brief bendamustine and rituximab in elderly follicular

Conditions: Follicular Lymphoma

Summary: the objective of this study is to evaluate the complete response rate after a short induction treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in in elderly (≥ 60 years old) patients with untreated follicular lymphoma, with an intermediate or high flipi score and without high tumor burden. this short induction is followed by a rituximab (375mg/m2)maintenance/ induction schedule:rituximab+bendamustine on day 1, bendamustine on day 2, rituximab on day 8, rituximab on day 15, rituximab on day 22, bendamustine on day 29, bendamustine on day 30 maintenance schedule: 12 infusions of rituximab, each 8 weeks


Eligibility criteria:
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 exclusion criteria: * other histological types of lymphoma than follicular lymphoma * grade 3b follicular lymphoma * patients previously on watch and wait since more than 6 months from diagnosis * patients previously treated for lymphoma, except splenectomy * patients with low flipi score (0 or 1 adverse prognostic factors not considering elevated ldh) * bulky disease at study entry according to the gelf criteria * presence or history of cns disease (either cns lymphoma or lymphomatous meningitis) * patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer or previous cancer in cr without any treatment in the last 5 years * positive hiv, hbv (anti-hbc positivity) and hcv serologies before inclusion * poor performance status \> 2 on the ecog scale * known contra-indication to study product * serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). * any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent.