International Study for Treatment of Standard Risk Childhood Relapsed A
Phase 2
Completed
- Conditions
- <p>IntReALL, Relapsed ALL 2010</p>10024324
- Registration Number
- NL-OMON27511
- Lead Sponsor
- Charité Unversity Medizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
|
Eerste recidief voorloper-B ALL (BCP-ALL) of T-ALL |
Exclusion Criteria
|
BCR-ABL / t(9;22) positieve ALL |
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary parameters:<br /><br>- Overall: Improvement of event-free survival (EFS) probabilities in childhood relapsed ALL<br /><br>- Randomization 1: EFS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR patients<br /><br>- Randomization 2: Influence of epratuzumab on EFS in consolidation of SR patients</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters:<br /><br>- OS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR patients<br /><br>- Influence of epratuzumab on OS in consolidation of SR patients<br /><br>- Rate of second complete remission (CR2) of Arm A versus Arm B<br /><br>- Rate of SCT performed in Arm A versus Arm B<br /><br>- Toxicity of randomized SR arms A versus B<br /><br>- Toxicity of consolidation with versus without epratuzumab<br /><br>- Improvement of MRD reduction during consolidation with versus without epratuzumab<br /><br>- Rate of MRD negativity prior to SCT with Arm A vs. Arm B<br /><br>- Rate of MRD negativity prior to SCT after consolidation with versus without epratuzumab<br /><br>- Pharmacokinetic of epratuzumab in context with arm A and arm B</p><br>