AzTrials
AzTrials

Chronic Myeloid LeukemiaPhase 3NCT00574873

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

A Phase 3 study testing Bosutinib and imatinib in people with Chronic Myeloid Leukemia, run by Pfizer at 165 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
Bosutinib and imatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
502 participants
Where
165 sitesin 29 countries
Study dates
5 Feb 2008to 27 May 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

165 sites in 29 countries.

165 sites in 29 countries

United States32 sites

  • Pacific Cancer Medical Center Inc

    Anaheim, California, 92801

  • Northside Hospital, Inc. - GCS/Annex

    Atlanta, Georgia, 30341

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Tower Cancer Research Foundation (TCRF)

    Beverly Hills, California, 90211-1848

  • Josephine Ford Cancer - Downriver

    Brownstown, Michigan, 48183

  • Associates In Oncology and Hematology

    Chattanooga, Tennessee, 37421

  • Regional Cancer Care Associates

    Cherry Hill, New Jersey, 08003

  • Study Supplies: Regional Cancer Care Associates

    Cherry Hill, New Jersey, 08003

  • Henry Ford Medical Center- Fairlane

    Dearborn, Michigan, 48126

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689

  • Henry Ford Hospital - West Bloomfield

    Detroit, Michigan, 48322

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Robert A Moss, MD, FACP, Inc

    Fountain Valley, California, 92708

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701-9466

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Cancer Care Centers of Florida

    Hudson, Florida, 34667

  • Indiana Blood and Marrow Transplantation Research Franciscan St. Francis Health Center Inc.

    Indianapolis, Indiana, 46237

  • Indiana Blood and Marrow Transplantation Research

    Indianapolis, Indiana, 46237

  • UCSD Medical Center-Thornton

    La Jolla, California, 92037

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

  • Cancer Care Centers of Florida

    New Port Richey, Florida, 34652

  • Pasco Pinellas Cancer Center

    New Port Richey, Florida, 34652

  • Orlando Health, Inc.

    Orlando, Florida, 32806

  • Cancer Center of Kansas

    Salinas, Kansas, 67401

  • UCSD Medical Center-Hillcrest

    San Diego, California, 92103

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Somerset Hematology Oncology Associates

    Somerville, New Jersey, 08876

  • Stanford Hospital and Clinics Investigational Drug Services

    Stanford, California, 94305

  • Stanford Hospitals and Clinics

    Stanford, California, 94305

  • Stanford University Medical Center

    Stanford, California, 94305

  • Pasco Pinellas Cancer Center

    Tarpon Springs, Florida, 34689

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

Japan16 sites

  • Japanese Red Cross Nagoya First Hospital

    Aichi, 453-8511

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • Akita University Hospital

    Akita, Akita, 010-8543

  • Chiba University Hospital

    Chiba, 260-8677

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 8111395

  • Tokai University Hospital

    Kanagawa, 259-1193

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Jikei University Hospital Daisan

    Komae-shi, Tokyo, 2018601

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Niigata University Medical and Dental Hospital

    Niigata, 9518520

  • Osaka University Hospital

    Osaka, 565-0871

  • Kinki University School Of Medicine

    Sayama, Osaka, 589-8511

  • Tohoku Univesity Hospital

    Sendai, Miyagi, 9808574

  • Hamamatsu Medical University Hospital Faculty of Medicine

    Shizuoka, 4313192

  • Tokyo Metropolitan Cancer & Infectious Disease Centre Komagome Hp

    Tokyo, 113-8677

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

Other trials in Japan

Russia16 sites

  • Regional State Budgetary Healthcare Institution "Barnaul City Hospital #8"

    Barnaul, 656010

  • Kirov Research Institute of Hematology and Blood Transfusion of

    Kirov, 610027

  • Federal State Budget Institution Hematology Scientific Center of Minzdravsotsrazvitiya of Russia

    Moscow, 125167

  • State Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630087

  • Perm Territory State Budgetary Healthcare Inst

    Perm, 614077

  • Republican Hospital na Baranov

    Petrozavodsk, 185019

  • Rostov Regional Clinical Hospital

    Rostov-on-Don, 344015

  • Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

    Rostov-on-Don, 344022

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • St-Petersburg Pavlov's State Medical University

    Saint Petersburg, 197022

  • St-Petersburg State Medical University

    Saint Petersburg, 197022

  • Samara Regional Clinical Hospital M.I. Kalinin

    Samara, 443095

  • GUZ Komi Republican Oncology Center

    Syktyvkar, Komi, 167904

  • Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital

    Yaroslavl, 150062

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

  • Central City Hospital #7

    Yekaterinburg, 620137

Other trials in Russia

Ukraine13 sites

  • Cherkaskiy oblasniy onkologichniy dispanser

    Cherkassy, 18009

  • Clinical Assocation of Emergency Care

    Dnipropetrovsk, 49006

  • Clinical Diagnostic Laboratory of Komunalnyj Zaklad

    Dnipropetrovsk, 49102

  • Komunalnyj Zaklad "Dnipropetrovska Miska Bagatoprofilna Klinichna Likarnja #4"

    Dnipropetrovsk, 49102

  • Instytut Nevidkladnoi ta Vidnovnoi Hirurgii im. P.K. Husaka NAMN Ukrainy, Viddilennja Hematologii

    Donetsk, 83045

  • Oleksandrovska clinical hospital cardiological rehabilitation department

    Kiev, 01023

  • Institut Klinichnoi Radiologii DU "Natsionalnyj Naukovyj Centr Radiacijnoi Medicini NAMN Ukraini"

    Kyiv, 03115

  • Institut Klinichnoi Radiologii Naukovogo Centru Radiacijnoi Medicini NAMN Ukraini

    Kyiv, 03115

  • Institut Klinichnoi Radiologii Naukovogo

    Kyiv, 03115

  • Miska klinichna likarnja # 9

    Kyiv, 04112

  • Ultrasaund Educational and Diagnostic Center

    Lviv, 79010

  • Instutut Patologii Krovi to Transfuziynoi Medicinu AMN Ukraini

    Lviv, 79044

  • Polyclinic of 5th Municipal Hospital

    Lviv, 79044

Other trials in Ukraine

France10 sites

  • Institut Bergonie

    Bordeaux, 33076

  • CHU Caen - Cote de Nacre

    Caen, 14000

  • Centre Hospitalier de Versailles Hopital Andre Mignot

    Le Chesnay, 78157

  • Hopital EDOUARD HERRIOT

    Lyon, 69437

  • Hopital HOTEL DIEU

    Nantes, 44000

  • Hospital Archet 1

    Nice, 06202

  • Centre d'Investigation Clinique- CIC INSERM802

    Poitiers, 86021

  • CHU de Poitiers

    Poitiers, 86021

  • Clinique Sainte Anne

    Strasbourg, 67000

  • Hopitaux Universitaires de Strasbourg - Hopital Civil

    Strasbourg, 67098

Other trials in France

United Kingdom8 sites

  • Good Hope Hospital

    Birmingham, WEST Midlands, B75 7RR

  • Birmingham Heartlands Hospital

    Birmingham, WEST Midlands, B9 5SS

  • Hammersmith Hospital Clinical Trial Units

    Hammersmith, London, W12 0HS

  • Department of Haematology - Level 3, Bexley Wing

    Leeds, WEST Yorkshire, LS9 7TF

  • Department of Haematology

    London, SE1 9RT

  • Hammersmith Hospital

    London, W12 0HS

  • 3rd Floor Centre for Clinical Haematology

    Nottingham, EAST Midlands, NG5 1PB

  • The Park Hospital

    Nottingham, EAST Midlands, NG5 8RX

Other trials in United Kingdom

Belgium6 sites

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • C.H.R.ST. - R. Fabiola (N-D)

    Charleroi, 6000

  • University Hospital Gent - Department of Hematology

    Ghent, 9000

  • Centre Hospitalier de Jolimont - Lobbes

    La Louvière, 7100

  • CHU de Charleroi - Hopital civil Marie Curie

    Lodelinsart, 6042

  • H.-Hartziekenhuis Roeselare-Menen

    Roeselare, 8800

Other trials in Belgium

Germany6 sites

  • Charite University Medical Center - Campus Virchow Klinikum

    Berlin, 13353

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • Univeristatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitaetsklinikum Leipzig Zentrum fur Innere Medizin

    Leipzig, 04103

  • III. Medizinische Klinik, Universitaetsklinikum Mannheim gGmbH

    Mannheim, 68167

  • III. Medizinischen Klinik und Poliklinik des Klinikums Rechts der Isar der TU-MUNCHEN

    München, 81675

Other trials in Germany

Spain6 sites

  • Hospital Universitari Clinic de Barcelona

    Barcelona, 08036

  • Hospital De La Princesa

    Madrid, 28006

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital de Madrid Norte-Sanchinarro Centro Integral Oncologico

    Madrid, 28050

  • Complejo Hospitalario de Toledo- Servicio de Hematologia.

    Toledo, 45004

  • Hospital Clinico Universitario de Valencia (CHUV)

    Valencia, 46010

Other trials in Spain

India5 sites

  • Birla Cancer Centre

    Jaipur, Rajasthan, 302 004

  • SEAROC Cancer Center, Soni Manipal Hospital

    Jaipur, Rajasthan, 302013

  • Tata Memorial Center, Tata Memorial Hospital

    Mumbai, Maharashtra, 400 012

  • Advanced Centre for Treatment, Research and Education in Cancer

    Mumbai, Maharashtra, 410 210

  • Jehangir Clinical Development Centre,

    Pune, Maharashtra, 411001

Other trials in India

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Samodzielny Publiczny Szpital Kliniczny Im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego

    Katowice, 40-032

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika

    Lodz, 93-510

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

    Lublin, 20-081

Other trials in Poland

South Africa5 sites

  • University Witwatersrand and Oncology

    Johannesburg, 2193

  • Johannesburg Hospital, Department of Medical Oncology

    Parktown, 2193

  • Clinical Haematology Unit - Department of Medicine

    Soweto, 2013

  • Department of Cardiology, Chris Hani Baragwanath Hospital

    Soweto, 2013

  • Department of Radiology, Chris Hani Baragwanath Hospital

    Soweto, 2013

Other trials in South Africa

Argentina4 sites

  • Centro de Investigaciones Oncologicas

    Bahía Blanca, Provincia Buenos Aires, B8000FJI

  • Instituto Medico Especializado Alexander Fleming

    Buenos Aires, 1426

  • Hospital Privado de Cordoba

    Córdoba, Prov. de Cordoba, 5000

  • Hospital Italiano de la Plata

    La Plata, Buenos Aires, 1900

Other trials in Argentina

China4 sites

  • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

    Beijing, 100730

  • The Chinese PLA General Hospital

    Beijing, 100853

  • Ruiging Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, P.R. China, 200025

  • The Hematology Hospital of Chinese Academy of Medical Science

    Tianjin, 300020

Other trials in China

Hungary4 sites

  • Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet

    Budapest, 1097

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9023

  • Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly

    Kaposvár, 7400

  • Josa Andras Hospital

    Nyíregyháza, 4400

Other trials in Hungary

Italy4 sites

  • Ospedale Ferrarotto - Divisione di Ematologia

    Catania, 95124

  • Azienda Ospedaliera San Gerardo

    Monza, Lombardy, 20900

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano, Torino, 10043

  • Dipartimento Di Ematologia Ospedale Santo Eugenio

    Roma, 00144

Other trials in Italy

Canada3 sites

  • Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • University Health Network, Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Colombia3 sites

  • Fundacion Santa Fe de Bogota

    Bogota, Cundinamarca

  • CIOSAD Centro de Investigaciones Oncologicas

    Bogotá

  • Fundacion Cardiovascular de Colombia

    Floridablanca, Santander Department

Other trials in Colombia

Turkey (Türkiye)3 sites

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, Sihhiye, 06100

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

    Ankara, 06100

  • Gaziantep Universitesi Tip Fakultesi

    Gaziantep, 27310

Other trials in Turkey (Türkiye)

Chile2 sites

  • Instituto Oncologico del Sur

    Temuco

  • Instituto Oncologico

    Viña del Mar

Other trials in Chile

Taiwan2 sites

  • Changhua Christian Hospital

    Changhua, 50006

  • National Taiwan University Hospital

    Taipei TOC, 100

Other trials in Taiwan

Brazil1 site

  • Centro De Hematologia E Hemoterapia Da Unicamp

    Campinas/ SP, 6198

Other trials in Brazil

Hong Kong1 site

  • Prince Of Wales Hospital

    Shatin N.T., HONG KONG

Other trials in Hong Kong

Latvia1 site

  • Riga Centre Of Haematology

    Riga, 1006

Other trials in Latvia

Lithuania1 site

  • Hematology, Oncology & Transfusion Medicine Center

    Vilnius, LT-08661

Other trials in Lithuania

Mexico1 site

  • Centro Medico de las Americas

    Mérida, 97000

Other trials in Mexico

Singapore1 site

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

South Korea1 site

  • The Catholic University of Korea, Seoul St. Mary's Hospital/Division of Hematology

    Seoul, 137-701

Other trials in South Korea

Thailand1 site

  • Division of Hematology, Department of Medicine

    Bangkoknoi, Bangkok, 10700

Other trials in Thailand

About this study

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

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.

Being tested
Bosutinib, imatinib
Keywords
Bosutinib, imatinib, CML
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BosutinibDrug

    Also called SKI 606

    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.

  • imatinibDrug

    Also called Gleevec

    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.

Study groups in NCT00574873
Study groupRoleWhat they receive
1ExperimentalBosutinib
Receives: Drug: Bosutinib
2Active comparatorImatinib
Receives: Drug: imatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Year 1 (48 weeks)

Secondary outcomes (5)

  1. 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.

    Measured: Year 1 (48 weeks)

  2. 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.

    Measured: 192 weeks

  3. 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.

    Measured: 192 weeks

  4. 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.

    Measured: 144 weeks

  5. 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.

    Measured: 192 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2007 (estimated)
  2. Study start5 Feb 2008
  3. Primary completion31 Aug 2010
  4. Study completion27 May 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00574873
Sponsor's protocol ID
3160A4-3000
Other IDs
B1871008, 2007-003780-50
Status last verified
Dec 2018
First submitted
13 Dec 2007
Last updated
8 Jan 2019
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37553873

  • 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.

    PubMed 35235189

  • 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.

    PubMed 24944159

  • 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.

    PubMed 24919837

  • 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.

    PubMed 23116602

  • 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.

    PubMed 22949154

  • 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.

    PubMed 22825216

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bosutinib and imatinib in people with Chronic Myeloid Leukemia, run by Pfizer at 165 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States, Japan, Russia, Ukraine, France and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1 (time frame: Year 1 (48 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00574873, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.

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