R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas

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.

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.