Bortezomib for children with acute lymphoblastic leukemia (ALL) without other treatment options.
Completed
- Conditions
- acute lymphoblastic leukemiarelapserefractorychildren
- Registration Number
- NL-OMON23341
- Lead Sponsor
- Erasmus MC, Rotterdam, Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Age between 6 months and 19 years;
2. Patients with a second or subsequent relapsed ALL;
Exclusion Criteria
1. Relapse not involving bone marrow;
2. Symptomatic CNS leukemia;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL.
- Secondary Outcome Measures
Name Time Method 1. Determine the feasibility and safety of combining bortezomib with conventional combination chemotherapy in children and adolescents with relapsed/refractory ALL;<br /><br>2. Evaluate bortezomib levels and proteasome inhibition in cerebrospinal fluid, bone marrow and peripheral blood in patients with relapsed/refractory ALL, and assess the relationship to the efficacy and toxicity of bortezomib.<br>