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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Myeloid Leukemia
• Intervention / Treatment: Drug: Bosutinib; Drug: imatinib

• Study Type: Interventional
• Enrollment (Actual): 502
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1426
    • Instituto Médico Especializado Alexander Fleming
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, 1900
      • Hospital Italiano de La Plata
  • Prov. DE Cordoba
    • Cordoba, Prov. DE Cordoba, Argentina, 5000
      • Hospital Privado de Cordoba
  • Provincia Buenos Aires
    • Bahia Blanca, Provincia Buenos Aires, Argentina, B8000FJI
      • Centro de Investigaciones Oncologicas
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint Luc
  • Charleroi, Belgium, 6000
    • C.H.R.ST. - R. Fabiola (N-D)
  • Gent, Belgium, 9000
    • University Hospital Gent - Department of Hematology
  • La Louviere, Belgium, 7100
    • Centre Hospitalier de Jolimont - Lobbes
  • Lodelinsart, Belgium, 6042
    • CHU de Charleroi - Hopital Civil Marie Curie
  • Roeselare, Belgium, 8800
    • H.-Hartziekenhuis Roeselare-Menen
• Brazil
  • Campinas/ SP, Brazil, 6198
    • Centro De Hematologia E Hemoterapia Da Unicamp
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network, Princess Margaret Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hôpital Maisonneuve Rosemont
• Chile
  • Temuco, Chile
    • Instituto Oncologico del Sur
  • Vina del Mar, Chile
    • Instituto Oncologico
• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
  • Beijing, China, 100853
    • The Chinese PLA General Hospital
  • Tianjin, China, 300020
    • The Hematology Hospital of Chinese Academy of Medical Science
  • P.R. China
    • Shanghai, P.R. China, China, 200025
      • Ruiging Hospital Affiliated to Shanghai Jiaotong University School of Medicine
• Colombia
  • Bogota, Colombia
    • CIOSAD Centro de Investigaciones Oncologicas
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Fundacion Santa Fe de Bogota
  • Santander
    • Floridablanca, Santander, Colombia
      • Fundacion Cardiovascular de Colombia
• France
  • Bordeaux, France, 33076
    • Institut Bergonie
  • Caen, France, 14000
    • CHU Caen - Côte de Nacre
  • Le Chesnay Cedex, France, 78157
    • Centre Hospitalier de Versailles Hôpital Andre Mignot
  • Lyon, France, 69437
    • Hôpital Edouard Herriot
  • Nantes, France, 44000
    • Hôpital Hotel Dieu
  • Nice Cedex 3, France, 06202
    • Hospital Archet 1
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Poitiers, France, 86021
    • Centre d'Investigation Clinique- CIC INSERM802
  • Strasbourg, France, 67000
    • Clinique Sainte Anne
  • Strasbourg, France, 67098
    • Hopitaux Universitaires de Strasbourg - Hopital Civil
• Germany
  • Berlin, Germany, 13353
    • Charite University Medical Center - Campus Virchow Klinikum
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus
  • Hamburg, Germany, 20246
    • Univeristatsklinikum Hamburg-Eppendorf
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig Zentrum fur Innere Medizin
  • Mannheim, Germany, 68167
    • III. Medizinische Klinik, Universitaetsklinikum Mannheim gGmbH
  • Muenchen, Germany, 81675
    • III. Medizinischen Klinik und Poliklinik des Klinikums Rechts der Isar der TU-MUNCHEN
• Hong Kong
  • Shatin N.T., Hong Kong
    • Prince of Wales Hospital
• Hungary
  • Budapest, Hungary, 1097
    • Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
  • Gyor, Hungary, 9023
    • Petz Aladar Megyei Oktato Korhaz
  • Kaposvar, Hungary, 7400
    • Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
  • Nyiregyhaza, Hungary, 4400
    • Josa Andras Hospital
• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 012
      • Tata Memorial Center, Tata Memorial Hospital
    • Mumbai, Maharashtra, India, 410 210
      • Advanced Centre for Treatment, Research and Education in Cancer
    • Pune, Maharashtra, India, 411001
      • Jehangir Clinical Development Centre,
  • Rajasthan
    • Jaipur, Rajasthan, India, 302 004
      • Birla Cancer Centre
    • Jaipur, Rajasthan, India, 302013
      • SEAROC Cancer Center, Soni Manipal Hospital
• Italy
  • Catania, Italy, 95124
    • Ospedale Ferrarotto - Divisione di Ematologia
  • Roma, Italy, 00144
    • Dipartimento Di Ematologia Ospedale Santo Eugenio
  • Lombardia
    • Monza, Lombardia, Italy, 20900
      • Azienda Ospedaliera San Gerardo
  • Torino
    • Orbassano, Torino, Italy, 10043
      • Azienda Ospedaliera Universitaria San Luigi Gonzaga
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center Hospital
  • Aichi, Japan, 453-8511
    • Japanese Red Cross Nagoya First Hospital
  • Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Kanagawa, Japan, 259-1193
    • Tokai University Hospital
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Niigata, Japan, 9518520
    • Niigata University Medical And Dental Hospital
  • Osaka, Japan, 565-0871
    • Osaka University Hospital
  • Shizuoka, Japan, 4313192
    • Hamamatsu Medical University Hospital Faculty of Medicine
  • Tokyo, Japan, 113-8677
    • Tokyo Metropolitan Cancer & Infectious Disease Centre Komagome Hp
  • Aichi
    • Toyohashi, Aichi, Japan, 441-8570
      • Toyohashi Municipal Hospital
  • Akita
    • Akita City, Akita, Japan, 010-8543
      • Akita University Hospital
  • Fukuoka
    • Fukuoka-Shi, Fukuoka, Japan, 8111395
      • National Hospital Organization Kyushu Cancer Center
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 9808574
      • Tohoku Univesity Hospital
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
      • Kinki University School of Medicine
  • Tokyo
    • Komae-shi, Tokyo, Japan, 2018601
      • Jikei University Hospital Daisan
• Korea, Republic of
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea, Seoul St. Mary's Hospital/Division of Hematology
• Latvia
  • Riga, Latvia, 1006
    • Riga Centre Of Haematology
• Lithuania
  • Vilnius, Lithuania, LT-08661
    • Hematology, Oncology & Transfusion Medicine Center
• Mexico
  • Merida, Mexico, 97000
    • Centro Medico de las Américas
• Poland
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne
  • Katowice, Poland, 40-032
    • Samodzielny Publiczny Szpital Kliniczny Im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego
  • Krakow, Poland, 31-501
    • Sp Zoz Szpital Uniwersytecki W Krakowie
  • Lodz, Poland, 93-510
    • Wojewodzki Szpital Specjalistyczny im. M. Kopernika
  • Lublin, Poland, 20-081
    • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
• Russian Federation
  • Barnaul, Russian Federation, 656010
    • Regional State Budgetary Healthcare Institution "Barnaul City Hospital #8"
  • Ekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Clinical Hospital #1
  • Ekaterinburg, Russian Federation, 620137
    • Central City Hospital #7
  • Kirov, Russian Federation, 610027
    • Kirov Research Institute of Hematology and Blood Transfusion of
  • Moscow, Russian Federation, 125167
    • Federal State Budget Institution Hematology Scientific Center of Minzdravsotsrazvitiya of Russia
  • Novosibirsk, Russian Federation, 630087
    • State Novosibirsk Regional Clinical Hospital
  • Perm, Russian Federation, 614077
    • Perm Territory State Budgetary Healthcare Inst
  • Petrozavodsk, Russian Federation, 185019
    • Republican Hospital na Baranov
  • Rostov-On-Don, Russian Federation, 344022
    • Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
  • Rostov-on-Don, Russian Federation, 344015
    • Rostov Regional Clinical Hospital
  • Saint Petersburg, Russian Federation, 194291
    • Leningrad Regional Clinical Hospital
  • Saint Petersburg, Russian Federation, 197022
    • St-Petersburg Pavlov's State Medical University
  • Saint Petersburg, Russian Federation, 197022
    • St-Petersburg State Medical University
  • Samara, Russian Federation, 443095
    • Samara Regional Clinical Hospital M.I. Kalinin
  • St. Petersburg, Russian Federation, 197022
    • St-Petersburg Pavlov's State Medical University
  • Yaroslavl, Russian Federation, 150062
    • Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital
  • KOMI Republic
    • Syktyvkar, KOMI Republic, Russian Federation, 167904
      • GUZ Komi Republican Oncology Center
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
• South Africa
  • Johannesburg, South Africa, 2193
    • University Witwatersrand and Oncology
  • Parktown, South Africa, 2193
    • Johannesburg Hospital, Department of Medical Oncology
  • Soweto, South Africa, 2013
    • Clinical Haematology Unit - Department of Medicine
  • Soweto, South Africa, 2013
    • Department of Cardiology, Chris Hani Baragwanath Hospital
  • Soweto, South Africa, 2013
    • Department of Radiology, Chris Hani Baragwanath Hospital
• Spain
  • Barcelona, Spain, 08036
    • Hospital Universitari Clínic de Barcelona
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Hospital de La Princesa
  • Madrid, Spain, 28050
    • Hospital de Madrid Norte-Sanchinarro Centro Integral Oncologico
  • Toledo, Spain, 45004
    • Complejo Hospitalario de Toledo- Servicio de Hematologia.
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia (CHUV)
• Taiwan
  • Changhua City, Taiwan, 50006
    • Changhua Christian Hospital
  • Taipei TOC, Taiwan, 100
    • National Taiwan University Hospital
• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Division of Hematology, Department of Medicine
• Turkey
  • Ankara, Turkey, 06100
    • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
  • Gaziantep, Turkey, 27310
    • Gaziantep Universitesi Tip Fakultesi
  • Sihhiye
    • Ankara, Sihhiye, Turkey, 06100
      • Hacettepe Universitesi Tip Fakultesi
• Ukraine
  • Cherkassy, Ukraine, 18009
    • Cherkaskiy oblasniy onkologichniy dispanser
  • Dnipropetrovsk, Ukraine, 49006
    • Clinical Assocation of Emergency Care
  • Dnipropetrovsk, Ukraine, 49102
    • Clinical Diagnostic Laboratory of Komunalnyj Zaklad
  • Dnipropetrovsk, Ukraine, 49102
    • Komunalnyj Zaklad "Dnipropetrovska Miska Bagatoprofilna Klinichna Likarnja #4"
  • Donetsk, Ukraine, 83045
    • Instytut Nevidkladnoi ta Vidnovnoi Hirurgii im. P.K. Husaka NAMN Ukrainy, Viddilennja Hematologii
  • Kiev, Ukraine, 01023
    • Oleksandrovska clinical hospital cardiological rehabilitation department
  • Kyev, Ukraine, 04112
    • Miska klinichna likarnja # 9
  • Kyiv, Ukraine, 03115
    • Institut Klinichnoi Radiologii DU "Natsionalnyj Naukovyj Centr Radiacijnoi Medicini NAMN Ukraini"
  • Kyiv, Ukraine, 03115
    • Institut Klinichnoi Radiologii Naukovogo Centru Radiacijnoi Medicini NAMN Ukraini
  • Kyiv, Ukraine, 03115
    • Institut Klinichnoi Radiologii Naukovogo
  • Lviv, Ukraine, 79010
    • Ultrasaund Educational and Diagnostic Center
  • Lviv, Ukraine, 79044
    • Instutut Patologii Krovi to Transfuziynoi Medicinu AMN Ukraini
  • Lviv, Ukraine, 79044
    • Polyclinic of 5th Municipal Hospital
• United Kingdom
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital
  • London, United Kingdom, SE1 9RT
    • Department of Haematology
  • EAST Midlands
    • Nottingham, EAST Midlands, United Kingdom, NG5 1PB
      • 3rd Floor Centre for Clinical Haematology
    • Nottingham, EAST Midlands, United Kingdom, NG5 8RX
      • The Park Hospital
  • London
    • Hammersmith, London, United Kingdom, W12 0HS
      • Hammersmith Hospital Clinical Trial Units
  • WEST Midlands
    • Birmingham, WEST Midlands, United Kingdom, B75 7RR
      • Good Hope Hospital
    • Birmingham, WEST Midlands, United Kingdom, B9 5SS
      • Birmingham Heartlands Hospital
  • WEST Yorkshire
    • Leeds, WEST Yorkshire, United Kingdom, LS9 7TF
      • Department of Haematology - Level 3, Bexley Wing
• United States
  • California
    • Anaheim, California, United States, 92801
      • Pacific Cancer Medical Center Inc
    • Beverly Hills, California, United States, 90211-1848
      • Tower Cancer Research Foundation (TCRF)
    • Fountain Valley, California, United States, 92708
      • Robert A Moss, MD, FACP, Inc
    • La Jolla, California, United States, 92093
      • UCSD Moores Cancer Center
    • La Jolla, California, United States, 92037
      • UCSD Medical Center-Thornton
    • San Diego, California, United States, 92103
      • UCSD Medical Center-Hillcrest
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
    • Stanford, California, United States, 94305
      • Stanford Hospitals and Clinics
    • Stanford, California, United States, 94305
      • Stanford Hospital and Clinics Investigational Drug Services
  • Florida
    • Hudson, Florida, United States, 34667
      • Cancer Care Centers of Florida
    • New Port Richey, Florida, United States, 34652
      • Pasco Pinellas Cancer Center
    • New Port Richey, Florida, United States, 34652
      • Cancer Care Centers of Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc.
    • Tarpon Springs, Florida, United States, 34689
      • Pasco Pinellas Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30341
      • Northside Hospital, Inc. - GCS/Annex
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indiana Blood and Marrow Transplantation Research
    • Indianapolis, Indiana, United States, 46237
      • Indiana Blood and Marrow Transplantation Research Franciscan St. Francis Health Center Inc.
  • Iowa
    • Sioux City, Iowa, United States, 51101
      • Siouxland Hematology-Oncology Associates, LLP
  • Kansas
    • Salinas, Kansas, United States, 67401
      • Cancer Center of Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Kentucky
    • Hazard, Kentucky, United States, 41701-9466
      • Kentucky Cancer Clinic
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders
  • Michigan
    • Brownstown, Michigan, United States, 48183
      • Josephine Ford Cancer - Downriver
    • Dearborn, Michigan, United States, 48126
      • Henry Ford Medical Center- Fairlane
    • Detroit, Michigan, United States, 48202-2689
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48322
      • Henry Ford Hospital - West Bloomfield
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • Regional Cancer Care Associates
    • Cherry Hill, New Jersey, United States, 08003
      • Study Supplies: Regional Cancer Care Associates
    • Somerville, New Jersey, United States, 08876
      • Somerset Hematology Oncology Associates
  • New Mexico
    • Farmington, New Mexico, United States, 87401
      • San Juan Oncology Associates
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Associates in Oncology and Hematology
  • Texas
    • Houston, Texas, United States, 77030-4009
      • The University of Texas M.D. Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Bosutinib	Drug: 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.; Other Names: SKI 606
Active Comparator: 2; Imatinib	Drug: 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 Names: Gleevec

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Major Molecular Response (MMR) at Year 1	Molecular response was assessed using Bcr-Abl transcript levels measured by reverse transcriptase polymerase chain reaction (RT-PCR) from peripheral blood. A MMR was defined as a ratio Bcr-Abl/Abl less than or equal to (≤) 0.1% on the international scale (greater than or equal to [≥] 3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed.	Year 1 (48 weeks)
Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks	The Kaplan-Meier curve was generated based the time from the first date of CCyR until the first date of confirmed loss of CCyR, objectively documented, for responders only. Participants without confirmed loss of CCyR were censored at the last valid cytogenetic assessment. CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or <1% Bcr-Abl fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed. The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CCyR by Year 1.	192 weeks
Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks	The Kaplan-Meier curve was generated based on the first date of confirmed CHR until the first date of loss of CHR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid hematologic assessment. CHR must have been of at least 4 weeks in duration confirmed by 2 assessments at least 4 weeks apart and was defined as follows: white blood cells ≤ institutional upper limit of normal, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, absolute neutrophil count ≥1.0*10^9/L, platelets ≥100 but <450*10^9/L unless related to therapy, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly). The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CHR by Year 1.	192 weeks
Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks	The Kaplan-Meier curve was generated based on the first date of MMR until the first date loss of MMR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid molecular assessment. Molecular response was assessed using Bcr-Abl transcript levels measured by RT-PCR from peripheral blood. MMR is defined as a ratio Bcr-Abl/Abl ≤0.1% on the international scale (≥3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed. The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Three years rate was displayed since the majority of imatinib participants had first MMR by Year 2.	144 weeks
Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks	The cumulative incidence curve was generated based on the time from randomization to the first date of transformation to AP or BP while on study treatment adjusting for the competing risk of treatment discontinuation without transformation, for each participant. Criteria for transformation to AP: 15 to 29% blasts; ≥30% blasts + promyelocytes; ≥20% basophils in blood or bone marrow; platelets <100*10^9/L (not related to therapy), in blood. Criteria for transformation to BP: ≥30% blasts in blood or bone marrow and extramedullary involvement other than liver or spleen (example: chloromas). Time to transformation was calculated as weeks = ([date of first documented occurrence of the event - date of randomization] + 1)/7. If transformation was not obtained, censoring was at the last hematologic assessment or death (whichever was earliest). Participants who were not treated contributed time = 1 day/7. 95% confidence interval for the cumulative incidence is from Gray's method.	192 weeks

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Nat Rev Cancer. 2012 Dec;12(12):886.
• 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.
• 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.
• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2008
• Primary Completion (Actual): August 31, 2010
• Study Completion (Actual): May 27, 2015

Study Registration Dates

• First Submitted: December 13, 2007
• First Submitted That Met QC Criteria: December 14, 2007
• First Posted (Estimate): December 17, 2007

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: CML; Bosutinib; imatinib
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Chromosome Aberrations; Translocation, Genetic; Leukemia, Myeloid; Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: 3160A4-3000; B1871008 (Other Identifier: Alias Study Number); 2007-003780-50 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.