Phase II trial of dasatinib (DAS) in pediatric patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP).

10511Background: Safe and effective treatment options for newly diagnosed (ND) or imatinib (IM) resistant/intolerant (R/I) pediatric CML pts are limited, and a large prospective study is needed. DAS has proven safety and efficacy in adults with ND or IM-R/I CML and is now being evaluated in a phase II trial of pediatric pts. Methods: CA180-226/NCT00777036 is an open-label nonrandomized prospective study of pts aged 30% and CCyR >55% considered of clinical interest). Results: 113 pediatric CML-CP pts were treated. Cumulative rate of MCyR >30% was reached as early as 3 mo (55%; [95% CI 36, 74]) for IM-R/I CML-...