Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

PHASE3CompletedINTERVENTIONAL
Enrollment

502

Participants

Timeline

Start Date

February 5, 2008

Primary Completion Date

August 31, 2010

Study Completion Date

May 27, 2015

Conditions
Chronic Myeloid Leukemia
Interventions
DRUG

Bosutinib

500 mg once daily, by mouth (tablet) with food preferably in the morning. Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.

DRUG

imatinib

400 mg once daily, by mouth (tablet). Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.

Trial Locations (165)

100

National Taiwan University Hospital, Taipei TOC

1006

Riga Centre Of Haematology, Riga

1097

Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet, Budapest

1200

Cliniques Universitaires Saint Luc, Brussels

1426

Instituto Medico Especializado Alexander Fleming, Buenos Aires

1900

Hospital Italiano de la Plata, La Plata

2013

Clinical Haematology Unit - Department of Medicine, Soweto

Department of Cardiology, Chris Hani Baragwanath Hospital, Soweto

Department of Radiology, Chris Hani Baragwanath Hospital, Soweto

2193

University Witwatersrand and Oncology, Johannesburg

Johannesburg Hospital, Department of Medical Oncology, Parktown

4400

Josa Andras Hospital, Nyíregyháza

5000

Hospital Privado de Cordoba, Córdoba

6000

C.H.R.ST. - R. Fabiola (N-D), Charleroi

6042

CHU de Charleroi - Hopital civil Marie Curie, Lodelinsart

6198

Centro De Hematologia E Hemoterapia Da Unicamp, Campinas/ SP

7100

Centre Hospitalier de Jolimont - Lobbes, La Louvière

7400

Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly, Kaposvár

8800

H.-Hartziekenhuis Roeselare-Menen, Roeselare

9000

University Hospital Gent - Department of Hematology, Ghent

9023

Petz Aladar Megyei Oktato Korhaz, Győr

10043

Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano

10700

Division of Hematology, Department of Medicine, Bangkoknoi

13353

Charite University Medical Center - Campus Virchow Klinikum, Berlin

14000

CHU Caen - Cote de Nacre, Caen

18009

Cherkaskiy oblasniy onkologichniy dispanser, Cherkassy

20246

Univeristatsklinikum Hamburg-Eppendorf, Hamburg

20817

Center for Cancer and Blood Disorders, Bethesda

20900

Azienda Ospedaliera San Gerardo, Monza

27310

Gaziantep Universitesi Tip Fakultesi, Gaziantep

28006

Hospital De La Princesa, Madrid

28046

Hospital Universitario La Paz, Madrid

28050

Hospital de Madrid Norte-Sanchinarro Centro Integral Oncologico, Madrid

30341

Northside Hospital, Inc. - GCS/Annex, Atlanta

32806

Orlando Health, Inc., Orlando

33076

Institut Bergonie, Bordeaux

34652

Cancer Care Centers of Florida, New Port Richey

Pasco Pinellas Cancer Center, New Port Richey

34667

Cancer Care Centers of Florida, Hudson

34689

Pasco Pinellas Cancer Center, Tarpon Springs

37421

Associates In Oncology and Hematology, Chattanooga

44000

Hopital HOTEL DIEU, Nantes

45004

Complejo Hospitalario de Toledo- Servicio de Hematologia., Toledo

46010

Hospital Clinico Universitario de Valencia (CHUV), Valencia

46237

Indiana Blood and Marrow Transplantation Research Franciscan St. Francis Health Center Inc., Indianapolis

Indiana Blood and Marrow Transplantation Research, Indianapolis

48126

Henry Ford Medical Center- Fairlane, Dearborn

48183

Josephine Ford Cancer - Downriver, Brownstown

48322

Henry Ford Hospital - West Bloomfield, Detroit

49006

Clinical Assocation of Emergency Care, Dnipropetrovsk

49102

Clinical Diagnostic Laboratory of Komunalnyj Zaklad, Dnipropetrovsk

"Komunalnyj Zaklad Dnipropetrovska Miska Bagatoprofilna Klinichna Likarnja #4", Dnipropetrovsk

50006

Changhua Christian Hospital, Changhua

51101

Siouxland Hematology-Oncology Associates, LLP, Sioux City

67000

Clinique Sainte Anne, Strasbourg

67098

Hopitaux Universitaires de Strasbourg - Hopital Civil, Strasbourg

67214

Cancer Center of Kansas, Wichita

67401

Cancer Center of Kansas, Salinas

68167

III. Medizinische Klinik, Universitaetsklinikum Mannheim gGmbH, Mannheim

69437

Hopital EDOUARD HERRIOT, Lyon

78157

Centre Hospitalier de Versailles Hopital Andre Mignot, Le Chesnay

79010

Ultrasaund Educational and Diagnostic Center, Lviv

79044

Instutut Patologii Krovi to Transfuziynoi Medicinu AMN Ukraini, Lviv

Polyclinic of 5th Municipal Hospital, Lviv

81675

III. Medizinischen Klinik und Poliklinik des Klinikums Rechts der Isar der TU-MUNCHEN, München

83045

Instytut Nevidkladnoi ta Vidnovnoi Hirurgii im. P.K. Husaka NAMN Ukrainy, Viddilennja Hematologii, Donetsk

86021

Centre d'Investigation Clinique- CIC INSERM802, Poitiers

CHU de Poitiers, Poitiers

87401

San Juan Oncology Associates, Farmington

92037

UCSD Medical Center-Thornton, La Jolla

92093

UCSD Moores Cancer Center, La Jolla

92103

UCSD Medical Center-Hillcrest, San Diego

92708

Robert A Moss, MD, FACP, Inc, Fountain Valley

92801

Pacific Cancer Medical Center Inc, Anaheim

94305

Stanford Hospital and Clinics Investigational Drug Services, Stanford

Stanford Hospitals and Clinics, Stanford

Stanford University Medical Center, Stanford

95124

Ospedale Ferrarotto - Divisione di Ematologia, Catania

97000

Centro Medico de las Americas, Mérida

100730

Peking Union Medical College Hospital of Chinese Academy of Medical Sciences, Beijing

100853

The Chinese PLA General Hospital, Beijing

125167

Federal State Budget Institution Hematology Scientific Center of Minzdravsotsrazvitiya of Russia, Moscow

150062

Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital, Yaroslavl

167904

GUZ Komi Republican Oncology Center, Syktyvkar

169608

Singapore General Hospital, Singapore

185019

Republican Hospital na Baranov, Petrozavodsk

194291

Leningrad Regional Clinical Hospital, Saint Petersburg

197022

St-Petersburg Pavlov's State Medical University, Saint Petersburg

St-Petersburg State Medical University, Saint Petersburg

200025

Ruiging Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

300020

The Hematology Hospital of Chinese Academy of Medical Science, Tianjin

302013

SEAROC Cancer Center, Soni Manipal Hospital, Jaipur

344015

Rostov Regional Clinical Hospital, Rostov-on-Don

344022

Rostov State Medical University of the Minzdravsotsrazvitiya of Russia, Rostov-on-Don

411001

Jehangir Clinical Development Centre,, Pune

443095

Samara Regional Clinical Hospital M.I. Kalinin, Samara

610027

Kirov Research Institute of Hematology and Blood Transfusion of, Kirov

614077

Perm Territory State Budgetary Healthcare Inst, Perm

620102

Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

620137

Central City Hospital #7, Yekaterinburg

630087

State Novosibirsk Regional Clinical Hospital, Novosibirsk

656010

"Regional State Budgetary Healthcare Institution Barnaul City Hospital #8", Barnaul

2018601

Jikei University Hospital Daisan, Komae-shi

4313192

Hamamatsu Medical University Hospital Faculty of Medicine, Shizuoka

8111395

National Hospital Organization Kyushu Cancer Center, Fukuoka

9518520

Niigata University Medical and Dental Hospital, Niigata

9808574

Tohoku Univesity Hospital, Sendai

90211-1848

Tower Cancer Research Foundation (TCRF), Beverly Hills

41701-9466

Kentucky Cancer Clinic, Hazard

48202-2689

Henry Ford Hospital, Detroit

08003

Regional Cancer Care Associates, Cherry Hill

Study Supplies: Regional Cancer Care Associates, Cherry Hill

08876

Somerset Hematology Oncology Associates, Somerville

77030-4009

The University of Texas M.D. Anderson Cancer Center, Houston

B8000FJI

Centro de Investigaciones Oncologicas, Bahía Blanca

V5Z 1M9

Vancouver General Hospital, Vancouver

M5G 2M9

University Health Network, Princess Margaret Hospital, Toronto

H1T 2M4

Hopital Maisonneuve Rosemont, Montreal

Unknown

Instituto Oncologico del Sur, Temuco

Instituto Oncologico, Viña del Mar

Fundacion Santa Fe de Bogota, Bogota

Fundacion Cardiovascular de Colombia, Floridablanca

CIOSAD Centro de Investigaciones Oncologicas, Bogotá

Prince Of Wales Hospital, Shatin N.T.

06202

Hospital Archet 1, Nice

01307

Universitätsklinikum Carl Gustav Carus, Dresden

04103

Universitaetsklinikum Leipzig Zentrum fur Innere Medizin, Leipzig

400 012

Tata Memorial Center, Tata Memorial Hospital, Mumbai

410 210

Advanced Centre for Treatment, Research and Education in Cancer, Mumbai

302 004

Birla Cancer Centre, Jaipur

00144

Dipartimento Di Ematologia Ospedale Santo Eugenio, Roma

441-8570

Toyohashi Municipal Hospital, Toyohashi

010-8543

Akita University Hospital, Akita

920-8641

Kanazawa University Hospital, Kanazawa

589-8511

Kinki University School Of Medicine, Sayama

453-8511

Japanese Red Cross Nagoya First Hospital, Aichi

464-8681

Aichi Cancer Center Hospital, Aichi

260-8677

Chiba University Hospital, Chiba

259-1193

Tokai University Hospital, Kanagawa

852-8501

Nagasaki University Hospital, Nagasaki

565-0871

Osaka University Hospital, Osaka

113-8677

Tokyo Metropolitan Cancer & Infectious Disease Centre Komagome Hp, Tokyo

LT-08661

Hematology, Oncology & Transfusion Medicine Center, Vilnius

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

40-032

Samodzielny Publiczny Szpital Kliniczny Im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego, Katowice

31-501

SP ZOZ Szpital Uniwersytecki w Krakowie, Krakow

93-510

Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Lodz

20-081

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin

137-701

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

08036

Hospital Universitari Clinic de Barcelona, Barcelona

06100

Hacettepe Universitesi Tip Fakultesi, Ankara

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi, Ankara

01023

Oleksandrovska clinical hospital cardiological rehabilitation department, Kiev

03115

"Institut Klinichnoi Radiologii DU Natsionalnyj Naukovyj Centr Radiacijnoi Medicini NAMN Ukraini", Kyiv

Institut Klinichnoi Radiologii Naukovogo Centru Radiacijnoi Medicini NAMN Ukraini, Kyiv

Institut Klinichnoi Radiologii Naukovogo, Kyiv

04112

Miska klinichna likarnja # 9, Kyiv

NG5 1PB

3rd Floor Centre for Clinical Haematology, Nottingham

NG5 8RX

The Park Hospital, Nottingham

W12 0HS

Hammersmith Hospital Clinical Trial Units, Hammersmith

Hammersmith Hospital, London

B75 7RR

Good Hope Hospital, Birmingham

B9 5SS

Birmingham Heartlands Hospital, Birmingham

LS9 7TF

Department of Haematology - Level 3, Bexley Wing, Leeds

SE1 9RT

Department of Haematology, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

lead

Pfizer

INDUSTRY