r-megachop-eshap-beam in patients with high-risk aggressive b-cell lymphomas

Conditions: Diffuse Large B-Cell Lymphoma.; Primary Mediastinal B-Cell Lymphoma; Follicular Lymphoma Grade III

Summary: 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.

Eligibility criteria:
inclusion criteria: * aggressive b-cell lymphoma, namely diffuse large b-cell lymphoma, primary mediastinal b-cell lymphoma, follicular lymphoma grade iii * age 18-65 years * age-adjusted ipi score 2-3 * ecog performance status 0-3 * signed informed consent exclusion criteria: * burkitt lymphoma * posttransplant lymphoproliferation * previous treatment (up to one cycle of standard pretreatment with cop, chop or steroids permitted and latter mandatory to decrease tumor burden and/or improve performance status) * other tumor in previous history with the exception of basalioma, squamous cell carcinoma of the skin or cervical carcinoma in situ * pregnancy/lactation * cns involvement * other serious comorbidities

Keywords: lymphoma, b-cell immunotherapy, passive remission induction autologous transplantation