Previous study of Czech Lymphoma Study Group (4_2002)have shown that intensive induction (MegaCHOP - Cyclophosphamide 3 g/m2, Vincristine 2 mg, Adriamycin 75 mg/m2, Prednisone 300 mg/m2 every three weeks with G-CSF for three cycles, followed by ESHAP - Etoposide 240 mg/m2, Cisplatin 100 mg/m2, Solumedrol 2000 mg and cytarabine 2000 mg/m2 for three cycles every three weeks with G-CSF) followed by intensive consolidation (BEAM) and stem cell support improves progression-free survival in adult patients (18-65 years old) with aggressive B-cell lymphoma (namely, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade II) with aaIPI 2 and namely, with aaIPI 3. This study was aimed to find out if addition of four to six doses of Rituximab 375 mg/m2 on first day of every cycle of intensive induction further improves prognosis of these patients.~Inclusion criteria for this trial were:~newly diagnosed aggressive B-cell lymphoma, namely diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade III~age 18-65 years~age adjusted IPI (International Prognostic Index) score 2 or 3~ECOG performance status 0-3~signed informed consent~Exclusion criteria were:~relapsed lymphoma~previous treatment (up to one cycle of standard pretreatment - COP, CHOP or steroids was permitted and later became mandatory to decrease disease burden and/or improve the performance status of the patient)~Burkitt lymphoma~posttransplant lymphoproliferation~CNS involvement~other malignant tumor in previous history, except basalioma, skin squamocellular carcinoma or cervical carcinoma in situ~other serious comorbidity~Primary endpoints was progression-free survival~Secondary endpoints were:~rate of complete remission and overall response rate~overall survival~toxicity of the protocol, measured as grade III-IV toxicity and/or inability to finish the protocol as planned~Planned number of accrued patients was 100.
The purpose of this study is to show if addition of Rituximab to intensive induction (MegaCHOP/ESHAP) and high-dose consolidation (BEAM) improves progression-free and overall survival in patients younger than 65 years with aggressive B-cell lymphoma and aaIPI 2 or 3.