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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 - NCT00777036-98105(Clinical Trial 486501)



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City:  Seattle
State:  
WA
Zip Code: 98105
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
Study is available at: Seattle Children'S Research Institute
Seattle, WA 98105
United States

Primary Contact:
Blythe Thomson, Site 028
Phone: 206-987-1426

Secondary Contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email: Clinical.Trials@bms.com
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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