Myeloproliferative Neoplasms Clinical Trial

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

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 (leukemia-cml/" >CML). The primary endpoint is cytogenetic response rate at one year.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.
Diagnosis of CML chronic phase confirmed.
Adequate hepatic and renal function.
Able to take oral tablets.

Exclusion Criteria:

Exclusions include Philadelphia negative CML.
Prior anti-leukemia treatment.
Prior stem cell transplant.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

502

Study ID:

NCT00574873

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 143 Locations for this study

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Pacific Cancer Medical Center Inc
Anaheim California, 92801, United States
Tower Cancer Research Foundation (TCRF)
Beverly Hills California, 90211, United States
Robert A Moss, MD, FACP, Inc
Fountain Valley California, 92708, United States
UCSD Medical Center-Thornton
La Jolla California, 92037, United States
UCSD Moores Cancer Center
La Jolla California, 92093, United States
UCSD Medical Center-Hillcrest
San Diego California, 92103, United States
Stanford Hospital and Clinics Investigational Drug Services
Stanford California, 94305, United States
Stanford Hospitals and Clinics
Stanford California, 94305, United States
Stanford University Medical Center
Stanford California, 94305, United States
Cancer Care Centers of Florida
Hudson Florida, 34667, United States
Cancer Care Centers of Florida
New Port Richey Florida, 34652, United States
Pasco Pinellas Cancer Center
New Port Richey Florida, 34652, United States
Orlando Health, Inc.
Orlando Florida, 32806, United States
Pasco Pinellas Cancer Center
Tarpon Springs Florida, 34689, United States
Northside Hospital, Inc. - GCS/Annex
Atlanta Georgia, 30341, United States
Indiana Blood and Marrow Transplantation Research Franciscan St. Francis Health Center Inc.
Indianapolis Indiana, 46237, United States
Indiana Blood and Marrow Transplantation Research
Indianapolis Indiana, 46237, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Cancer Center of Kansas
Salinas Kansas, 67401, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Kentucky Cancer Clinic
Hazard Kentucky, 41701, United States
Center for Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Josephine Ford Cancer - Downriver
Brownstown Michigan, 48183, United States
Henry Ford Medical Center- Fairlane
Dearborn Michigan, 48126, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Henry Ford Hospital - West Bloomfield
Detroit Michigan, 48322, United States
Regional Cancer Care Associates
Cherry Hill New Jersey, 08003, United States
Study Supplies: Regional Cancer Care Associates
Cherry Hill New Jersey, 08003, United States
Somerset Hematology Oncology Associates
Somerville New Jersey, 08876, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
Associates In Oncology and Hematology
Chattanooga Tennessee, 37421, United States
The University of Texas M.D. Anderson Cancer Center
Houston Texas, 77030, United States
Hospital Italiano de la Plata
La Plata Buenos Aires, 1900, Argentina
Hospital Privado de Cordoba
Cordoba Prov. DE Cordoba, 5000, Argentina
Centro de Investigaciones Oncologicas
Bahia Blanca Provincia Buenos Aires, B8000, Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires , 1426, Argentina
Cliniques Universitaires Saint Luc
Brussels , 1200, Belgium
C.H.R.ST. - R. Fabiola (N-D)
Charleroi , 6000, Belgium
University Hospital Gent - Department of Hematology
Gent , 9000, Belgium
Centre Hospitalier de Jolimont - Lobbes
La Louviere , 7100, Belgium
CHU de Charleroi - Hopital civil Marie Curie
Lodelinsart , 6042, Belgium
H.-Hartziekenhuis Roeselare-Menen
Roeselare , 8800, Belgium
Centro De Hematologia E Hemoterapia Da Unicamp
Campinas/ SP , 6198, Brazil
Vancouver General Hospital
Vancouver British Columbia, V5Z 1, Canada
University Health Network, Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Hopital Maisonneuve Rosemont
Montreal Quebec, H1T 2, 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, 20002, China
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing , 10073, China
The Chinese PLA General Hospital
Beijing , 10085, China
The Hematology Hospital of Chinese Academy of Medical Science
Tianjin , 30002, 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 , 33076, France
CHU Caen - Cote de Nacre
Caen , 14000, France
Centre Hospitalier de Versailles Hopital Andre Mignot
Le Chesnay Cedex , 78157, France
Hopital EDOUARD HERRIOT
Lyon , 69437, France
Hopital HOTEL DIEU
Nantes , 44000, France
Hospital Archet 1
Nice Cedex 3 , 06202, France
Centre d'Investigation Clinique- CIC INSERM802
Poitiers , 86021, France
CHU de Poitiers
Poitiers , 86021, France
Clinique Sainte Anne
Strasbourg , 67000, France
Hopitaux Universitaires de Strasbourg - Hopital Civil
Strasbourg , 67098, France
Charite University Medical Center - Campus Virchow Klinikum
Berlin , 13353, Germany
Universitätsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Univeristatsklinikum Hamburg-Eppendorf
Hamburg , 20246, Germany
Universitaetsklinikum Leipzig Zentrum fur Innere Medizin
Leipzig , 04103, Germany
III. Medizinische Klinik, Universitaetsklinikum Mannheim gGmbH
Mannheim , 68167, Germany
III. Medizinischen Klinik und Poliklinik des Klinikums Rechts der Isar der TU-MUNCHEN
Muenchen , 81675, Germany
Prince Of Wales Hospital
Shatin N.T. , , Hong Kong
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
Budapest , 1097, Hungary
Petz Aladar Megyei Oktato Korhaz
Gyor , 9023, Hungary
Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
Kaposvar , 7400, Hungary
Josa Andras Hospital
Nyiregyhaza , 4400, Hungary
Tata Memorial Center, Tata Memorial Hospital
Mumbai Maharashtra, 400 0, India
Advanced Centre for Treatment, Research and Education in Cancer
Mumbai Maharashtra, 410 2, India
Jehangir Clinical Development Centre,
Pune Maharashtra, 41100, India
Birla Cancer Centre
Jaipur Rajasthan, 302 0, India
SEAROC Cancer Center, Soni Manipal Hospital
Jaipur Rajasthan, 30201, India
Azienda Ospedaliera San Gerardo
Monza Lombardia, 20900, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano Torino, 10043, Italy
Ospedale Ferrarotto - Divisione di Ematologia
Catania , 95124, Italy
Dipartimento Di Ematologia Ospedale Santo Eugenio
Roma , 00144, Italy
Toyohashi Municipal Hospital
Toyohashi Aichi, 441-8, Japan
Akita University Hospital
Akita City Akita, 010-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka-Shi Fukuoka, 81113, Japan
Kanazawa University Hospital
Kanazawa Ishikawa, 920-8, Japan
Tohoku Univesity Hospital
Sendai Miyagi, 98085, Japan
Kinki University School Of Medicine
Osakasayama Osaka, 589-8, Japan
Jikei University Hospital Daisan
Komae-shi Tokyo, 20186, Japan
Japanese Red Cross Nagoya First Hospital
Aichi , 453-8, Japan
Aichi Cancer Center Hospital
Aichi , 464-8, Japan
Chiba University Hospital
Chiba , 260-8, Japan
Tokai University Hospital
Kanagawa , 259-1, Japan
Nagasaki University Hospital
Nagasaki , 852-8, Japan
Niigata University Medical and Dental Hospital
Niigata , 95185, Japan
Osaka University Hospital
Osaka , 565-0, Japan
Hamamatsu Medical University Hospital Faculty of Medicine
Shizuoka , 43131, Japan
Tokyo Metropolitan Cancer & Infectious Disease Centre Komagome Hp
Tokyo , 113-8, Japan
The Catholic University of Korea, Seoul St. Mary's Hospital/Division of Hematology
Seoul , 137-7, Korea, Republic of
Riga Centre Of Haematology
Riga , 1006, Latvia
Hematology, Oncology & Transfusion Medicine Center
Vilnius , LT-08, Lithuania
Centro Medico de las Americas
Merida , 97000, Mexico
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-95, Poland
Samodzielny Publiczny Szpital Kliniczny Im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego
Katowice , 40-03, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow , 31-50, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz , 93-51, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin , 20-08, Poland
GUZ Komi Republican Oncology Center
Syktyvkar KOMI Republic, 16790, Russian Federation
Regional State Budgetary Healthcare Institution "Barnaul City Hospital #8"
Barnaul , 65601, Russian Federation
Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg , 62010, Russian Federation
Central City Hospital #7
Ekaterinburg , 62013, Russian Federation
Kirov Research Institute of Hematology and Blood Transfusion of
Kirov , 61002, Russian Federation
Federal State Budget Institution Hematology Scientific Center of Minzdravsotsrazvitiya of Russia
Moscow , 12516, Russian Federation
State Novosibirsk Regional Clinical Hospital
Novosibirsk , 63008, Russian Federation
Perm Territory State Budgetary Healthcare Inst
Perm , 61407, Russian Federation
Republican Hospital na Baranov
Petrozavodsk , 18501, Russian Federation
Rostov Regional Clinical Hospital
Rostov-on-Don , 34401, Russian Federation
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
Rostov-On-Don , 34402, Russian Federation
Leningrad Regional Clinical Hospital
Saint Petersburg , 19429, Russian Federation
St-Petersburg Pavlov's State Medical University
Saint Petersburg , 19702, Russian Federation
St-Petersburg State Medical University
Saint Petersburg , 19702, Russian Federation
Samara Regional Clinical Hospital M.I. Kalinin
Samara , 44309, Russian Federation
St-Petersburg Pavlov's State Medical University
St. Petersburg , 19702, Russian Federation
Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital
Yaroslavl , 15006, Russian Federation
Singapore General Hospital
Singapore , 16960, Singapore
University Witwatersrand and Oncology
Johannesburg , 2193, South Africa
Johannesburg Hospital, Department of Medical Oncology
Parktown , 2193, South Africa
Clinical Haematology Unit - Department of Medicine
Soweto , 2013, South Africa
Department of Cardiology, Chris Hani Baragwanath Hospital
Soweto , 2013, South Africa
Department of Radiology, Chris Hani Baragwanath Hospital
Soweto , 2013, South Africa
Hospital Universitari Clinic de Barcelona
Barcelona , 08036, Spain
Hospital De La Princesa
Madrid , 28006, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital de Madrid Norte-Sanchinarro Centro Integral Oncologico
Madrid , 28050, Spain
Complejo Hospitalario de Toledo- Servicio de Hematologia.
Toledo , 45004, Spain
Hospital Clinico Universitario de Valencia (CHUV)
Valencia , 46010, Spain
Changhua Christian Hospital
Changhua City , 50006, Taiwan
National Taiwan University Hospital
Taipei TOC , 100, Taiwan
Division of Hematology, Department of Medicine
Bangkoknoi Bangkok, 10700, Thailand
Hacettepe Universitesi Tip Fakultesi
Ankara Sihhiye, 06100, Turkey
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara , 06100, Turkey
Gaziantep Universitesi Tip Fakultesi
Gaziantep , 27310, Turkey
Cherkaskiy oblasniy onkologichniy dispanser
Cherkassy , 18009, Ukraine
Clinical Assocation of Emergency Care
Dnipropetrovsk , 49006, Ukraine
Clinical Diagnostic Laboratory of Komunalnyj Zaklad
Dnipropetrovsk , 49102, Ukraine
Komunalnyj Zaklad "Dnipropetrovska Miska Bagatoprofilna Klinichna Likarnja #4"
Dnipropetrovsk , 49102, Ukraine
Instytut Nevidkladnoi ta Vidnovnoi Hirurgii im. P.K. Husaka NAMN Ukrainy, Viddilennja Hematologii
Donetsk , 83045, Ukraine
Oleksandrovska clinical hospital cardiological rehabilitation department
Kiev , 01023, Ukraine
Miska klinichna likarnja # 9
Kyev , 04112, Ukraine
Institut Klinichnoi Radiologii DU "Natsionalnyj Naukovyj Centr Radiacijnoi Medicini NAMN Ukraini"
Kyiv , 03115, Ukraine
Institut Klinichnoi Radiologii Naukovogo Centru Radiacijnoi Medicini NAMN Ukraini
Kyiv , 03115, Ukraine
Institut Klinichnoi Radiologii Naukovogo
Kyiv , 03115, Ukraine
Ultrasaund Educational and Diagnostic Center
Lviv , 79010, Ukraine
Instutut Patologii Krovi to Transfuziynoi Medicinu AMN Ukraini
Lviv , 79044, Ukraine
Polyclinic of 5th Municipal Hospital
Lviv , 79044, Ukraine
3rd Floor Centre for Clinical Haematology
Nottingham EAST Midlands, NG5 1, United Kingdom
The Park Hospital
Nottingham EAST Midlands, NG5 8, United Kingdom
Hammersmith Hospital Clinical Trial Units
Hammersmith London, W12 0, United Kingdom
Good Hope Hospital
Birmingham WEST Midlands, B75 7, United Kingdom
Birmingham Heartlands Hospital
Birmingham WEST Midlands, B9 5S, United Kingdom
Department of Haematology - Level 3, Bexley Wing
Leeds WEST Yorkshire, LS9 7, United Kingdom
Department of Haematology
London , SE1 9, United Kingdom
Hammersmith Hospital
London , W12 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

502

Study ID:

NCT00574873

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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