International Study for Treatment of High Risk Childhood Relapsed A

Phase 2

Recruiting

• Conditions: <tr><td>Relapsed High-Risk childhood leukemia</td></tr>; Relapsed ALL; 10024324

• Registration Number: NL-OMON26156
• Lead Sponsor: Charité University Medicine Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

|
Recidief voorloper B-cel of T-cel ALL |

Exclusion Criteria

|
BCR/ABL positieve ALL |

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br><tr><br><td>Randomized induction trial:<br /><br>*Rates of CR2 with standard chemotherapy + Bortezomib (Arm B) compared with standard chemotherapy (Arm A), quantified by cytology&nbsp;</td><br></tr><br><br>

Secondary Outcome Measures

Name	Time	Method
<br><tr><br><td>*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</td><br></tr><br><<br>