(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

PHASE3CompletedINTERVENTIONAL
Enrollment

367

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

February 22, 2018

Study Completion Date

September 8, 2020

Conditions
AML
Interventions
DRUG

Quizartinib

20 or 30 mg quizartinib tablets administered orally once daily

DRUG

Salvage Chemotherapy

Low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA) administered during 28-day cycles

Trial Locations (131)

100

National Taiwan University Hospital, Taipei

112

Taipei Veterans General Hospital, Taipei

404

China Medical University Hospital, Taichung

704

National Cheng Kung University Hospital, Tainan City

1083

Semmelweis Egyetem Altalanos Orvostudomanyi Kar I. Belgyogyaszati Klinika, Budapest

1200

UCL St Luc, Brussels

2060

ZNA Stuivenberg, Antwerp

2145

Westmead Hospital, Westmead

2605

The Canbera Hospital, Garran

3000

Leuven UZ Gasthuisberg, Leuven

3004

Alfred Hospital, Melbourne

4032

Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet, Debrecen

5000

Royal Adelaide Hospital, Adelaide

5011

The Queen Elizabeth Hospital, Woodville

6725

Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent Gyorgyi Albert Klinikai Kozpont, Szeged

10000

Klinička Bolinca Merkur, Zagreb

Kliničko Bolnički Centar Zagreb, Zagreb

10032

Columbia University Medical Center, New York

10043

Azienda Ospedaliero Universitaria San Luigi Gonzaga, Orbassano

10595

NY Medical College, Valhalla

11000

Klinicki Centar Srbije, Belgrade

12200

Charité Universitätsmedizin Berlin, Berlin

13353

Charité Campus Virchow Klinikum, Berlin

13385

Hopital de la Conception, Marseille

14000

CHU de Caen, Caen

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester, Rochester

15276

Uniwersytecki Szpital Kliniczny w Biatymstoku, Klinika Hematologii z Pododzialem Chorob Naczyn, Bialystok

16132

IRCCS Azienda Ospedaliera Universitaria San Martino, Genova

Opsedale San Martino di Genova, Genova

17033

Penn State Milton S Hershey Medical Center, Hershey

17822

Geisinger Medical Center, Danville

19104

University of Pennsylvania Health System, Philadelphia

20081

Samodzielny Publiczny Szpital Kliniczny Nr 1, Klinika Hematoonkologii i Transplantacji Szpiku, Lublin

20132

Ospedale San Raffaele, Milan

21000

Klinicki Centar Vojvodine, Novi Sad

21100

Ospedale di Circolo-a Fondazione Macchi, Varese

21201

University of Maryland, Baltimore

27157

Wake Forest University Baptist Health, Winston-Salem

27599

UNC Linebreger Comprehensive Cancer Center, Chapel Hill

27710

Duke Cancer Institute at Duke University Health System, Durham

28007

Hospital General Universitario Gregorio Marañon, Madrid

30322

Emory Winship Cancer Institute, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

31008

Complejo Hospitalario de Navarra, Pamplona

31059

Centre Hospitalier Universitaire Purpan, Toulouse

33604

Hopital Haut Leveque Centre Francois Magendie, Pessac

35043

Universitätsklinikum Giessen und Marburg GmbH, Marburg

37007

Hospital Clínico Universitario de Salamanca, Salamanca

37232

Vanderbilt-Ingram Cancer Center, Nashville

38043

Centre Hospitalier Universitaire Grenoble Hopital Michalon, Grenoble

38114

Klinikum Braunschweig, Braunschweig

40032

Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach Oddzial Hematologii i Transplantacji Szpiku, Katowice

40138

Università di Bologna, Bologna

41013

Hospital Universitario Virgen del Rocio, Seville

44035

Centre Hospitalier Universitaire Nantes, Nantes

44124

Arcispedale S Anna, Ferrara

45267

University of Cincinnati, Cincinnati

46026

Hospital La Fe, Valencia

46237

Franciscan Alliance, Indianapolis

48109

University of Michigan Health System, Ann Arbor

48149

Medizinische Klinik A Hämatologie Hämostaseologie Internistische Onkologie und Pneumologie, Münster

48201

Barbara Ann Karmanos Cancer Institute, Detroit

50005

Fakultni nemocnice Hradec Kralove, Hradec Králové

50134

AOU Careggi, Florence

53100

Azienda Ospedaliero Universitaria Senese, Policlinico S. Maria alle Scotte, Siena

55131

University Mainz, Mainz

55905

Mayo Clinic, Rochester

57105

Avera Cancer Institute, Sioux Falls

60590

Klinikum der Johann Wolfgang-Goethe-Universität, Frankfurt

60607

University of Illinois at Chicago, Chicago

60637

University of Chicago, Chicago

62500

Fakultni nemocnice Brno, Brno

63110

Washington University School of Medicine, St Louis

66205

University of Kansas Medical Center Research Institute Inc, Westwood

68198

University of Nebraska Medical Center, Omaha

69120

Uniklinik Heidelberg Medizinische Klinik und Poliklinik V, Heidelberg

70124

AOU Policlinico Consorziale di Bari, Bari

71103

LSU Health Sciences Center Feist Weiller Cancer Center, Shreveport

75010

Hôpital Saint Louis, Paris

75571

Hopital Saint-Antoine, Paris

76038

Centre Henri-Becquerel, Rouen

77030

MD Anderson Center, The University of Texas, Houston

77900

Fakultni nemocnice Olomouc, Olomouc

78157

Centre Hospitalier de Versailles, Le Chesnay

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

81377

LMU München Klinikum Großhadern, München

90033

University of Southern California, Norris Comprehensive Cancer Center, Los Angeles

90095

UCLA Medical Center, Los Angeles

91010

City of Hope National Medical Center, Duarte

94305

Stanford University Medical Center Stanford Comprehensive Cancer Center, Stanford

95817

UC Davis Cancer Center, Sacramento

97239

Oregon Health and Science University Knight Cancer Institute, Portland

98104

Swedish Cancer Institute, Seattle

119228

National University of Singapore, Singapore

169608

Singapore General Hospital, Singapore

06520

Yale University, New Haven

02215

Dana Farber Cancer Institute, Boston

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

Unknown

The Princess Alexandra Hospital, Brisbane

The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong

The University of Hong Kong, Queen Mary Hospital, Hong Kong

Unità Operativa di Ematologia e Unità Operativa CTMO, Cagliari

T6G 2B7

University of Alberta Hospital, Edmonton

V5Z 1M9

Vancouver General Hospital, Vancouver

M5G2M9

Princess Margaret Cancer Centre Princess Margaret Hospital, Toronto

01307

Universitatsklinikum Dresden, Dresden

06120

Universitätsklinikum Halle, Halle

07743

Universitätsklinikum Jena, Jena

04103

Universitätsklinikum Leipzig, Leipzig

00133

L'UOC di Ematologia del Policlinico Tor Vergata, Rome

00168

Policlinico Universitario Agostino Gemelli, Rome

1081 HV

VU Medisch Centrum, Amsterdam

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

3015 CE

Erasmus Medical Center, Rotterdam

463-707

Seoul National University Bundang Hospital, Seongnam-si

700-721

Kyungpook National University Hospital, Daegu

110-744

Seoul National University Hospital, Seoul

135-710

Samsung Medical Center, Seoul

137-701

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

138-736

Asan Medical Center, Seoul

07120

Hospital Son Espases, Palma

08036

Hospital Clinic I Provincial de Barcelona, Barcelona

08916

Hospital Universitari Germans Trias i Pujol, Barcelona

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

LS9 7TF

Saint James University Hospital, Leeds

SE5 9RS

King's College Hospital, London

NG51PB

Nottingham City Hospital NHS Trust, Nottingham

SM2 5PT

Royal Marsden Hospital Sutton, Sutton

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

CF14 4XW

University Hospital of Wales, Cardiff

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY