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Spots Global Cancer Trial Database for Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors

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Trial Identification

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

Interventions

Bosutinib

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Pfizer CT.gov Call Center

Affiliation: Pfizer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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