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

Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma: a Phase II Multicenter Study of the Fondazione Italiana Linfomi (FIL)

The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as frail according to CGA.

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