Woman and Man
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Extract
The primary objective of this study is to compare the rate of major molecular response of dasatinib (100 mg QD) to high-dose imatinib (800 mg, i.e. 400 mg BID) therapy at 12 months in chronic phase CML subjects, who had achieved only a suboptimal response after at least 3 months imatinib (400 mg) monotherapy prior to enrollment. A suboptimal response is defined as a hematologic response but less than Complete HR after at least 3 months; a cytogenetic response but less than a partial cytogenetic response (PCgR) after at least 6 months; a partial cytogenetic response after at least 12 months, or less than a major molecular response with complete cytogenetic response after at least 18 months. Additional 12 months of treatment: The primary objective is to collect longer term efficacy on dasatinib in terms of duration of major molecular response.
Inclusion criteria
- Subjects with Ph+ chronic phase Chronic Myeloid leukemia (CML)