Active, Not Recruiting
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 - CA180-226
Updated:
31 August, 2023
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ClinicalTrials.gov
Phase
Gender(s)
Active, Not Recruiting
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
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