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

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 Type: Interventional  (Clinical Trial)
Actual Enrollment: 145 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: February 19, 2009
Actual Primary Completion Date: September 1, 2016
Estimated Study Completion Date: September 23, 2021

Arms:
- Experimental: Cohort 1: CP-CML
- Experimental: Cohort 2: Ph+ALL or AP- or BP-CML
- Experimental: Cohort 3: Newly diagnosed, treatment naïve CP-CML