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A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib - NCT00777036-77030(Clinical Trial 532067)



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City:  Houston
State:  
TX
Zip Code: 77030
Conditions: Leukemia
Purpose: 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
Study summary:
Criteria: 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 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
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Data Source: ClinicalTrials.gov
Date Processed: June 11, 2010
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