Status:
COMPLETED
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Leukemia
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
Brief Summary
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 lymphob...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- 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
- Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation
- Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy
- Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2
- Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible
- Target Population for the PK substudy subjects must meet relevant inclusion criteria
Exclusion
- 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
- Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria
- Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy
- Other inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 20 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2025
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00777036
Start Date
March 20 2009
End Date
January 27 2025
Last Update
August 29 2025
Active Locations (174)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Birmingham, Alabama, United States, 35233
2
Local Institution - 0005
Phoenix, Arizona, United States, 85016
3
Phoenix Children'S Hospital
Phoenix, Arizona, United States, 85016
4
Jonathan Jaques Children'S Cancer Center
Long Beach, California, United States, 90801-1428