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
Active, Not Recruiting
