B-NHL BFM Rituximab

B-NHL BFM Rituximab B-NHL BFM Rituximab: multicentre Phase-II therapy trial with a Rituximab-Window before chemotherapy for the treatment of children and adolescents with mature B-Cell-Non-Hodgkin-Lymphoma or mature B-ALL.
Disease Mature B-Cell Non-Hodgkin-Lymphoma (alle stages of disease but I-R und II-R), mature B-ALL
Type Multicentre trial; Phase II-trial
Problem / Objectives
  • Evaluation of the response of mature B-NHL und B-ALL of children and adolescents to the Rituximab-Window before the chemotherapy.
  • Evaluation of the efficiency of Rituximab for this group of patients
  • Documentation and evaluation of the toxicity of Rituximab
Therapy / Study arms

Procedure: day 1 of the trial: 375mg/m2 Rituximab as monotherapy; day 5: Evaluation of the response; subsequently follows the chemotherapy of the B-NHL 04 trial.

Inclusion Criteria
  • new diagnosed histologicaly / immunohistochemicaly or cytomorphologicaly/ immunologicaly confirmed mature B-NHL or B-ALL
  • immunologicaly or immunochemicaly proof of a CD20-Expression of the lymphocytes (or FAB-3 morphology, if results are still missing).
  • stratification in therapy-arm R2, R3 or R4
  • written informed consense
  • diagnosis before the 19th birthday
  • no pregnancy or lactation
  • no significant therapy before start of the trial
Recruitment min.. 79
Status 01.05.2004
Principal Investigator Prof. Dr. med. Alfred Reiter
E-Mail nhl.studie@paediat.med.uni-giessen.de
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Documentation

Participants All participants of the B-NHL-BFM trial
Sponsoring Deutsche Kinderkrebsstiftung