A Study to Document the Long-Term Safety and Efficacy of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Previous Treatment and Have Completed the Previous Phase I/II Protocol (CA180-031/NCT00337454)

简要总结

主要结局

次要结局

• Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response(At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter)
• Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response(At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter)
• Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR)(At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454),)
• Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response(At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454))
• Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR)(At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter)
• Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR)(At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454))
• Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR)(At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter)
• Participants With CML-CP: Time to Major Cytogenetic Response (MCyR)(At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454))
• Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR)(At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter)
• Participants With CML-CP: Duration of Major Cytogenetic Response (MCyR)(At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454))
• Participants With CML-AP/BP and Ph+ ALL: Duration of Major Cytogenetic Response (MCyR)(At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter)
• Participants With CML-CP: Percentage of Participants With Complete Hematologic Response (CHR)(baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454), every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation)
• Participants With CML-AP/BP: Percentage of Participants With Hematologic Response(baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation)
• Participants With Ph+ ALL: Percentage of Participants With Hematologic Response(baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation)
• Time to Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL(baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation)
• Duration of Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL(baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation)
• Time to Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL(baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation)
• Duration of Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL(baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation)
• Time to Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL(baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation)
• Duration of Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL(baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation)
• Participants With Detectable Mutations of RNA (mRNA) of BCR-ABL at Baseline and at Best Achievement(At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter, and at discontinuation)
• Status of Point Mutations of BCR-ABL at Baseline (BL) and End of Study (EOS)(At baseline and discontinuation--the study period was extended until the launch of dasatinib in Japan, January 2009.)
• Collection of Blood Samples for Pharmacokinetic Analysis of Dasatinib Twice Daily (BID) That Will Contribute to Population Pharmacokinetic Modeling(At any visit of later than Day 7, draw sample(s) at pretreatment trough (within 1 hour prior to dosing) or between 3 hours following treatment and prior to the next dose)