Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA
3 other identifiers
interventional
502
29 countries
165
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2008
Longer than P75 for phase_3
165 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2007
CompletedFirst Posted
Study publicly available on registry
December 17, 2007
CompletedStudy Start
First participant enrolled
February 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2010
CompletedResults Posted
Study results publicly available
November 5, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2015
CompletedJanuary 8, 2019
December 1, 2018
2.6 years
December 13, 2007
October 4, 2012
December 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1
Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0 percent (%) Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or less than (\<) 1% breakpoint cluster region Abelson protooncogene (Bcr-Abl) fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.
Year 1 (48 weeks)
Secondary Outcomes (5)
Percentage of Participants With Major Molecular Response (MMR) at Year 1
Year 1 (48 weeks)
Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks
192 weeks
Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks
192 weeks
Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks
144 weeks
Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks
192 weeks
Study Arms (2)
1
EXPERIMENTALBosutinib
2
ACTIVE COMPARATORImatinib
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior anti-leukemia treatment.
- Prior stem cell transplant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
Study Sites (165)
Pacific Cancer Medical Center Inc
Anaheim, California, 92801, United States
Tower Cancer Research Foundation (TCRF)
Beverly Hills, California, 90211-1848, 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, 41701-9466, 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, 48202-2689, 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, 77030-4009, United States
Hospital Italiano de la Plata
La Plata, Buenos Aires, 1900, Argentina
Hospital Privado de Cordoba
CĂ³rdoba, Prov. de Cordoba, 5000, Argentina
Centro de Investigaciones Oncologicas
BahĂa Blanca, Provincia Buenos Aires, B8000FJI, 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
Ghent, 9000, Belgium
Centre Hospitalier de Jolimont - Lobbes
La Louvière, 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 1M9, Canada
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, 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, 200025, China
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, 100730, China
The Chinese PLA General Hospital
Beijing, 100853, China
The Hematology Hospital of Chinese Academy of Medical Science
Tianjin, 300020, China
Fundacion Santa Fe de Bogota
Bogota, Cundinamarca, Colombia
Fundacion Cardiovascular de Colombia
Floridablanca, Santander Department, Colombia
CIOSAD Centro de Investigaciones Oncologicas
BogotĂ¡, Colombia
Institut Bergonie
Bordeaux, 33076, France
CHU Caen - Cote de Nacre
Caen, 14000, France
Centre Hospitalier de Versailles Hopital Andre Mignot
Le Chesnay, 78157, France
Hopital EDOUARD HERRIOT
Lyon, 69437, France
Hopital HOTEL DIEU
Nantes, 44000, France
Hospital Archet 1
Nice, 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
MĂ¼nchen, 81675, Germany
Prince Of Wales Hospital
Shatin N.T., HONG KONG, Hong Kong
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
Budapest, 1097, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9023, Hungary
Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
KaposvĂ¡r, 7400, Hungary
Josa Andras Hospital
NyĂregyhĂ¡za, 4400, Hungary
Tata Memorial Center, Tata Memorial Hospital
Mumbai, Maharashtra, 400 012, India
Advanced Centre for Treatment, Research and Education in Cancer
Mumbai, Maharashtra, 410 210, India
Jehangir Clinical Development Centre,
Pune, Maharashtra, 411001, India
Birla Cancer Centre
Jaipur, Rajasthan, 302 004, India
SEAROC Cancer Center, Soni Manipal Hospital
Jaipur, Rajasthan, 302013, India
Azienda Ospedaliera San Gerardo
Monza, Lombardy, 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-ken, 441-8570, Japan
Akita University Hospital
Akita, Akita, 010-8543, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 8111395, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Tohoku Univesity Hospital
Sendai, Miyagi, 9808574, Japan
Kinki University School Of Medicine
Sayama, Osaka, 589-8511, Japan
Jikei University Hospital Daisan
Komae-shi, Tokyo, 2018601, Japan
Japanese Red Cross Nagoya First Hospital
Aichi, 453-8511, Japan
Aichi Cancer Center Hospital
Aichi, 464-8681, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Niigata University Medical and Dental Hospital
Niigata, 9518520, Japan
Osaka University Hospital
Osaka, 565-0871, Japan
Hamamatsu Medical University Hospital Faculty of Medicine
Shizuoka, 4313192, Japan
Tokyo Metropolitan Cancer & Infectious Disease Centre Komagome Hp
Tokyo, 113-8677, Japan
Riga Centre Of Haematology
Riga, 1006, Latvia
Hematology, Oncology & Transfusion Medicine Center
Vilnius, LT-08661, Lithuania
Centro Medico de las Americas
MĂ©rida, 97000, Mexico
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Samodzielny Publiczny Szpital Kliniczny Im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego
Katowice, 40-032, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-501, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, 93-510, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, 20-081, Poland
GUZ Komi Republican Oncology Center
Syktyvkar, Komi, 167904, Russia
Regional State Budgetary Healthcare Institution "Barnaul City Hospital #8"
Barnaul, 656010, Russia
Kirov Research Institute of Hematology and Blood Transfusion of
Kirov, 610027, Russia
Federal State Budget Institution Hematology Scientific Center of Minzdravsotsrazvitiya of Russia
Moscow, 125167, Russia
State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087, Russia
Perm Territory State Budgetary Healthcare Inst
Perm, 614077, Russia
Republican Hospital na Baranov
Petrozavodsk, 185019, Russia
Rostov Regional Clinical Hospital
Rostov-on-Don, 344015, Russia
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
Rostov-on-Don, 344022, Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291, Russia
St-Petersburg Pavlov's State Medical University
Saint Petersburg, 197022, Russia
St-Petersburg State Medical University
Saint Petersburg, 197022, Russia
Samara Regional Clinical Hospital M.I. Kalinin
Samara, 443095, Russia
Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital
Yaroslavl, 150062, Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, 620102, Russia
Central City Hospital #7
Yekaterinburg, 620137, Russia
Singapore General Hospital
Singapore, 169608, 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
The Catholic University of Korea, Seoul St. Mary's Hospital/Division of Hematology
Seoul, 137-701, South Korea
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, 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 (TĂ¼rkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara, 06100, Turkey (TĂ¼rkiye)
Gaziantep Universitesi Tip Fakultesi
Gaziantep, 27310, Turkey (TĂ¼rkiye)
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
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
Miska klinichna likarnja # 9
Kyiv, 04112, 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 1PB, United Kingdom
The Park Hospital
Nottingham, EAST Midlands, NG5 8RX, United Kingdom
Hammersmith Hospital Clinical Trial Units
Hammersmith, London, W12 0HS, United Kingdom
Good Hope Hospital
Birmingham, WEST Midlands, B75 7RR, United Kingdom
Birmingham Heartlands Hospital
Birmingham, WEST Midlands, B9 5SS, United Kingdom
Department of Haematology - Level 3, Bexley Wing
Leeds, WEST Yorkshire, LS9 7TF, United Kingdom
Department of Haematology
London, SE1 9RT, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
Related Publications (7)
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.
PMID: 37553873DERIVEDTakahashi 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.
PMID: 35235189DERIVEDGambacorti-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.
PMID: 24944159DERIVEDHsyu 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.
PMID: 24919837DERIVEDTrask 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.
PMID: 23116602DERIVEDCortes 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.
PMID: 22949154DERIVEDO'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.
PMID: 22825216DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2007
First Posted
December 17, 2007
Study Start
February 5, 2008
Primary Completion
August 31, 2010
Study Completion
May 27, 2015
Last Updated
January 8, 2019
Results First Posted
November 5, 2012
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.