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9L-14-3: A Phase 4 Safety And Efficacy Study Of Bosutinib (Bosulif) In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors

Description

The study drug, bosutinib is a tyrosine kinase inhibitor (TKI) that has been approved for the treatment of adult patients with Philadelphia chromosome positive chronic phase chronic myelogenous leukemia (CML) previously treated with other TKI therapy. CML is the fourth most commonly occurring adult leukemia. The transformation of CML from a deadly cancer to a chronic illness that took place over the last decade has been to the development of TKIs (inhibitors of the kinase activity of BCR-ABL1). The purpose of this phase 4 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 Ph+ CML patients with high unmet medical need, including 75 chronic phase (CP), accelerated phase( AP) or BP(blastic phase) participants in the 4th or later line treatment setting. The primary objectives of this study are to estimate the 1-year (Week 52) probability of cumulative Major Cytogenetic Response (MCyR) in CP Ph+ CML patients with 1 or 2 prior lines of TKI therapy or 3 or more prior lines of TKI therapy. And to estimate the 1-year (Week 52) probability of cumulative confirmed Overall Hematological Response (OHR) in AP and BP Ph+ CML patients with any prior TKI therapy.This is a single-arm, open-label, non-randomized, multi-center Phase 4 study to evaluate bosutinib (Bosulif ) in patients with CP/AP/BP Ph+ CML whose disease has failed prior treatment with commercially available TKIs due to drug resistance or intolerance, or are otherwise contraindicated for treatment with commercially available TKIs such as imatinib, dasatinib, or nilotinib.Participants will receive bosutinib for at least 4 years from the time of first dose. Participants discontinuing bosutinib before completing at least 4 years of therapy will be followed for survival until they complete at least 4 years on study. Participants completing at least 4 years of bosutinib with continued benefit may be switched to commercially available therapy at that time. During the first 3 months of study, disease assessments will be performed weekly during the first month, then approximately every 4 weeks until Week 13. Assessments will then be performed every 3 months until Week 52, then at 6 month intervals during year 2, 3, and 4 of treatment.This study does not include any formal sample size determination. All treated Ph+ participants will be included in the efficacy analyses. Analyses will be presented by disease stage and/or line of therapy. The exploratory time-to-event endpoints of OS and PFS will be summarized using the Kaplan-Meier method or by cumulative incidence, whichever is more appropriate.

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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