Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents

• Status: Recruiting
• Trial end date: 2024-08-01

Summary

The trial B-NHL 2013 is a collaborative prospective, multi-national, multi-center, randomized trial with participating centers of the NHL-BFM group (Austria, Switzerland, Czech Republic, Germany) and the Scandinavian NOPHO group (Denmark, Finland, Norway, Sweden). The aim of the trial is to evaluate the role of rituximab in the treatment of mature aggressive B-cell Non-Hodgkin lymphoma and leukemia (B-NHL and B-AL) in children and adolescents.

The following primary study questions are going to be analyzed:

• the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 and R2 stage I and II) of substituting anthracyclines by the rituximab window without compromising survival rates.

• the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 stage III) randomly assigned to receive the rituximab window plus standard chemotherapy or standard chemotherapy without the rituximab window.

• the effectiveness (event-free survival) and the immune reconstitution (recovery of CD19+ B-cells, IR) in pediatric patients with advanced mature B-NHL/B-AL (R3 and R4 incl. R4 CNS+) treated with BFM-type chemotherapy and randomly assigned schedules of one versus seven doses rituximab.

Secondary study questions will address

• additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates

• kinetics of immune reconstitution after treatment

• adverse event and severe adverse event profile

• inter-individual variability of rituximab response

• role of different mechanisms of action of rituximab in advanced B-NHL/B-AL

• Phase: Phase 3

Details

• Lead Sponsor: University Hospital Muenster
• Collaborator: Deutsche Krebshilfe e.V., Bonn (Germany)
• Treatments: Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Etoposide; Ifosfamide; Liposomal doxorubicin; Methotrexate; Prednisolone; Rituximab; Vincristine; Vindesine