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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR