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This study evaluates the drug Dasatinib in children and adolescents with newly diagnosed chronic phase Chronic Myelogenous Leukemia (CML) or with Philadelphia chromosome-positive leukemias resistant or intolerant to imatinib. It included pediatric patients with adequate liver and kidney function. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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