Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
NCT ID: NCT00574873
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
502 participants
INTERVENTIONAL
2008-02-05
2015-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Bosutinib
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.
2
Imatinib
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of CML chronic phase confirmed.
* Adequate hepatic and renal function.
* Able to take oral tablets.
Exclusion Criteria
* Prior anti-leukemia treatment.
* Prior stem cell transplant.
18 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Córdoba, Prov. de Cordoba, Argentina
Centro de Investigaciones Oncologicas
Bahía 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
Ghent, , Belgium
Centre Hospitalier de Jolimont - Lobbes
La Louvière, , 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
Viña 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 Department, Colombia
CIOSAD Centro de Investigaciones Oncologicas
Bogotá, , Colombia
Institut Bergonie
Bordeaux, , France
CHU Caen - Cote de Nacre
Caen, , France
Centre Hospitalier de Versailles Hopital Andre Mignot
Le Chesnay, , France
Hopital EDOUARD HERRIOT
Lyon, , France
Hopital HOTEL DIEU
Nantes, , France
Hospital Archet 1
Nice, , 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
München, , Germany
Prince Of Wales Hospital
Shatin N.T., HONG KONG, Hong Kong
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
Budapest, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
Kaposvár, , Hungary
Josa Andras Hospital
Nyíregyháza, , 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, Lombardy, 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-ken, Japan
Akita University Hospital
Akita, Akita, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Tohoku Univesity Hospital
Sendai, Miyagi, Japan
Kinki University School Of Medicine
Sayama, 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
Riga Centre Of Haematology
Riga, , Latvia
Hematology, Oncology & Transfusion Medicine Center
Vilnius, , Lithuania
Centro Medico de las Americas
Mérida, , 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, Russia
Regional State Budgetary Healthcare Institution "Barnaul City Hospital #8"
Barnaul, , Russia
Kirov Research Institute of Hematology and Blood Transfusion of
Kirov, , Russia
Federal State Budget Institution Hematology Scientific Center of Minzdravsotsrazvitiya of Russia
Moscow, , Russia
State Novosibirsk Regional Clinical Hospital
Novosibirsk, , Russia
Perm Territory State Budgetary Healthcare Inst
Perm, , Russia
Republican Hospital na Baranov
Petrozavodsk, , Russia
Rostov Regional Clinical Hospital
Rostov-on-Don, , Russia
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
Rostov-on-Don, , Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
St-Petersburg Pavlov's State Medical University
Saint Petersburg, , Russia
St-Petersburg State Medical University
Saint Petersburg, , Russia
Samara Regional Clinical Hospital M.I. Kalinin
Samara, , Russia
Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital
Yaroslavl, , Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, , Russia
Central City Hospital #7
Yekaterinburg, , Russia
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
The Catholic University of Korea, Seoul St. Mary's Hospital/Division of Hematology
Seoul, , South Korea
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, , Taiwan
National Taiwan University Hospital
Taipei TOC, , Taiwan
Division of Hematology, Department of Medicine
Bangkoknoi, Bangkok, Thailand
Hacettepe Universitesi Tip Fakultesi
Ankara, Sihhiye, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara, , Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi
Gaziantep, , Turkey (Türkiye)
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
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
Miska klinichna likarnja # 9
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
Countries
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References
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Garrett M, Knight B, Cortes JE, Deininger MW. Population modeling of bosutinib exposure-response in patients with newly diagnosed chronic phase chronic myeloid leukemia. Cancer Med. 2023 Sep;12(17):17981-17992. doi: 10.1002/cam4.6439. Epub 2023 Aug 8.
Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.
Gambacorti-Passerini C, Cortes JE, Lipton JH, Dmoszynska A, Wong RS, Rossiev V, Pavlov D, Gogat Marchant K, Duvillie L, Khattry N, Kantarjian HM, Brummendorf TH. Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia. Am J Hematol. 2014 Oct;89(10):947-53. doi: 10.1002/ajh.23788. Epub 2014 Jul 21.
Hsyu PH, Mould DR, Abbas R, Amantea M. Population pharmacokinetic and pharmacodynamic analysis of bosutinib. Drug Metab Pharmacokinet. 2014;29(6):441-8. doi: 10.2133/dmpk.DMPK-13-RG-126. Epub 2014 Jun 10.
Trask PC, Cella D, Powell C, Reisman A, Whiteley J, Kelly V. Health-related quality of life in chronic myeloid leukemia. Leuk Res. 2013 Jan;37(1):9-13. doi: 10.1016/j.leukres.2012.09.013. Epub 2012 Oct 29.
Cortes JE, Kim DW, Kantarjian HM, Brummendorf TH, Dyagil I, Griskevicius L, Malhotra H, Powell C, Gogat K, Countouriotis AM, Gambacorti-Passerini C. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the BELA trial. J Clin Oncol. 2012 Oct 1;30(28):3486-92. doi: 10.1200/JCO.2011.38.7522. Epub 2012 Sep 4.
O'Hare T, Zabriskie MS, Eiring AM, Deininger MW. Pushing the limits of targeted therapy in chronic myeloid leukaemia. Nat Rev Cancer. 2012 Jul 24;12(8):513-26. doi: 10.1038/nrc3317.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1871008
Identifier Type: OTHER
Identifier Source: secondary_id
2007-003780-50
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3160A4-3000
Identifier Type: -
Identifier Source: org_study_id
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