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

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 ≥12 weeks
• Adequate hepatic and renal function
• Written informed consent
• Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation
• Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy
• Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2
• Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible
• Target Population for the PK substudy subjects must meet relevant inclusion criteria

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
• Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria
• Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy Other inclusion/exclusion criteria may apply