Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia

The purpose of this clinical research study was to establish a recommended phase 2 once daily (QD) dose of dasatinib and to assess the efficacy of the investigational drug for relapsed or refractory (resistant to previous treatment) leukemia in children and adolescents. The side effects that this oral investigational drug may have in children, and the levels of the drug in the blood, will be studied at different doses.


Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of SRC/ABL Tyrosine Kinase Inhibitor Dasatinib [BMS-354825] in Children and Adolescents With Relapsed or Refractory Leukemia, Protocol ITCC 005
Enrollment: 63
Actual Study Start Date: February 22, 2006
Estimated Study Completion Date: October 4, 2022
Primary Completion Date: May 25, 2011 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Stratum 1 (Ph+ CP-CML)
- Experimental: Stratum 2/3 (Ph+ ALL or AP/BP-CML)
- Experimental: Stratum 4 (Ph- ALL/AML)