BRIEF Bendamustine and Rituximab In Elderly Follicular

The Lymphoma Academic Research Organisation

Status and phase

Terminated

Phase 2

Conditions

Follicular Lymphoma

Treatments

Drug: Rituximab + bendamustine

Study type

Interventional

Funder types

Other

Identifiers

NCT01313611

BRIEF

Details and patient eligibility

About

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

Enrollment

62 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.