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

PHASE3CompletedINTERVENTIONAL
Enrollment

539

Participants

Timeline

Start Date

September 1, 2016

Primary Completion Date

August 13, 2021

Study Completion Date

June 16, 2023

Conditions
Acute Myeloid LeukemiaLeukemia
Interventions
DRUG

Chemotherapy

DRUG

Quizartinib

DRUG

Placebo

Trial Locations (244)

100

National Taiwan University Hospital, Taipei

133

Fondazione Policlinico Universitario Agostino Gemelli, Roma

Ospedale S. Eugenio, Roma

Policlinico Tor Vergata, Roma

704

National Cheng Kung University Hospital, Tainan City

1000

"University Multiprofile Hospital for Active Treatment Sveti Georgi EAD", Sofia

1051

Markusovszky Egyetemi Oktatókórház, Budapest

Szegedi Tudományegyetem, Budapest

1083

Semmelweis Egyetem, Budapest

2006

Complejo Hospitalario Universitario de Albacete - Hospital General Universitario, Albacete

2298

Calvary Mater Newcastle, Waratah

3010

Hospital General Universitario de Alicante, Alicante

3080

Seoul National University Hospital, Seoul

3722

Severance Hospital, Seoul

4032

Debreceni Egyetem Klinikai Központ, Debrecen

4102

Princess Alexandra Hospital, Woolloongabba

4103

Universitätsklinikum Leipzig, Leipzig

4401

SoonChunHyang University Seoul Hospital, Seoul

4814

Townsville Hospital (TTH), Douglas

5030

Konkuk University Medical Center, Seoul

5505

Asan Medical Center, Seoul

5530

UCL Mont-Godinne, Yvoir

5800

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

6120

Universitätsklinikum Halle (Saale), Halle

6150

Fiona Stanley Hospital, Murdoch

6351

Samsung Medical Center, Seoul

6591

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

7014

Hospital Universitari Son Espases, Palma

7624

Pecsi Tudomanyegyetem Klinikai Központ, Pécs

8000

AZ Sint-Jan Brugge-Oostende AV, Bruges

8003

Hospital del Mar, Barcelona

8035

Hospital Universitario Vall d'Hebron, Barcelona

8036

Hospital Clinic i Provincial, Barcelona

8308

Korea University Guro Hospital, Seoul

8907

Hospital Duran i Reynals, Barcelona

8916

Catalan Institute of Oncology (ICO), Badalona

9000

Universitair Ziekenhuis Gent, Ghent

9700

Markusovszky Egyetemi Oktatókórház, Szombathely

10000

Klinička Bolnica Dubrava, Zagreb

Klinička Bolnica Merkur, Zagreb

Klinički Bolnički Centar Zagreb, Zagreb

10002

Hospital San Pedro de Alcántara, Cáceres

Zhitomir Regional Clinical Hospital, Zhytomyr

10043

Azienda Ospedaliero - Universitaria San Luigi Gonzaga, Orbassano

10117

Charité - Universitätsmedizin Berlin, Berlin

10126

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

10128

Azienda Ospedaliera Ordine Mauriziano di Torino, Torino

10595

NY Medical College - Hudson Valley Hematology Oncology Associates, Valhalla

11000

Klinički Centar Srbije, Belgrade

11217

Taipei Veterans General Hospital, Taipei

13009

L'Institut Paoli - Calmettes, Marguerittes

13385

Hôpital de la Conception, Marseille

13620

Seoul National University Bundang Hospital, Seongnam-si

14004

Hospital Universitario Reina Sofía, Córdoba

15006

Complexo Hospitalario Universitario A Coruña, A Coruña

15121

Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo, Alessandria

15526

HELIOS Klinikum Bad Saarow, Bad Saarow

15706

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

16132

IRCCS AOU San Martino - IST, Genova

16499

Ajou University Hospital, Sŏwŏn

17007

Hospital Universitari de Girona Doctor Josep Trueta, Girona

18000

Klinički Centar Niš, Niš

18009

Cherkasy Regional Oncology Dispensary, Cherkasy

18014

Complejo Hospitalario Universitario Granada, Granada

19104

Hospital of the University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University Hospital, Philadelphia

20089

Istituto Clinico Humanitas, Rozzano

20125

Institutul Regional de Oncologie Iași, Bucharest

Spitalul Clinic Colentina, Bucharest

Spitalul Clinic Coltea, Bucharest

Spitalul Universitar de Urgenta Bucuresti, Bucharest

20132

IRCCS Ospedale San Raffaele, Roma

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

21018

Vinnitsa Regional Clinical Hospital im. N.I. Pirogov, Vinnytsia

21100

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

21101

Klinički Centar Vojvodine, Novi Sad

21565

Gachon University Gil Hospital, Incheon

22328

Institutul Clinic Fundeni, Bucharest

26506

West Virginia University Hospitals, Inc., Morgantown

27710

Duke Clinical Research Institute, Durham

28007

Hospital General Universitario Gregorio Marañón, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Clínico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28100

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara, Novara

28222

Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda

28223

Hospital Quirón Madrid, Madrid

29010

Hospital Regional Universitario de Málaga - Hospital General, Málaga

30001

West China Hospital, Sichuan University, Taiyuan

30625

Medizinische Hochschule Hannover (MHH), Hannover

31008

Complejo Hospitalario de Navarra, Pamplona

Fundación Jiménez Díaz, Pamplona

"Hospital Clínico Universitario Lozano Blesa", Pamplona

Hospital General Universitario Morales Meseguer, Pamplona

Hospital Universitario Miguel Servet, Pamplona

Hospital Álvaro Cunqueiro, Pamplona

31048

Bnai Zion Medical Center, Haifa

31059

Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan, Toulouse

31096

Rambam Medical Center, Haifa

33011

Hospital Universitario Central de Asturias, Oviedo

33305

Chang Gung Medical Foundation - Linkou Branch, Taoyuan District

33604

Hôpital Haut-Lévêque, Pessac

34295

CHRU Montpellier - Saint Eloi, Montpellier

35010

Hospital Dr. Negrín, Las Palmas de Gran Canaria

36011

Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho, Poltava

37007

Hosp Universitario Salamanca, Salamanca

38043

Hospital A. Michallon, Grenoble

38114

Städtisches Klinikum Braunschweig gGmbH, Braunschweig

39008

Hospital Universitario Marqués de Valdecilla, Santander

40138

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

40447

China Medical University Hospital, Taichung

40479

Marien Hospital Düsseldorf GmbH, Düsseldorf

40536

University of Kentucky Chandler Medical Center, Lexington

41013

Hospital Universitario Virgen del Rocío, Seville

41944

Kyungpook National University Hospital, Daegu

42283

HELIOS Klinikum Wuppertal, Wuppertal

42415

Yeungnam University Medical Center, Daegu

42472

Daegu Catholic University Medical Center, Daegu

43005

Hospital Universitari Joan XXIII de Tarragona, Tarragona

44033

Ulsan University Hospital (UUH), Ulsan

44106

University Hospitals Seidman Cancer Center, Cleveland

45122

Universitätsklinikum Essen, Essen

46010

Hospital Clinico Universitario de Valencia, Valencia

46017

Hospital Universitario Dr. Peset, Valencia

46237

Franciscan St. Francis Health Indianapolis, Indianapolis

48013

Hospital de Basurto, Bilbao

48108

Inje University Haeundae Paik Hospital, Busan

48121

Ospedale S. Maria delle Croci - Ravenna, Ravenna

49100

Rabin Medical Center - Beilinson Hospital, Petah Tikva

49241

Pusan National University Hospital, Busan

50134

Azienda Ospedaliero-Universitaria Careggi, Roma

50367

Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wrocławiu, Warsaw

52621

The Chaim Sheba Medical Center, Ramat Gan

53100

Azienda Ospedaliera Universitaria Senese, Siena

56126

Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara, Roma

58128

Chonnam National University Hwasun Hospital, Hwasun

59037

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

59063

Evangelisches Krankenhaus Hamm gGmbH, Hamm

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

60637

The University of Chicago Medical Center, Chicago

63100

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

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

69115

Universitätsklinikum Münster, Heidelberg

Universitätsklinikum Tübingen, Heidelberg

69120

Universitätsklinikum Heidelberg, Heidelberg

69373

Centre Léon Bérard, Lyon

69495

Centre Hospitalier Lyon-Sud, Pierre-Bénite

70124

Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari, Bari

70300

Assaf Harofeh Medical Center, Be’er Ya‘aqov

73557

Stauferklinikum Schwäbisch Gmünd, Mutlangen

75012

Hôpital Saint-Antoine, Paris

75475

Hôpital Saint-Louis, Paris

76038

Centre Henri Becquerel - Centre de Lutte Contre le Cancer, Rouen

78150

Centre Hospitalier de Versailles - Hôpital André Mignot, Le Chesnay

80131

"A.O.R.N. A. Cardarelli", Napoli

"Azienda Ospedaliera Universitaria Federico II", Roma

83301

Chang Gung Medical Foundation - Kaohsiung Branch, Kaohsiung City

84131

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

90095

University of Florida (UF) Health Shands Hospital, Gainesville

90146

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo

91120

Hadassah University Medical Center, Jerusalem

100034

Peking University First Hospital, Beijing

100853

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

119074

National University Hospital (S) Pte Ltd, Singapore

138543

Singapore General Hospital, Singapore

185019

Republican Hospital n.a.V.A. Baranov, Petrozavodsk

191024

Russian Research Institute of Hematology and Blood Transfusion, Saint Petersburg

194291

Leningrad Regional Clinic and Hospital, Saint Petersburg

197341

Almazov Federal North-West Medical Research Centre, Saint Petersburg

200025

Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School, Shanghai

200143

Spitalul Clinic Municipal Filantropia Craiova, Craiova

300020

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

300053

Tula Regional Clinical Hospital, Tula

325015

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

350001

Fujian Medical University Union Hospital, Fuzhou

390039

Ryazan Regional Clinical Hospital, Ryazan

400124

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

410012

Saratov State Medical University named after V.I. Razumovsky, Saratov

440071

Penza Regional Oncology Dispensary, Penza

450008

Henan Cancer Hospital, Zhengzhou

510030

Guangdong General Hospital, Guangzhou

540042

Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4005), Târgu Mureş

540136

Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4008), Târgu Mureş

603126

Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod

710038

Tang Du Hospital, Fourth Military Medical University, Xi'an

730030

Lanzhou University Second Hospital, Lanzhou

1169050

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

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

S2000CVB

Sanatorio Britanico, Rosario

X5000JHQ

Sanatorio Allende, Córdoba

70750-521

Hospital Amaral Carvalho, Brasília

Hospital do CEPON, Brasília

Instituto do Cancer do Estado de São Paulo, Brasília

Santa Casa de Misericórdia de Porto Alegre, Brasília

99010-260

Hospital da Cidade de Passo Fundo, Passo Fundo

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G-3G3

University of Alberta Hospital, Edmonton

V5Z 1M9

Vancouver General Hospital (VGH), Vancouver

M5G 1X5

Princess Margaret Cancer Centre, Toronto

500 05

Fakultní Nemocnice Hradec Králové, Hradec Králové

775 20

Fakultní Nemocnice Olomouc, Olomouc

708 52

Fakultní Nemocnice Ostrava, Ostrava

304 60

Fakultni Nemocnice Plzen, Pilsen

128 20

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

Unknown

Prince of Wales Hospital, Shatin

460-0001

National Hospital Organization Nagoya Medical Center, Nagoya

466-8560

Nagoya University Hospital, Nagoya

441-8570

Toyohashi Municipal Hospital, Toyohashi

790-0024

Ehime Prefectural Central Hospital, Matsuyama

910-1193

University of Fukui Hospital, Yoshida

812-8582

Kyushu University Hospital, Higashi

371-0821

Gunmaken Saiseikai Maebashi Hospital, Maebashi

371-8511

Gunma University Hospital, Maebashi

720-0001

Chugoku Central Hospital, Fukuyama

003-0006

Sapporo Hokuyu Hospital, Sapporo

236-0004

Yokohama City University Hospital, Yokohama

983-8520

National Hospital Organization Sendai Medical Center, Sendai

632-8552

Tenri Hospital, Tenri

431-3192

Hamamatsu University Hospital, Hamamatsu

113-8677

Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Bunkyō-Ku

105-0003

The Jikei University Hospital, Minato-Ku

010-8543

Akita University Hospital, Akita

030-8553

Aomori Prefectural Central Hospital, Aomori

260-0852

Chiba Aoba Municipal Hospital, Chiba

296-0041

Kameda Medical Center - Kameda General Hospital, Chiba

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

500-8513

Gifu Municipal Hospital, Gifu

892-0853

National Hospital Organization Kagoshima Medical Center, Kagoshima

650-0047

Kobe City Medical Center General Hospital, Kobe

860-0008

National Hospital Organization Kumamoto Medical Center, Kumamoto

852-8501

Nagasaki University Hospital, Nagasaki

534-0021

Osaka City General Hospital, Osaka

543-8555

Osaka Red Cross Hospital, Osaka

141-8625

NTT Medical Center Tokyo, Tokyo

31-501

Szpital Uniwersytecki w Krakowie, Krakow

76-200

Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka, Słupsk

00-957

Instytut Hematologii i Transfuzjologi, Warsaw

3000-075

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

4099-001

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

4200-072

Instituto Português Oncologia do Porto Francisco Gentil, EPE, Porto

4200-319

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

CP 46026

Hospital Universitari i Politècnic La Fe, Valencia

ME16 9QQ

Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital, Maidstone

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY

NCT02668653 - Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) | Biotech Hunter | Biotech Hunter