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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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