Myeloproliferative Neoplasms Clinical Trial
Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
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 leukemia-cml/" >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).
Eligibility Criteria
Inclusion Criteria:
Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative Chronic Myeloid Leukemia (from initial diagnosis).
Prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).
Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to receive treatment with imatinib, dasatinib and/or nilotinib for any reason.
Exclusion Criteria:
Participation in any other clinical studies involving investigational drug(s) within 14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to the first dose of bosutinib.
Prior treatment with bosutinib.
Prior treatment with ponatinib.
Known T315I or V299L mutation.
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There are 44 Locations for this study
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Deerfield Beach Florida, 33442, United States
Miami Florida, 33136, United States
Indianapolis Indiana, 46237, United States
Baltimore Maryland, 21287, United States
Creve Coeur Missouri, 63141, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63129, United States
New York New York, 10021, United States
Seattle Washington, 98109, United States
Innsbruck , 6020, Austria
Linz , 4010, Austria
Bordeaux Cedex 09 , 33076, France
Le Chesnay Cedex , 78157, France
Marseille , 13009, France
Nice Cedex 3 , 06202, France
Toulouse Cedex 9 , 31059, France
Vandoeuvre-les-Nancy cedex , 54511, France
Aachen , 52074, Germany
Berlin , 13353, Germany
Hamburg , 20246, Germany
Jena , 07747, Germany
Koeln , 50937, Germany
Mannheim , D-681, Germany
Bari BA, 70124, Italy
Bologna BO, 40138, Italy
Monza MB, 20900, Italy
Rome RM, 00144, Italy
Orbassano TO, 10043, Italy
Catania , 95123, Italy
Firenze , 50134, Italy
Milano , 20162, Italy
Bergen , 5021, Norway
Trondheim , 7030, Norway
Pozuelo de Alarcon Madrid, 28223, Spain
Barcelona , 08035, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28006, Spain
Madrid , 28034, Spain
Salamanca , 37007, Spain
Valencia , 46026, Spain
Zaragoza , 50012, Spain
Stockholm , 171 7, Sweden
Uppsala , 751 8, Sweden
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