Safety and Efficacy Study of Bosutinib in Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated with one or two more Tyrosine Kinase Inhibitors

Update Il y a 4 ans
Reference: EUCTR2013-003250-25

Woman and Man

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Extract

Primary Objectives •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. •To estimate the 1-year (Week 52) probability of cumulative MCyR in CP Ph+ CML patients with 3 or more prior lines of TKI therapy. •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.


Inclusion criteria

  • Philadelphia Chromosome Positive Chronic Myeloid Leukaemia