The aim of the trial is to test whether adding 6 injections of rituximab to standard "Lymphome malin B" LMB chemotherapy regimen improves the Event Free Survival (EFS) compared with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH \> Nx2, any stage IV or B-AL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
482
Prephase (COP) for all groups followed by: in group B: 4 courses: 2 COPADM + 2 CYM, with MTX 3g/m² in group C: 6 courses: 2 COPADM + 2 CYVE + 2 maintenance courses, with MTX 8g/m², in 4h in C1, in 24h in C3 (except the 1st course) and CNS positive patients receive additional IT before each CYVE courses and HDMTX between CYVE courses.
LMB chemo as in the comparator arm Rituximab 375 mg/m² i.v.: 6 injections: two doses at 48h interval are given at D-2 and D1 of the 2 first courses (COPADM) and one dose at the beginning of the 2 following courses (CYM or CYVE).
University Hospitals Leuven
Leuven, Belgium
Children Oncology Group Operations centres
Monrovia, Canada
The University of Hong Kong (Clinical Trials Centre)
Hong Kong, China
Institut de Cancérologie Gustave roussy
Villejuif, France
2nd Dept. of Pediatrics Semmelweis Univ.
Budapest, Hungary
Associazione Italiana di Ematologia ed Oncologia Pediatrica
Padova, Italy
Emma Children's Hospital
Amsterdam, Netherlands
Rectorat of Medical University
Wroclaw, Poland
Sociedad Española de Hematología y Oncología Pediátricas
Valencia, Spain
University of Birmingham
Birmingham, United Kingdom
Event free survival
Minimum time to death from any cause, presence of viable cells in residue after \[2nd (Rituximab-)CYVE\], relapse, progressive disease, or second malignancy measured from randomization.
Time frame: 24 months
Survival
Overall survival
Time frame: 5 years
Acute toxicity
Acute toxicity during treatment according to NCI-CTC V4
Time frame: 6 months
Long term toxicity
Long term toxicity, especially immune reconstitution, cardiac toxicity
Time frame: 5 years
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