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