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Brief Title: Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
Official Title: A PHASE 4 SAFETY AND EFFICACY STUDY OF BOSUTINIB (BOSULIF (REGISTERED)) IN PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA PREVIOUSLY TREATED WITH ONE OR MORE TYROSINE KINASE INHIBITORS
Study ID: NCT02228382
Brief Summary: The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other Tyrosine Kinase Inhibitors).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Keck Hospital of USC, Los Angeles, California, United States
LAC+USC Medical Center, Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Sylvester Deerfield Beach, Deerfield Beach, Florida, United States
University of Miami Hospital & Clinics, Miami, Florida, United States
Indiana Blood and Marrow Transplantation-Clinic, Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Siteman Cancer Center - West County, Creve Coeur, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center - South County, Saint Louis, Missouri, United States
Weill Cornell Medical College - New York-Presbyterian Hospital, New York, New York, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Medizinische Universitaet Innsbruck, Innsbruck, , Austria
Ordensklinikum Linz Gmbh Barmherzige Schwestern, Linz, , Austria
Institut Bergonie, Bordeaux Cedex 09, , France
Centre Hospitalier de Versailles (CHV)-Hopital Andre Mignot Service d'Hematologie Clinique- Oncology, Le Chesnay Cedex, , France
Centre Regional De Lutte Contre Le Cancer, Marseille, , France
Hopital Archet I, Nice Cedex 3, , France
Institut Universitaire du Cancer Toulouse - Oncopole, Toulouse Cedex 9, , France
CHU Brabois, Vandoeuvre-les-Nancy cedex, , France
RWTH Uniklinik Aachen Klinik fur Onkologie, Hamatologie und Stammzelltransplantation, Aachen, , Germany
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK), Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Klinik fur Innere Medizin II, Jena, , Germany
Universitaetsklinikum Koeln (AoeR), Koeln, , Germany
III. Medizinische Klinik Universitaetsmedizin Mannheim, Mannheim, , Germany
AOU Policlinico Consorziale di Bari - UO Ematologia con Trapianto, Bari, BA, Italy
A.O.U. Policlinico S. Orsola-Malpighi, Bologna, BO, Italy
Azienda Socio Sanitaria Territoriale - ASST Monza, Monza, MB, Italy
Ospedale S. Eugenio - UOC Ematologia, Rome, RM, Italy
AOU San Luigi Gonzaga SCDU Medicina Interna II ad indirizzo Ematologico, Orbassano, TO, Italy
AOU Policlinico Vittorio Emanuele-P.O.G. Rodolico, Catania, , Italy
SOD Ematologia, Firenze, , Italy
A.O. Ospedale Niguarda Ca Granda - SC Ematologia, Milano, , Italy
Haukeland Universitetssjukehus, Bergen, , Norway
St Olav Hospital, Trondheim, , Norway
Hospital Universitario Quiron Madrid, Pozuelo de Alarcon, Madrid, Spain
Hospital Universitari Vall d' Hebron, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic De Barcelona, Barcelona, , Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Hospital de dia Quiron Zaragoza, Zaragoza, , Spain
Hematologiskt centrum, Stockholm, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR