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

Status: Recruiting
Phase: Phase 2
Diagnosis: Pediatric Leukemia, Pediatric Oncology
NCT ID: NCT00777036 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-084


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


Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Barbara Degar, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility 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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