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Spots Global Cancer Trial Database for Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

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Trial Identification

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

Official Title: A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA

Study ID: NCT00574873

Interventions

Bosutinib
imatinib

Study Description

Brief Summary: Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Pacific Cancer Medical Center Inc, Anaheim, California, United States

Tower Cancer Research Foundation (TCRF), Beverly Hills, California, United States

Robert A Moss, MD, FACP, Inc, Fountain Valley, California, United States

UCSD Medical Center-Thornton, La Jolla, California, United States

UCSD Moores Cancer Center, La Jolla, California, United States

UCSD Medical Center-Hillcrest, San Diego, California, United States

Stanford Hospital and Clinics Investigational Drug Services, Stanford, California, United States

Stanford Hospitals and Clinics, Stanford, California, United States

Stanford University Medical Center, Stanford, California, United States

Cancer Care Centers of Florida, Hudson, Florida, United States

Cancer Care Centers of Florida, New Port Richey, Florida, United States

Pasco Pinellas Cancer Center, New Port Richey, Florida, United States

Orlando Health, Inc., Orlando, Florida, United States

Pasco Pinellas Cancer Center, Tarpon Springs, Florida, United States

Northside Hospital, Inc. - GCS/Annex, Atlanta, Georgia, United States

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

Indiana Blood and Marrow Transplantation Research, Indianapolis, Indiana, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States

Cancer Center of Kansas, Salinas, Kansas, United States

Cancer Center of Kansas, Wichita, Kansas, United States

Kentucky Cancer Clinic, Hazard, Kentucky, United States

Center for Cancer and Blood Disorders, Bethesda, Maryland, United States

Josephine Ford Cancer - Downriver, Brownstown, Michigan, United States

Henry Ford Medical Center- Fairlane, Dearborn, Michigan, United States

Henry Ford Hospital, Detroit, Michigan, United States

Henry Ford Hospital - West Bloomfield, Detroit, Michigan, United States

Regional Cancer Care Associates, Cherry Hill, New Jersey, United States

Study Supplies: Regional Cancer Care Associates, Cherry Hill, New Jersey, United States

Somerset Hematology Oncology Associates, Somerville, New Jersey, United States

San Juan Oncology Associates, Farmington, New Mexico, United States

Associates In Oncology and Hematology, Chattanooga, Tennessee, United States

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

Hospital Italiano de la Plata, La Plata, Buenos Aires, Argentina

Hospital Privado de Cordoba, Cordoba, Prov. DE Cordoba, Argentina

Centro de Investigaciones Oncologicas, Bahia Blanca, Provincia Buenos Aires, Argentina

Instituto Medico Especializado Alexander Fleming, Buenos Aires, , Argentina

Cliniques Universitaires Saint Luc, Brussels, , Belgium

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

University Hospital Gent - Department of Hematology, Gent, , Belgium

Centre Hospitalier de Jolimont - Lobbes, La Louviere, , Belgium

CHU de Charleroi - Hopital civil Marie Curie, Lodelinsart, , Belgium

H.-Hartziekenhuis Roeselare-Menen, Roeselare, , Belgium

Centro De Hematologia E Hemoterapia Da Unicamp, Campinas/ SP, , Brazil

Vancouver General Hospital, Vancouver, British Columbia, Canada

University Health Network, Princess Margaret Hospital, Toronto, Ontario, Canada

Hopital Maisonneuve Rosemont, Montreal, Quebec, Canada

Instituto Oncologico del Sur, Temuco, , Chile

Instituto Oncologico, Vina del Mar, , Chile

Ruiging Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, P.R. China, China

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

The Chinese PLA General Hospital, Beijing, , China

The Hematology Hospital of Chinese Academy of Medical Science, Tianjin, , China

Fundacion Santa Fe de Bogota, Bogota, Cundinamarca, Colombia

Fundacion Cardiovascular de Colombia, Floridablanca, Santander, Colombia

CIOSAD Centro de Investigaciones Oncologicas, Bogota, , Colombia

Institut Bergonie, Bordeaux, , France

CHU Caen - Cote de Nacre, Caen, , France

Centre Hospitalier de Versailles Hopital Andre Mignot, Le Chesnay Cedex, , France

Hopital EDOUARD HERRIOT, Lyon, , France

Hopital HOTEL DIEU, Nantes, , France

Hospital Archet 1, Nice Cedex 3, , France

Centre d'Investigation Clinique- CIC INSERM802, Poitiers, , France

CHU de Poitiers, Poitiers, , France

Clinique Sainte Anne, Strasbourg, , France

Hopitaux Universitaires de Strasbourg - Hopital Civil, Strasbourg, , France

Charite University Medical Center - Campus Virchow Klinikum, Berlin, , Germany

Universitätsklinikum Carl Gustav Carus, Dresden, , Germany

Univeristatsklinikum Hamburg-Eppendorf, Hamburg, , Germany

Universitaetsklinikum Leipzig Zentrum fur Innere Medizin, Leipzig, , Germany

III. Medizinische Klinik, Universitaetsklinikum Mannheim gGmbH, Mannheim, , Germany

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

Prince Of Wales Hospital, Shatin N.T., , Hong Kong

Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet, Budapest, , Hungary

Petz Aladar Megyei Oktato Korhaz, Gyor, , Hungary

Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly, Kaposvar, , Hungary

Josa Andras Hospital, Nyiregyhaza, , Hungary

Tata Memorial Center, Tata Memorial Hospital, Mumbai, Maharashtra, India

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

Jehangir Clinical Development Centre,, Pune, Maharashtra, India

Birla Cancer Centre, Jaipur, Rajasthan, India

SEAROC Cancer Center, Soni Manipal Hospital, Jaipur, Rajasthan, India

Azienda Ospedaliera San Gerardo, Monza, Lombardia, Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano, Torino, Italy

Ospedale Ferrarotto - Divisione di Ematologia, Catania, , Italy

Dipartimento Di Ematologia Ospedale Santo Eugenio, Roma, , Italy

Toyohashi Municipal Hospital, Toyohashi, Aichi, Japan

Akita University Hospital, Akita City, Akita, Japan

National Hospital Organization Kyushu Cancer Center, Fukuoka-Shi, Fukuoka, Japan

Kanazawa University Hospital, Kanazawa, Ishikawa, Japan

Tohoku Univesity Hospital, Sendai, Miyagi, Japan

Kinki University School Of Medicine, Osakasayama, Osaka, Japan

Jikei University Hospital Daisan, Komae-shi, Tokyo, Japan

Japanese Red Cross Nagoya First Hospital, Aichi, , Japan

Aichi Cancer Center Hospital, Aichi, , Japan

Chiba University Hospital, Chiba, , Japan

Tokai University Hospital, Kanagawa, , Japan

Nagasaki University Hospital, Nagasaki, , Japan

Niigata University Medical and Dental Hospital, Niigata, , Japan

Osaka University Hospital, Osaka, , Japan

Hamamatsu Medical University Hospital Faculty of Medicine, Shizuoka, , Japan

Tokyo Metropolitan Cancer & Infectious Disease Centre Komagome Hp, Tokyo, , Japan

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

Riga Centre Of Haematology, Riga, , Latvia

Hematology, Oncology & Transfusion Medicine Center, Vilnius, , Lithuania

Centro Medico de las Americas, Merida, , Mexico

Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland

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

SP ZOZ Szpital Uniwersytecki w Krakowie, Krakow, , Poland

Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Lodz, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, , Poland

GUZ Komi Republican Oncology Center, Syktyvkar, KOMI Republic, Russian Federation

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

Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg, , Russian Federation

Central City Hospital #7, Ekaterinburg, , Russian Federation

Kirov Research Institute of Hematology and Blood Transfusion of, Kirov, , Russian Federation

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

State Novosibirsk Regional Clinical Hospital, Novosibirsk, , Russian Federation

Perm Territory State Budgetary Healthcare Inst, Perm, , Russian Federation

Republican Hospital na Baranov, Petrozavodsk, , Russian Federation

Rostov Regional Clinical Hospital, Rostov-on-Don, , Russian Federation

Rostov State Medical University of the Minzdravsotsrazvitiya of Russia, Rostov-On-Don, , Russian Federation

Leningrad Regional Clinical Hospital, Saint Petersburg, , Russian Federation

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

St-Petersburg State Medical University, Saint Petersburg, , Russian Federation

Samara Regional Clinical Hospital M.I. Kalinin, Samara, , Russian Federation

St-Petersburg Pavlov's State Medical University, St. Petersburg, , Russian Federation

Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital, Yaroslavl, , Russian Federation

Singapore General Hospital, Singapore, , Singapore

University Witwatersrand and Oncology, Johannesburg, , South Africa

Johannesburg Hospital, Department of Medical Oncology, Parktown, , South Africa

Clinical Haematology Unit - Department of Medicine, Soweto, , South Africa

Department of Cardiology, Chris Hani Baragwanath Hospital, Soweto, , South Africa

Department of Radiology, Chris Hani Baragwanath Hospital, Soweto, , South Africa

Hospital Universitari Clinic de Barcelona, Barcelona, , Spain

Hospital De La Princesa, Madrid, , Spain

Hospital Universitario La Paz, Madrid, , Spain

Hospital de Madrid Norte-Sanchinarro Centro Integral Oncologico, Madrid, , Spain

Complejo Hospitalario de Toledo- Servicio de Hematologia., Toledo, , Spain

Hospital Clinico Universitario de Valencia (CHUV), Valencia, , Spain

Changhua Christian Hospital, Changhua City, , Taiwan

National Taiwan University Hospital, Taipei TOC, , Taiwan

Division of Hematology, Department of Medicine, Bangkoknoi, Bangkok, Thailand

Hacettepe Universitesi Tip Fakultesi, Ankara, Sihhiye, Turkey

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi, Ankara, , Turkey

Gaziantep Universitesi Tip Fakultesi, Gaziantep, , Turkey

Cherkaskiy oblasniy onkologichniy dispanser, Cherkassy, , Ukraine

Clinical Assocation of Emergency Care, Dnipropetrovsk, , Ukraine

Clinical Diagnostic Laboratory of Komunalnyj Zaklad, Dnipropetrovsk, , Ukraine

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

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

Oleksandrovska clinical hospital cardiological rehabilitation department, Kiev, , Ukraine

Miska klinichna likarnja # 9, Kyev, , Ukraine

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

Institut Klinichnoi Radiologii Naukovogo Centru Radiacijnoi Medicini NAMN Ukraini, Kyiv, , Ukraine

Institut Klinichnoi Radiologii Naukovogo, Kyiv, , Ukraine

Ultrasaund Educational and Diagnostic Center, Lviv, , Ukraine

Instutut Patologii Krovi to Transfuziynoi Medicinu AMN Ukraini, Lviv, , Ukraine

Polyclinic of 5th Municipal Hospital, Lviv, , Ukraine

3rd Floor Centre for Clinical Haematology, Nottingham, EAST Midlands, United Kingdom

The Park Hospital, Nottingham, EAST Midlands, United Kingdom

Hammersmith Hospital Clinical Trial Units, Hammersmith, London, United Kingdom

Good Hope Hospital, Birmingham, WEST Midlands, United Kingdom

Birmingham Heartlands Hospital, Birmingham, WEST Midlands, United Kingdom

Department of Haematology - Level 3, Bexley Wing, Leeds, WEST Yorkshire, United Kingdom

Department of Haematology, London, , United Kingdom

Hammersmith Hospital, London, , United Kingdom

Contact Details

Name: Pfizer CT.gov Call Center

Affiliation: Pfizer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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