Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL

Inclusion Criteria: * Histologically proven CD20 positive diffuse large B-cell non-Hodgkin's lymphoma * Age \> 70 years * No previous treatment * FRAIL patients defined as follows (see Appendices B-E) Age \> 80 years with UNFIT profile, i.e. * ADL \> 5 residual functions * IADL \> 6 residual functions * CIRS 5-8 co-morbidities of grade 2 or Age \< 80 years with * ADL \< 4 residual functions, or * IADL \< 5 residual functions, or * CIRS : 1 co-morbidity of grade 3-4, or \> 8 co-morbidities of grade 2 * Life expectancy \> 6 months * Written informed consent * Accessibility of patient for treatment and follow up Exclusion Criteria: * History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer * Previous exposure to cytotoxic agents * Suspect or clinical evidence of CNS involvement by lymphoma * HBsAg, HCV or HIV positivity; HBcAb positivity is accepted only with concomitant treatment with Lamivudine * AST /ALT \> twice upper the normal range; bilirubin \> twice upper the normal range; serum creatinine \> 2.5 mg /dl * Evidence of any severe active acute or chronic infection * Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy * Senile dementia * Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent