International Study for Treatment of High Risk Childhood Relapsed ALL 2010 - A randomized Phase II Study Conducted by the Resistant Disease Committee of the International BFM Study Group.
Phase 2
Recruiting
- Conditions
- Acute lymphoblastic leukemiablood cancer10024324
- Registration Number
- NL-OMON49335
- Lead Sponsor
- Charité University Medicine Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Relapsed precursor B-cell or T-cell ALL
Children less than 18 years
High-risk relapse (in study-protocol defined criteria)
Written informed consent
Exclusion Criteria
BCR/ABL positive ALL
Pregnancy/breast feeding
Relapse post stemcell transplant
No consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Randomized induction trial:<br /><br>*Rates of CR2 with standard chemotherapy + Bortezomib (Arm B) compared with<br /><br>standard chemotherapy (Arm A), quantified by cytology</p><br>
- Secondary Outcome Measures
Name Time Method <p>*Three years EFS and OS<br /><br>*Rate of patients reaching HSCT<br /><br>*MRD rates post-induction and pre-HSCT<br /><br>*Prognostic relevance of MRD pre HSCT, CR2 and MRD rates during consolidation<br /><br>*Toxicity of randomized arms</p><br>