A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Conducting Institutions:

Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:

Site-responsible Investigators:

Contacts:

Eligibility Criteria

Inclusion Criteria:



  -  CP-CML who prove resistant or intolerant to imatinib (cohort #1)



  -  Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after

     imatinib therapy (cohort #2)



  -  Newly diagnosed, treatment naive CP-CML (cohort #3)



  -  Lansky or Karnofsky scale > 50



  -  Life expectancy Ì¢‰Û¡å´ 12 weeks



  -  Adequate hepatic and renal function



  -  Written informed consent



Exclusion Criteria:



  -  Eligibility for potentially-curative therapy including hematopoietic stem-cell

     transplantation



  -  Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal

     disease)



  -  Isolated extramedullary disease



  -  Prior therapy with dasatinib