Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.
University Hospitals Leuven
Leuven, Belgium
Children Oncology Group Operations centres
Monrovia, Canada
Gustave Roussy
Villejuif, France
2nd Dept. of Pediatrics Semmelweis Univ.
Budapest, Hungary
Event free survival
Minimum time to death from any cause, presence of viable cells in residue after 6th DA-EPOCH course, relapse, progressive disease, or second malignancy measured from registration.
Time frame: 36 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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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