Conditions: Chronic Myeloid Leukemia Philadelphia-Positive Myeloid Leukemia
Keywords: Chronic phase Philadelphia chromosome chronic myeloid leukemia (Ph+CML)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 387
Healthy volunteers: no

Brief summary:
The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.

Detailed description:

Arms:
arm 1: Dasatanib, 70 mg twice daily (BID), with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: Tablets; oral; 70 mg BID, depending on response

Protocol document: