Official Title
Study of Dasatinib (BMS-354825) in Subjects With Chronic Phase or Advanced Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Who Are Resistant to or Intolerant of Imatinib Mesylate
Brief Summary

This protocol allows CML and Ph+ ALL subjects who are resistant to or intolerant of imatinib mesylate, to potentially benefit from dasatinib. It is intended to provide patients with access to dasatinib while awaiting reimbursement decision in Korea and it will also provide additional data on the safety of dasatinib in Korean population

Status
Approved for marketing
Conditions
Leukemia
Interventions

Drug: Dasatinib
tablet, Oral, 140mg/day, BID, until;
the time of reimbursement in Korea
the application for marketing authorization is withdrawn
the application for marketing authorization is denied
Other Name: Sprycel
Other Name: BMS-354825

Eligibility Criteria

Inclusion Criteria: - Clinical diagnosis of CML or Ph+ ALL who have primary or acquired resistance to or intolerance of imatinib mesylate - ECOG performance status score 0 - 2 - Adequate hepatic, renal function

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Korea, Republic of
Investigators

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb, Korea

Sponsors / Collaborators
Bristol-Myers Squibb
NCT Number
NCT00454753
Keywords
Myeloid
Chronic
Lymphocytic
Acute
MeSH Terms
Leukemia
Dasatinib
Intervention Name
Dasatinib