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

Primary Purpose

Chronic Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bosutinib
imatinib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring Bosutinib, imatinib, CML

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pacific Cancer Medical Center Inc
  • Tower Cancer Research Foundation (TCRF)
  • Robert A Moss, MD, FACP, Inc
  • UCSD Medical Center-Thornton
  • UCSD Moores Cancer Center
  • UCSD Medical Center-Hillcrest
  • Stanford Hospital and Clinics Investigational Drug Services
  • Stanford Hospitals and Clinics
  • Stanford University Medical Center
  • Cancer Care Centers of Florida
  • Cancer Care Centers of Florida
  • Pasco Pinellas Cancer Center
  • Orlando Health, Inc.
  • Pasco Pinellas Cancer Center
  • Northside Hospital, Inc. - GCS/Annex
  • Indiana Blood and Marrow Transplantation Research Franciscan St. Francis Health Center Inc.
  • Indiana Blood and Marrow Transplantation Research
  • Siouxland Hematology-Oncology Associates, LLP
  • Cancer Center of Kansas
  • Cancer Center of Kansas
  • Kentucky Cancer Clinic
  • Center for Cancer and Blood Disorders
  • Josephine Ford Cancer - Downriver
  • Henry Ford Medical Center- Fairlane
  • Henry Ford Hospital
  • Henry Ford Hospital - West Bloomfield
  • Regional Cancer Care Associates
  • Study Supplies: Regional Cancer Care Associates
  • Somerset Hematology Oncology Associates
  • San Juan Oncology Associates
  • Associates In Oncology and Hematology
  • The University of Texas M.D. Anderson Cancer Center
  • Hospital Italiano de la Plata
  • Hospital Privado de Cordoba
  • Centro de Investigaciones Oncologicas
  • Instituto Medico Especializado Alexander Fleming
  • Cliniques Universitaires Saint Luc
  • C.H.R.ST. - R. Fabiola (N-D)
  • University Hospital Gent - Department of Hematology
  • Centre Hospitalier de Jolimont - Lobbes
  • CHU de Charleroi - Hopital civil Marie Curie
  • H.-Hartziekenhuis Roeselare-Menen
  • Centro De Hematologia E Hemoterapia Da Unicamp
  • Vancouver General Hospital
  • University Health Network, Princess Margaret Hospital
  • Hopital Maisonneuve Rosemont
  • Instituto Oncologico del Sur
  • Instituto Oncologico
  • Ruiging Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
  • The Chinese PLA General Hospital
  • The Hematology Hospital of Chinese Academy of Medical Science
  • Fundacion Santa Fe de Bogota
  • Fundacion Cardiovascular de Colombia
  • CIOSAD Centro de Investigaciones Oncologicas
  • Institut Bergonie
  • CHU Caen - Cote de Nacre
  • Centre Hospitalier de Versailles Hopital Andre Mignot
  • Hopital EDOUARD HERRIOT
  • Hopital HOTEL DIEU
  • Hospital Archet 1
  • Centre d'Investigation Clinique- CIC INSERM802
  • CHU de Poitiers
  • Clinique Sainte Anne
  • Hopitaux Universitaires de Strasbourg - Hopital Civil
  • Charite University Medical Center - Campus Virchow Klinikum
  • Universitätsklinikum Carl Gustav Carus
  • Univeristatsklinikum Hamburg-Eppendorf
  • Universitaetsklinikum Leipzig Zentrum fur Innere Medizin
  • III. Medizinische Klinik, Universitaetsklinikum Mannheim gGmbH
  • III. Medizinischen Klinik und Poliklinik des Klinikums Rechts der Isar der TU-MUNCHEN
  • Prince Of Wales Hospital
  • Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
  • Petz Aladar Megyei Oktato Korhaz
  • Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
  • Josa Andras Hospital
  • Tata Memorial Center, Tata Memorial Hospital
  • Advanced Centre for Treatment, Research and Education in Cancer
  • Jehangir Clinical Development Centre,
  • Birla Cancer Centre
  • SEAROC Cancer Center, Soni Manipal Hospital
  • Azienda Ospedaliera San Gerardo
  • Azienda Ospedaliera Universitaria San Luigi Gonzaga
  • Ospedale Ferrarotto - Divisione di Ematologia
  • Dipartimento Di Ematologia Ospedale Santo Eugenio
  • Toyohashi Municipal Hospital
  • Akita University Hospital
  • National Hospital Organization Kyushu Cancer Center
  • Kanazawa University Hospital
  • Tohoku Univesity Hospital
  • Kinki University School Of Medicine
  • Jikei University Hospital Daisan
  • Japanese Red Cross Nagoya First Hospital
  • Aichi Cancer Center Hospital
  • Chiba University Hospital
  • Tokai University Hospital
  • Nagasaki University Hospital
  • Niigata University Medical and Dental Hospital
  • Osaka University Hospital
  • Hamamatsu Medical University Hospital Faculty of Medicine
  • Tokyo Metropolitan Cancer & Infectious Disease Centre Komagome Hp
  • The Catholic University of Korea, Seoul St. Mary's Hospital/Division of Hematology
  • Riga Centre Of Haematology
  • Hematology, Oncology & Transfusion Medicine Center
  • Centro Medico de las Americas
  • Uniwersyteckie Centrum Kliniczne
  • Samodzielny Publiczny Szpital Kliniczny Im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego
  • SP ZOZ Szpital Uniwersytecki w Krakowie
  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika
  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
  • GUZ Komi Republican Oncology Center
  • Regional State Budgetary Healthcare Institution "Barnaul City Hospital #8"
  • Sverdlovsk Regional Clinical Hospital #1
  • Central City Hospital #7
  • Kirov Research Institute of Hematology and Blood Transfusion of
  • Federal State Budget Institution Hematology Scientific Center of Minzdravsotsrazvitiya of Russia
  • State Novosibirsk Regional Clinical Hospital
  • Perm Territory State Budgetary Healthcare Inst
  • Republican Hospital na Baranov
  • Rostov Regional Clinical Hospital
  • Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
  • Leningrad Regional Clinical Hospital
  • St-Petersburg Pavlov's State Medical University
  • St-Petersburg State Medical University
  • Samara Regional Clinical Hospital M.I. Kalinin
  • St-Petersburg Pavlov's State Medical University
  • Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital
  • Singapore General Hospital
  • University Witwatersrand and Oncology
  • Johannesburg Hospital, Department of Medical Oncology
  • Clinical Haematology Unit - Department of Medicine
  • Department of Cardiology, Chris Hani Baragwanath Hospital
  • Department of Radiology, Chris Hani Baragwanath Hospital
  • Hospital Universitari Clinic de Barcelona
  • Hospital De La Princesa
  • Hospital Universitario La Paz
  • Hospital de Madrid Norte-Sanchinarro Centro Integral Oncologico
  • Complejo Hospitalario de Toledo- Servicio de Hematologia.
  • Hospital Clinico Universitario de Valencia (CHUV)
  • Changhua Christian Hospital
  • National Taiwan University Hospital
  • Division of Hematology, Department of Medicine
  • Hacettepe Universitesi Tip Fakultesi
  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
  • Gaziantep Universitesi Tip Fakultesi
  • Cherkaskiy oblasniy onkologichniy dispanser
  • Clinical Assocation of Emergency Care
  • Clinical Diagnostic Laboratory of Komunalnyj Zaklad
  • Komunalnyj Zaklad "Dnipropetrovska Miska Bagatoprofilna Klinichna Likarnja #4"
  • Instytut Nevidkladnoi ta Vidnovnoi Hirurgii im. P.K. Husaka NAMN Ukrainy, Viddilennja Hematologii
  • Oleksandrovska clinical hospital cardiological rehabilitation department
  • Miska klinichna likarnja # 9
  • Institut Klinichnoi Radiologii DU "Natsionalnyj Naukovyj Centr Radiacijnoi Medicini NAMN Ukraini"
  • Institut Klinichnoi Radiologii Naukovogo Centru Radiacijnoi Medicini NAMN Ukraini
  • Institut Klinichnoi Radiologii Naukovogo
  • Ultrasaund Educational and Diagnostic Center
  • Instutut Patologii Krovi to Transfuziynoi Medicinu AMN Ukraini
  • Polyclinic of 5th Municipal Hospital
  • 3rd Floor Centre for Clinical Haematology
  • The Park Hospital
  • Hammersmith Hospital Clinical Trial Units
  • Good Hope Hospital
  • Birmingham Heartlands Hospital
  • Department of Haematology - Level 3, Bexley Wing
  • Department of Haematology
  • Hammersmith Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Bosutinib

Imatinib

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
December 13, 2007
Last Updated
December 19, 2018
Sponsor
Pfizer
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00574873
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 5, 2008 (Actual)
Primary Completion Date
August 31, 2010 (Actual)
Study Completion Date
May 27, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
Bosutinib, imatinib, CML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bosutinib
Arm Title
2
Arm Type
Active Comparator
Arm Description
Imatinib
Intervention Type
Drug
Intervention Name(s)
Bosutinib
Other Intervention Name(s)
SKI 606
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
imatinib
Other Intervention Name(s)
Gleevec
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1
Description
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.
Time Frame
Year 1 (48 weeks)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Major Molecular Response (MMR) at Year 1
Description
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.
Time Frame
Year 1 (48 weeks)
Title
Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks
Description
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.
Time Frame
192 weeks
Title
Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks
Description
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.
Time Frame
192 weeks
Title
Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks
Description
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.
Time Frame
144 weeks
Title
Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks
Description
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.
Time Frame
192 weeks

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
35235189
Citation
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.
Results Reference
derived
PubMed Identifier
24944159
Citation
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.
Results Reference
derived
PubMed Identifier
24919837
Citation
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.
Results Reference
derived
PubMed Identifier
23116602
Citation
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.
Results Reference
derived
PubMed Identifier
22949154
Citation
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.
Results Reference
derived
PubMed Identifier
22825216
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3160A4-3000&StudyName=Compare%20Bosutinib%20To%20Imatinib%20In%20Subjects%20With%20Newly%20Diagnosed%20Chronic%20Phase%20Philadelphia%20Chromosome%20Positive%20CML
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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