Conditions: Leukemia
Keywords: Chronic Phase, Advanced Phase chronic myeloid leukemia Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 121
Healthy volunteers: no

Brief summary:
The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR) rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib, or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP CML and Ph+ALL).

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: Tablets, Oral, 70 mg BID (AD CML) or 100 mg QD (Chronic CML), once or twice daily dependent on disease stage, until subjects meet discontinuation (DC) criteria for study

Protocol document: