drugset / Trial / NCT03590171
International Study for Treatment of High Risk Childhood Relapsed ALL 2010
Phase 2
Recruiting
250 enrolled
Charite University, Berlin, Germany
Australian & New Zealand Children's Haematology/Oncology Group · collabCentre Hospitalier Universitaire de Nice · collabEuropean Organisation for Research and Treatment of Cancer - EORTC · collabInstituto Português de Oncologia de Lisboa (co-sponsor, Portugal) · collabKarolinska University Hospital Stockholm (co-sponsor, Sweden) · collabManchester University NHS Foundation Trust · collabOslo University Hospital (co-sponsor, Norway) · collabOspedale Pediatrico Bambino (co-sponsor, Italy) · collabOur Lady's Chilrden's Hospital (Co-Sponsor Ireland) · collabPrinses Máxima Centrum (Co-Sponsor Netherlands) · collabRigshospitalet, Denmark · collabSpanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain) · collabSt. Anna Kinderkrebsforschung, CCRI (co-sponsor, Austria) · collabTel Aviv Sourasky Medical Centre (Co-Sponsor Israel) · collabTurku University Central Hospital (co-sponsor, Finland) · collabUniversity Children's Hospital, Zurich · collabUniversity Hospital, Motol · collabWroclaw Medical University · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-09-01
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |