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
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).
Phase
Phase 4 - refines the treatment to become part of standard care.Inclusion and Exclusion 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.
- 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.
Sites
Please contact Gangothri Namasivayam to learn more about where you can participate in this trial. Please use the contact form on the right side.
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