Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
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).
Checked against the public recordLast updated Dec 30, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 4
- Sponsor
- Pfizer
- Interventions being studied
- Drug: Bosutinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Keck Hospital of USCLos Angeles, California
- LAC+USC Medical CenterLos Angeles, California
- USC/Norris Comprehensive Cancer CenterLos Angeles, California
- Sylvester Deerfield BeachDeerfield Beach, Florida
- University of Miami Hospital & ClinicsMiami, Florida
- Indiana Blood and Marrow Transplantation-ClinicIndianapolis, Indiana
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland
- Siteman Cancer Center - West CountyCreve Coeur, Missouri
- Barnes-Jewish HospitalSt Louis, Missouri
- Washington University School of MedicineSt Louis, Missouri
- Siteman Cancer Center - South CountySt Louis, Missouri
- Weill Cornell Medical College - New York-Presbyterian HospitalNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 30, 2021. Always confirm current availability with the study team.