Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)

PHASE3CompletedINTERVENTIONAL
Enrollment

666

Participants

Timeline

Start Date

January 29, 2013

Primary Completion Date

August 12, 2014

Study Completion Date

May 28, 2021

Conditions
Leukemia, Myeloid, Acute
Interventions
DRUG

Placebo

Placebo matching Volasertib

DRUG

Volasertib

Volasertib

DRUG

Cytarabine

Cytarabine

Trial Locations (122)

100

National Taiwan University Hospital, Taipei

112

Mackay Memorial Hospital, Taipei

500

Chang-Hua Christian Hospital, Changhua

1083

Semmelweis University, Budapest

1130

Hospital Hietzing, Vienna

1200

Brussels - UNIV Saint-Luc, Brussels

3000

UZ Leuven, Leuven

3500

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt

4000

Centre Hospitalier Universitaire de Liège, Liège

5530

Yvoir - UNIV UCL de Mont-Godinne, Yvoir

6725

Univ. of Szeged, 2nd Dept. of Internal Med., Haematology, Szeged

7100

Haine-St-Paul - HOSP Jolimont, Haine-Saint-Paul

8000

AZ Sint-Jan Brugge, Bruges

8036

LKH-Univ. Hospital Graz, Graz

8700

LKH Leoben, Leoben

8800

Roeselare - HOSP AZ Delta, Roeselare

9024

Petz Aldar Hospital, 2nd Dept. of Internal Med., Haematology, Győr

10126

AO Città della Salute e della, Torino

11526

"General Hospital of Athens Laiko", Athens

13273

INS Paoli-Calmettes, Marseille

13353

Med. Klinik m.S. Hämatologie und Onkologie, Berlin

14000

HOP Côte de Nacre, Caen

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

20521

TYKS, Sisätautien klinikka, Turku

24105

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel

25123

A.O. Spedali Civili di Brescia, Brescia

26504

University of Patras Medical School, Pátrai

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital La Paz, Madrid

30625

Medizinische Hochschule Hannover, Hanover

31059

INS Universitaire du Cancer, Toulouse

33604

HOP Haut-Lévêque, Pessac

35033

HOP Pontchaillou, Rennes

35043

Universitätsklinikum Gießen und Marburg GmbH, Marburg

37007

Hospital Universitario de Salamanca, Salamanca

37075

Universitätsmedizin Göttingen, Georg-August-Universität, Göttingen

37232

Henry-Joyce Cancer Clinic, Nashville

38114

Städtisches Klinikum Braunschweig gGmbH, Braunschweig

38700

HOP Michallon, La Tronche

44000

HOP Nantes, Hémato, Nantes, Nantes

45147

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH, Essen

46009

Hospital Politècnic La Fe, Valencia

48149

Universitätsklinikum Münster, Münster

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

55805

St. Luke's Hospital Association of Duluth, Inc., Duluth

57010

"General Hospital of Thessaloniki G. Papanikolaou", Thessaloniki

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

64460

Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey

69120

Universitätsklinikum Heidelberg, Heidelberg

69495

HOP Lyon Sud, Pierre-Bénite

70376

Robert-Bosch-Krankenhaus GmbH, Stuttgart

75012

HOP Saint-Antoine, Paris

77030

The University of Texas MD Anderson Cancer Center, Houston

78052

Schwarzwald-Baar Klinikum, Villingen-Schwenningen

78157

HOP André Mignot, Le Chesnay

80054

HOP Amiens-Picardie Sud, Amiens

81675

Klinikum rechts der Isar der Technischen Universität München, München

86156

Universitätsklinikum Augsburg, Augsburg

87042

HOP Dupuytren 1, Limoges

89081

Universitätsklinikum Ulm, Ulm

91054

Universitätsklinikum Erlangen, Erlangen

93053

Universitätsklinikum Regensburg, Regensburg

115478

"FSBI N.N Blokhin Med.Res.Cent.Onc.MoH of RF", Moscow

194291

Leningrad Reg. Clin. Hosp., Oncohematology Department No. 2, Saint Petersburg

400012

Tata Memorial Hospital, Mumbai

560034

St. John Medical College and hospital, Bangalore

603126

Nizhniy Novgorod Reg. Clinical Hospital, Dept. Haematology, Nizhny Novgorod

664079

Regional Clinical Hospital 'The Badge of Honor Order', Irkutsk

90095-1678

University of California, Los Angeles

M5500AYB

Fundacion COIR, Mendoza

T4000HXU

Hospital Central de Salud Zenón Santillan, San Miguel de Tucumán

17210-080

Hospital Doutor Amaral Carvalho, Jaú

90470-340

Hospital Mãe de Deus, Porto Alegre

14048-900

H.C.da Fac. de Medicina de Ribeirao Preto, Ribeirão Preto

T6G 2G3

University of Alberta Hospital (University of Alberta), Edmonton

V5Z 1M9

Vancouver General Hospital, Vancouver

H1T 2M4

Maisonneuve-Rosemont Hospital, Montreal

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H3G 1A4

Montreal General Hospital - McGill University Health Centre, Montreal

500 05

Hospital Hradec Kralove, Hradec Králové

304 60

University Hospital Plzen, Plzen-Lochotin, Plzen - Lochotin

100 34

Univ. Hospital Kralovske Vinohrady, Prague

00290

Meilahden sairaala, Helsinki

06120

Martin-Luther-Universität Halle-Wittenberg, Halle

115 27

"General Hospital of Athens G. Gennimatas", Athens

45 500

Univ. Gen. Hosp. of Ioannina, Ioannina

460-0001

National Hospital Organization Nagoya Medical Center, Aichi, Nagoya

466-8650

Japanese Red Cross Nagoya Daini Hospital, Aichi, Nagoya

010-8543

Akita University Hospital, Akita, Akita

910-1193

University of Fukui Hospital, Fukui, Yoshida-gun

812-8582

Kyushu University Hospital, Fukuoka, Fukuoka

650-0017

Kobe University Hospital, Hyogo, Kobe

259-1193

Tokai University Hospital, Kanagawa, Isehara

232-0024

Yokohama City University Medical Center, Kanagawa, Yokohama

980-8547

Tohoku University Hospital, Miyagi, Sendai

852-8523

Nagasaki University Hospital, Nagasaki, Nagasaki

710-8602

Kurashiki Central Hospital, Okayama, Kurashiki

700-8558

Okayama University Hospital, Okayama, Okayama

545-8586

Osaka City University Hospital, Osaka, Osaka

104-0045

National Cancer Center Hospital, Tokyo, Chuo-ku

141-8625

NTT Medical Center Tokyo, Tokyo, Sinagawa-ku

1081 HV

Amsterdam UMC Locatie VUMC, Amsterdam

N-5021

Haukeland Universitetssykehus, Bergen

N-1714

Sykehuset Østfold Kalnes, Grålum

93-510

Reg. Specialist Hospital of M. Kopernik, Dept. Haematology, Lodz

87-100

City Hospital Torun, Department of Hematology, Torun

1649-035

CHULN, EPE - Hospital de Santa Maria, Lisbon

4099-001

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

4200-072

IPO Porto Francisco Gentil, EPE, Porto

4202-451

Centro Hospitalar Universitário São João,EPE, Porto

0044

Netcare Pretoria East Hospital, Moreleta Park, Pretoria

519-763

Chonnam National University Hwasun Hospital, Hwasun

06591

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

110-744

Seoul National University Hospital, Seoul

120-752

Severance Hospital, Seoul

135-710

Samsung Medical Center, Seoul

138-736

Asan Medical Center, Seoul

08916

Hospital Germans Trias i Pujol, Badalona

08025

Hospital Santa Creu i Sant Pau, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clínic de Barcelona, Barcelona

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY