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).
Name: Bosutinib
Description: 100 mg and 500 mg tablets, once daily dosage up to 4 years durationType: DrugBosutinib
Description: Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive cells in metaphase from Bone Marrow sample.
Measure: Percentage of Participants with Major Cytogenetic Response (MCyR) by Week 52 in Chronic Phase Second-line Population and Chronic Phase Third-line Population of Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients. Time: Week 52Description: Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive cells in metaphase from Bone Marrow sample.
Measure: Percentage of Participants with Major Cytogenetic Response (MCyR) by Week 52 in Chronic Phase Fourth-line and later-line Population of Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients. Time: Week 52Description: OHR includes Complete Hematological Response (CHR) or return to chronic phase (RCP).
Measure: Percentage of Participants with Overall Hematologic Response (OHR) by Week 52 in Advanced Leukemia Population patients. Time: Week 52Description: Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive cells in metaphase from Bone Marrow sample.
Measure: Estimate cumulative probability of Percentage of Participants with Major Cytogenetic Response in Chronic Phase and Advanced Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia patient populations. Time: Week 52Description: OHR includes Complete Hematological Response (CHR) or return to chronic phase (RCP).
Measure: Estimate cumulative probability of Percentage of Participants with Overall Hematologic Response in the Accelerated Phase and Blast Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia patient population by number of lines of prior therapy. Time: Week 52There are 2 SNPs
- Known T315I or V299L mutation. --- T315I ---
- Known T315I or V299L mutation. --- T315I --- --- V299L ---