BRIEF Bendamustine and Rituximab In Elderly Follicular

Inclusion Criteria

• •Histologically confirmed follicular lymphoma CD20+, all grades except the grade 3b with a lymph node biopsy performed within 6 months before study entry and with material available for central review
• •A minimal initial immunology is required, including : CD20, bcl-2, CD10 and CD5
• •Age must be ≥ 60 years
• •Patients not previously treated
• •Patients with an intermediate or high risk FLIPI score requiring 2 or more of the following adverse prognostic factors:
• •1. Age \>60 ans
• •2. Ann Arbor Stage (III-IV vs. I-II)
• •3. Hemoglobin level ( \< 12g/dL vs. ≥ 12 g/dL)
• •4. Number of nodal areas (\< 5 vs. ≥ 5) (Note: LDH should not be considered as an adverse prognostic factor in this study since it is considered as high tumor burden in the GELF criteria)
• •Low burden disease at study entry according to the GELF criteria
• •Patients with at least one measurable site of disease: patients with only blood or marrow or splenic infiltration are excluded
• •Performance status ≤ 2 on the ECOG scale
• •Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) including:
• •Hemoglobin ≥ 8.0 g/dL (5.0 mmol/L)
• •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• •Platelet count ≥ 100 x 109/L
• •Adequate renal function: calculated creatinine clearance \> 50 ml/min (according to MDRD method) unless these abnormalities are related to lymphoma
• •Adequate hepatic function: Total bilirubin \< 2.0 mg/dl (34 µmol/L), AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal unless these abnormalities are related to lymphoma
• •Adequate cardiac function: LEVF ≥ 50% calculated by echocardiography or scintigraphy
• •Having previously signed a written informed consent