Clinical trial NCT01313611 (phase 2, status: terminated)
Conditions: follicular lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: rituximab + bendamustine
SMILES: CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl
Reason stopped: 
    treament with rituximab during maintenance phase was stoped, according to dsmc recommendations,
    since 3 cases of deaths occured.
  
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.