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International Study for Treatment of High Risk Childhood Relapsed ALL 2010
Sponsor: Charite University, Berlin, Germany
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.
Official title: 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 Berlin, Frankfurt, Münster (BFM) Study Group
Key Details
Gender
All
Age Range
Any - 17 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2017-09-01
Completion Date
2027-12-31
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (15)
Australian & New Zealand Childhood Hematology & Oncology Group
Clayton, Victoria, Australia
St. Anna Kinderkrebsforschung, CCRI
Vienna, Austria
Hòpital Universitaire des Enfants Reine Fabiola
Brussels, Belgium
University Hospital Motol
Prague, Czechia
Copenhagen University Hospital (Rigshospitalet)
Copenhagen, Denmark
Turku University Central Hospital
Turku, Finland
CHU Nice
Nice, France
Tel Aviv Sourasky Medical Centre
Tel Aviv, Israel
Ospedale Pediatrico Bambino Gesù
Roma, Italy
Prinses Máxima Centrum, Lundlaan
Utrecht, Netherlands
Oslo University Hospital
Oslo, Norway
Dpt. SCT and Hematology/Oncology University Wroclaw
Wroclaw, Poland
Instituto Português de Oncologia de Lisboa
Lisbon, Portugal
University Hospital Stockholm
Stockholm, Sweden
Royal Manchester Children's Hospital
Manchester, United Kingdom