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Bristol-Myers Squibb

Korean Early Access Program

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
Approved for marketing

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the application for marketing authorization is withdrawn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: 
Eligibility Age: 
Minimum: 18 Years
Korea, Republic of

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

Bristol-Myers Squibb
EA Number: 
Myeloid, Chronic, Lymphocytic, Acute
MeSH Terms: 
Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Dasatinib
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