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
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Intervention: Dasatinib
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 1 Day
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia, Pediatric

Summary:

      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
    

Eligibility criteria:

        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