International Study for Treatment of High Risk Childhood Relapsed ALL 2010
Condition(s) studied
Investigational drug(s) / intervention(s)
Bortezomib: Patients randomised to the HR-B arm receive induction, consolidation with the modified ALL R3 protocol. In this arm, patients are randomized to receive Bortezomib together with the ALL R3 protocol during induction. Administration of Bortezomib: 1.3 mg/m2 as intravenous bolus or subcutaneously (SC, at the discretion of the treating physician) on days 1 and 4 of weeks 1 and 3.
Study summary
The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.
Eligibility
Primary outcome measure(s)
- Rate of Complete Remission — Week 4
Rate of complete second remission (CR2) quantified by cytology after induction with standard chemotherapy + bortezomib (arm B) compared with standard chemotherapy (arm A).
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| Australian & New Zealand Childhood Hematology & Oncology Group | Clayton | Victoria | Recruiting |
| St. Anna Kinderkrebsforschung, CCRI | Vienna | Austria | Recruiting |
| Hòpital Universitaire des Enfants Reine Fabiola | Brussels | Belgium | Recruiting |
| University Hospital Motol | Prague | Czechia | Recruiting |
| Copenhagen University Hospital (Rigshospitalet) | Copenhagen | Denmark | Not Yet Recruiting |
| Turku University Central Hospital | Turku | Finland | Recruiting |
| CHU Nice | Nice | France | Recruiting |
| Tel Aviv Sourasky Medical Centre | Tel Aviv | Israel | Recruiting |
| Ospedale Pediatrico Bambino Gesù | Roma | Italy | Recruiting |
| Prinses Máxima Centrum, Lundlaan | Utrecht | Netherlands | Recruiting |
| Oslo University Hospital | Oslo | Norway | Not Yet Recruiting |
| Dpt. SCT and Hematology/Oncology University Wroclaw | Wroclaw | Poland | Recruiting |
| Instituto Português de Oncologia de Lisboa | Lisbon | Portugal | Not Yet Recruiting |
| University Hospital Stockholm | Stockholm | Sweden | Not Yet Recruiting |
| Royal Manchester Children's Hospital | Manchester | United Kingdom | Not Yet Recruiting |
More Charite University, Berlin, Germany trials in Sweden
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03590171 on ClinicalTrials.gov ↗ ← All trials in Sweden