Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03590171
PHASE2

International Study for Treatment of High Risk Childhood Relapsed ALL 2010

Sponsor: Charite University, Berlin, Germany

View on ClinicalTrials.gov

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

Interventions

DRUG

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