Clinical trial NCT00574873: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Myeloid Leukemia
Keywords: Bosutinib
imatinib
CML
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2007-12-17
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1
timeFrame: Year 1 (48 weeks)
Secondary outcomes:
measure: Percentage of Participants With Major Molecular Response (MMR) at Year 1
timeFrame: Year 1 (48 weeks)
measure: Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks
timeFrame: 192 weeks
measure: Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks
timeFrame: 192 weeks
measure: Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks
timeFrame: 144 weeks
measure: Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks
timeFrame: 192 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center Inc
state: California
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation (TCRF)
state: California
city: Fountain Valley
country: United States
facility: Robert A Moss, MD, FACP, Inc
state: California
city: La Jolla
country: United States
facility: UCSD Medical Center-Thornton
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Center-Hillcrest
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics Investigational Drug Services
state: California
city: Stanford
country: United States
facility: Stanford Hospitals and Clinics
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Hudson
country: United States
facility: Cancer Care Centers of Florida
state: Florida
city: New Port Richey
country: United States
facility: Cancer Care Centers of Florida
state: Florida
city: New Port Richey
country: United States
facility: Pasco Pinellas Cancer Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Tarpon Springs
country: United States
facility: Pasco Pinellas Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital, Inc. - GCS/Annex
state: Georgia
city: Indianapolis
country: United States
facility: Indiana Blood and Marrow Transplantation Research Franciscan St. Francis Health Center Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Blood and Marrow Transplantation Research
state: Indiana
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates, LLP
state: Iowa
city: Salinas
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Brownstown
country: United States
facility: Josephine Ford Cancer - Downriver
state: Michigan
city: Dearborn
country: United States
facility: Henry Ford Medical Center- Fairlane
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital - West Bloomfield
state: Michigan
city: Cherry Hill
country: United States
facility: Regional Cancer Care Associates
state: New Jersey
city: Cherry Hill
country: United States
facility: Study Supplies: Regional Cancer Care Associates
state: New Jersey
city: Somerville
country: United States
facility: Somerset Hematology Oncology Associates
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Chattanooga
country: United States
facility: Associates In Oncology and Hematology
state: Tennessee
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: La Plata
country: Argentina
facility: Hospital Italiano de la Plata
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Hospital Privado de Cordoba
state: Prov. DE Cordoba
city: Bahia Blanca
country: Argentina
facility: Centro de Investigaciones Oncologicas
state: Provincia Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Charleroi
country: Belgium
facility: C.H.R.ST. - R. Fabiola (N-D)
city: Gent
country: Belgium
facility: University Hospital Gent - Department of Hematology
city: La Louviere
country: Belgium
facility: Centre Hospitalier de Jolimont - Lobbes
city: Lodelinsart
country: Belgium
facility: CHU de Charleroi - Hopital civil Marie Curie
city: Roeselare
country: Belgium
facility: H.-Hartziekenhuis Roeselare-Menen
city: Campinas/ SP
country: Brazil
facility: Centro De Hematologia E Hemoterapia Da Unicamp
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve Rosemont
state: Quebec
city: Temuco
country: Chile
facility: Instituto Oncologico del Sur
city: Vina del Mar
country: Chile
facility: Instituto Oncologico
city: Shanghai
country: China
facility: Ruiging Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: P.R. China
city: Beijing
country: China
facility: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: The Chinese PLA General Hospital
city: Tianjin
country: China
facility: The Hematology Hospital of Chinese Academy of Medical Science
city: Bogota
country: Colombia
facility: Fundacion Santa Fe de Bogota
state: Cundinamarca
city: Floridablanca
country: Colombia
facility: Fundacion Cardiovascular de Colombia
state: Santander
city: Bogota
country: Colombia
facility: CIOSAD Centro de Investigaciones Oncologicas
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: CHU Caen - Cote de Nacre
city: Le Chesnay Cedex
country: France
facility: Centre Hospitalier de Versailles Hopital Andre Mignot
city: Lyon
country: France
facility: Hopital EDOUARD HERRIOT
city: Nantes
country: France
facility: Hopital HOTEL DIEU
city: Nice Cedex 3
country: France
facility: Hospital Archet 1
city: Poitiers
country: France
facility: Centre d'Investigation Clinique- CIC INSERM802
city: Poitiers
country: France
facility: CHU de Poitiers
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg - Hopital Civil
city: Berlin
country: Germany
facility: Charite University Medical Center - Campus Virchow Klinikum
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Hamburg
country: Germany
facility: Univeristatsklinikum Hamburg-Eppendorf
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig Zentrum fur Innere Medizin
city: Mannheim
country: Germany
facility: III. Medizinische Klinik, Universitaetsklinikum Mannheim gGmbH
city: Muenchen
country: Germany
facility: III. Medizinischen Klinik und Poliklinik des Klinikums Rechts der Isar der TU-MUNCHEN
city: Shatin N.T.
country: Hong Kong
facility: Prince Of Wales Hospital
city: Budapest
country: Hungary
facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Kaposvar
country: Hungary
facility: Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Hospital
city: Mumbai
country: India
facility: Tata Memorial Center, Tata Memorial Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Advanced Centre for Treatment, Research and Education in Cancer
state: Maharashtra
city: Pune
country: India
facility: Jehangir Clinical Development Centre,
state: Maharashtra
city: Jaipur
country: India
facility: Birla Cancer Centre
state: Rajasthan
city: Jaipur
country: India
facility: SEAROC Cancer Center, Soni Manipal Hospital
state: Rajasthan
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
state: Lombardia
city: Orbassano
country: Italy
facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga
state: Torino
city: Catania
country: Italy
facility: Ospedale Ferrarotto - Divisione di Ematologia
city: Roma
country: Italy
facility: Dipartimento Di Ematologia Ospedale Santo Eugenio
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Akita City
country: Japan
facility: Akita University Hospital
state: Akita
city: Fukuoka-Shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Sendai
country: Japan
facility: Tohoku Univesity Hospital
state: Miyagi
city: Osakasayama
country: Japan
facility: Kinki University School Of Medicine
state: Osaka
city: Komae-shi
country: Japan
facility: Jikei University Hospital Daisan
state: Tokyo
city: Aichi
country: Japan
facility: Japanese Red Cross Nagoya First Hospital
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Shizuoka
country: Japan
facility: Hamamatsu Medical University Hospital Faculty of Medicine
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer & Infectious Disease Centre Komagome Hp
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital/Division of Hematology
city: Riga
country: Latvia
facility: Riga Centre Of Haematology
city: Vilnius
country: Lithuania
facility: Hematology, Oncology & Transfusion Medicine Center
city: Merida
country: Mexico
facility: Centro Medico de las Americas
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego
city: Krakow
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
city: Syktyvkar
country: Russian Federation
facility: GUZ Komi Republican Oncology Center
state: KOMI Republic
city: Barnaul
country: Russian Federation
facility: Regional State Budgetary Healthcare Institution "Barnaul City Hospital #8"
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital #1
city: Ekaterinburg
country: Russian Federation
facility: Central City Hospital #7
city: Kirov
country: Russian Federation
facility: Kirov Research Institute of Hematology and Blood Transfusion of
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution Hematology Scientific Center of Minzdravsotsrazvitiya of Russia
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Clinical Hospital
city: Perm
country: Russian Federation
facility: Perm Territory State Budgetary Healthcare Inst
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital na Baranov
city: Rostov-on-Don
country: Russian Federation
facility: Rostov Regional Clinical Hospital
city: Rostov-On-Don
country: Russian Federation
facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
city: Saint Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: St-Petersburg Pavlov's State Medical University
city: Saint Petersburg
country: Russian Federation
facility: St-Petersburg State Medical University
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital M.I. Kalinin
city: St. Petersburg
country: Russian Federation
facility: St-Petersburg Pavlov's State Medical University
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Johannesburg
country: South Africa
facility: University Witwatersrand and Oncology
city: Parktown
country: South Africa
facility: Johannesburg Hospital, Department of Medical Oncology
city: Soweto
country: South Africa
facility: Clinical Haematology Unit - Department of Medicine
city: Soweto
country: South Africa
facility: Department of Cardiology, Chris Hani Baragwanath Hospital
city: Soweto
country: South Africa
facility: Department of Radiology, Chris Hani Baragwanath Hospital
city: Barcelona
country: Spain
facility: Hospital Universitari Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital De La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital de Madrid Norte-Sanchinarro Centro Integral Oncologico
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo- Servicio de Hematologia.
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia (CHUV)
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Taipei TOC
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkoknoi
country: Thailand
facility: Division of Hematology, Department of Medicine
state: Bangkok
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
state: Sihhiye
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi
city: Cherkassy
country: Ukraine
facility: Cherkaskiy oblasniy onkologichniy dispanser
city: Dnipropetrovsk
country: Ukraine
facility: Clinical Assocation of Emergency Care
city: Dnipropetrovsk
country: Ukraine
facility: Clinical Diagnostic Laboratory of Komunalnyj Zaklad
city: Dnipropetrovsk
country: Ukraine
facility: Komunalnyj Zaklad "Dnipropetrovska Miska Bagatoprofilna Klinichna Likarnja #4"
city: Donetsk
country: Ukraine
facility: Instytut Nevidkladnoi ta Vidnovnoi Hirurgii im. P.K. Husaka NAMN Ukrainy, Viddilennja Hematologii
city: Kiev
country: Ukraine
facility: Oleksandrovska clinical hospital cardiological rehabilitation department
city: Kyev
country: Ukraine
facility: Miska klinichna likarnja # 9
city: Kyiv
country: Ukraine
facility: Institut Klinichnoi Radiologii DU "Natsionalnyj Naukovyj Centr Radiacijnoi Medicini NAMN Ukraini"
city: Kyiv
country: Ukraine
facility: Institut Klinichnoi Radiologii Naukovogo Centru Radiacijnoi Medicini NAMN Ukraini
city: Kyiv
country: Ukraine
facility: Institut Klinichnoi Radiologii Naukovogo
city: Lviv
country: Ukraine
facility: Ultrasaund Educational and Diagnostic Center
city: Lviv
country: Ukraine
facility: Instutut Patologii Krovi to Transfuziynoi Medicinu AMN Ukraini
city: Lviv
country: Ukraine
facility: Polyclinic of 5th Municipal Hospital
city: Nottingham
country: United Kingdom
facility: 3rd Floor Centre for Clinical Haematology
state: EAST Midlands
city: Nottingham
country: United Kingdom
facility: The Park Hospital
state: EAST Midlands
city: Hammersmith
country: United Kingdom
facility: Hammersmith Hospital Clinical Trial Units
state: London
city: Birmingham
country: United Kingdom
facility: Good Hope Hospital
state: WEST Midlands
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: WEST Midlands
city: Leeds
country: United Kingdom
facility: Department of Haematology - Level 3, Bexley Wing
state: WEST Yorkshire
city: London
country: United Kingdom
facility: Department of Haematology
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
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