové

Hradec Králové, , Czechia

Fakultní Nemocnice Olomouc

Olomouc, , Czechia

Fakultní Nemocnice Ostrava

Ostrava, , Czechia

Fakultni Nemocnice Plzen

Pilsen, , Czechia

Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze (UHKT)

Prague, , Czechia

Hospital A. Michallon

Grenoble, , France

Centre Hospitalier de Versailles - Hôpital André Mignot

Le Chesnay, , France

Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

Lille, , France

Centre Léon Bérard

Lyon, , France

L'Institut Paoli - Calmettes

Marguerittes, , France

Hôpital de la Conception

Marseille, , France

CHRU Montpellier - Saint Eloi

Montpellier, , France

Hôpital Saint-Antoine

Paris, , France

Hôpital Saint-Louis

Paris, , France

Hôpital Haut-Lévêque

Pessac, , France

Centre Hospitalier Lyon-Sud

Pierre-Bénite, , France

Centre Henri Becquerel - Centre de Lutte Contre le Cancer

Rouen, , France

Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

Toulouse, , France

HELIOS Klinikum Bad Saarow

Bad Saarow, , Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Städtisches Klinikum Braunschweig gGmbH

Braunschweig, , Germany

Marien Hospital Düsseldorf GmbH

Düsseldorf, , Germany

Universitätsklinikum Essen

Essen, , Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, , Germany

Universitätsklinikum Halle (Saale)

Halle, , Germany

Evangelisches Krankenhaus Hamm gGmbH

Hamm, , Germany

Medizinische Hochschule Hannover (MHH)

Hannover, , Germany

Universitätsklinikum Münster

Heidelberg, , Germany

Universitätsklinikum Tübingen

Heidelberg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitätsklinikum Leipzig

Leipzig, , Germany

Stauferklinikum Schwäbisch Gmünd

Mutlangen, , Germany

HELIOS Klinikum Wuppertal

Wuppertal, , Germany

Prince of Wales Hospital

Shatin, , Hong Kong

Markusovszky Egyetemi Oktatókórház

Budapest, , Hungary

Szegedi Tudományegyetem

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Debreceni Egyetem Klinikai Központ

Debrecen, , Hungary

Pecsi Tudomanyegyetem Klinikai Központ

Pécs, , Hungary

Markusovszky Egyetemi Oktatókórház

Szombathely, , Hungary

Assaf Harofeh Medical Center

Be’er Ya‘aqov, Tsifrin, Israel

Bnai Zion Medical Center

Haifa, , Israel

Rambam Medical Center

Haifa, , Israel

Hadassah University Medical Center

Jerusalem, , Israel

Rabin Medical Center - Beilinson Hospital

Petah Tikva, , Israel

The Chaim Sheba Medical Center

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo

Alessandria, , Italy

Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno

Ascoli Piceno, , Italy

Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

Bologna, , Italy

IRCCS AOU San Martino - IST

Genova, , Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

A.O.R.N. "A. Cardarelli"

Napoli, , Italy

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

Novara, , Italy

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, , Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

Palermo, , Italy

Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara

Roma, , Italy

Azienda Ospedaliera Universitaria "Federico II"

Roma, , Italy

Istituto Clinico Humanitas

Rozzano, , Italy

Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona

Salerno, , Italy

Azienda Ospedaliera Universitaria Senese

Siena, , Italy

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette

Torino, , Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, , Italy

ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi Varese

Varese, , Italy

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, Japan

Ehime Prefectural Central Hospital

Matsuyama, Ehime, Japan

University of Fukui Hospital

Yoshida, Fukui, Japan

Kyushu University Hospital

Higashi, Fukuoka, Japan

Gunmaken Saiseikai Maebashi Hospital

Maebashi, Gunma, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Chugoku Central Hospital

Fukuyama, Hiroshima, Japan

Sapporo Hokuyu Hospital

Sapporo, Hokkaido, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

National Hospital Organization Sendai Medical Center

Sendai, Miagi, Japan

Tenri Hospital

Tenri, Nara, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital

Bunkyō-Ku, Tokyo, Japan

The Jikei University Hospital

Minato-Ku, Tokyo, Japan

Akita University Hospital

Akita, , Japan

Aomori Prefectural Central Hospital

Aomori, , Japan

Chiba Aoba Municipal Hospital

Chiba, , Japan

Kameda Medical Center - Kameda General Hospital

Chiba, , Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Gifu Municipal Hospital

Gifu, , Japan

National Hospital Organization Kagoshima Medical Center

Kagoshima, , Japan

Kobe City Medical Center General Hospital

Kobe, , Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, , Japan

Nagasaki University Hospital

Nagasaki, , Japan

Osaka City General Hospital

Osaka, , Japan

Osaka Red Cross Hospital

Osaka, , Japan

NTT Medical Center Tokyo

Tokyo, , Japan

Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka

Słupsk, , Poland

Instytut Hematologii i Transfuzjologi

Warsaw, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wrocławiu

Warsaw, , Poland

Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra

Coimbra, , Portugal

Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos

Lisbon, , Portugal

Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António

Porto, , Portugal

Instituto Português Oncologia do Porto Francisco Gentil, EPE

Porto, , Portugal

Centro Hospitalar de São João, EPE - Hospital de São João

Porto, , Portugal

Institutul Regional de Oncologie Iași

Bucharest, , Romania

Spitalul Clinic Colentina

Bucharest, , Romania

Spitalul Clinic Coltea

Bucharest, , Romania

Spitalul Universitar de Urgenta Bucuresti

Bucharest, , Romania

Institutul Clinic Fundeni

Bucharest, , Romania

Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca

Cluj-Napoca, , Romania

Spitalul Clinic Municipal Filantropia Craiova

Craiova, , Romania

Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4005)

Târgu Mureş, , Romania

Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4008)

Târgu Mureş, , Romania

Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, , Russia

Penza Regional Oncology Dispensary

Penza, , Russia

Republican Hospital n.a.V.A. Baranov

Petrozavodsk, , Russia

Ryazan Regional Clinical Hospital

Ryazan, , Russia

Russian Research Institute of Hematology and Blood Transfusion

Saint Petersburg, , Russia

Leningrad Regional Clinic and Hospital

Saint Petersburg, , Russia

Almazov Federal North-West Medical Research Centre

Saint Petersburg, , Russia

Saratov State Medical University named after V.I. Razumovsky

Saratov, , Russia

Tula Regional Clinical Hospital

Tula, , Russia

Klinički Centar Srbije

Belgrade, , Serbia

Klinički Centar Niš

Niš, , Serbia

Klinički Centar Vojvodine

Novi Sad, , Serbia

National University Hospital (S) Pte Ltd

Singapore, , Singapore

Singapore General Hospital

Singapore, , Singapore

Inje University Haeundae Paik Hospital

Busan, , South Korea

Pusan National University Hospital

Busan, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

Daegu Catholic University Medical Center

Daegu, , South Korea

Chonnam National University Hwasun Hospital

Hwasun, , South Korea

Gachon University Gil Hospital

Incheon, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

SoonChunHyang University Seoul Hospital

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

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

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Ajou University Hospital

Sŏwŏn, , South Korea

Ulsan University Hospital (UUH)

Ulsan, , South Korea

Hospital Universitari Son Espases

Palma, Mallorca, Spain

Complexo Hospitalario Universitario A Coruña

A Coruña, , Spain

Complejo Hospitalario Universitario de Albacete - Hospital General Universitario

Albacete, , Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Catalan Institute of Oncology (ICO)

Badalona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital Clinic i Provincial

Barcelona, , Spain

Hospital Duran i Reynals

Barcelona, , Spain

Hospital de Basurto

Bilbao, , Spain

Hospital San Pedro de Alcántara

Cáceres, , Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Hospital Universitari de Girona Doctor Josep Trueta

Girona, , Spain

Complejo Hospitalario Universitario Granada

Granada, , Spain

Hospital Dr. Negrín

Las Palmas de Gran Canaria, , Spain

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Quirón Madrid

Madrid, , Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, , Spain

Hospital Regional Universitario de Málaga - Hospital General

Málaga, , Spain

Hospital Universitario Central de Asturias

Oviedo, , Spain

Complejo Hospitalario de Navarra

Pamplona, , Spain

Fundación Jiménez Díaz

Pamplona, , Spain

Hospital Clínico Universitario "Lozano Blesa"

Pamplona, , Spain

Hospital General Universitario Morales Meseguer

Pamplona, , Spain

Hospital Universitario Miguel Servet

Pamplona, , Spain

Hospital Álvaro Cunqueiro

Pamplona, , Spain

Hosp Universitario Salamanca

Salamanca, , Spain

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario

Santiago de Compostela, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital Universitari Joan XXIII de Tarragona

Tarragona, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Hospital Universitario Dr. Peset

Valencia, , Spain

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Chang Gung Medical Foundation - Kaohsiung Branch

Kaohsiung City, Niaosong District, Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang Gung Medical Foundation - Linkou Branch

Taoyuan District, , Taiwan

Cherkasy Regional Oncology Dispensary

Cherkasy, , Ukraine

Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho

Poltava, , Ukraine

Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

Vinnytsia, , Ukraine

Zhitomir Regional Clinical Hospital

Zhytomyr, , Ukraine

Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital

Maidstone, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Bulgaria; Canada; China; Croatia; Czechia; France; Germany; Hong Kong; Hungary; Israel; Italy; Japan; Poland; Portugal; Romania; Russia; Serbia; Singapore; South Korea; Spain; Taiwan; Ukraine; United Kingdom

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-004856-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

173667

Identifier Type: REGISTRY

Identifier Source: secondary_id

AC220-A-U302

Identifier Type: -

Identifier Source: org_study_id