Initial diagnosis of histologically confirmed follicular lymphoma MedDRA version: 14.1 Level: HLT Classification code 10016903 Term: Follicle centre lymphomas, follicular grade I, II, III System Organ Class: 100000004851
Conditions
Interventions
Trade Name: LEVACT
Product Name: bendamustine
Pharmaceutical Form: Powder for solution for infusion
Trade Name: MABTHERA
Product Name: rituximab
Pharmaceutical Form: Powder for solution for infusion
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Inclusion 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 et CD5 • Age must be = 60 years. • Patients not previously treated. • Patients with an intermediate or high risk FLIPI score requiring with one or more of the following adverse prognostic factors: 1. Ann Arbor Stage (I-II vs. III-IV) 2. Hemoglobin level ( 50 ml/min (according to MDRD method) unless these abnormalities are related to lymphoma • Adequate hepatic function: Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 • 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 • Known HIV infection or active HBV or HCV infection • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the complete response rate according to Cheson criteria 1999 after a short induction treatment by Rituximab and Bendamustine in 1st line follicular lymphoma patients, = 60 years old, with an intermediate or high FLIPI score, and without high tumor burden (according to GELF criteria);Secondary Objective: - Complete response rate at the end of induction according to Cheson 2007 - Overall response rates at the end of induction phase - Overall response rate at the end of induction phase according to Cheson 2007 - Response rates at the end of maintenance phase according to Cheson 1999 - Response rates at the end of maintenance phase according toCheson 2007 - Duration of response - Progression free survival - Overall survival - Time to next anti lymphoma treatment - Immediate toxicity (grades 3 and 4, during the twelve first weeks) - Long-term toxicity - QoL evaluation ;Primary end point(s): To evaluate the response rate after a short treatment by rituximab and bendamustine instead of a watch-and-wait approach.;Timepoint(s) of evaluation of this end point: After the completion of the induction phase for all the 62 included patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Complete response rate at the end of induction according to Cheson 2007 - Overall response rates at the end of induction phase according to Cheson 1999 - Overall response rate at the end of induction phase according to Cheson 2007 - Response rates at the end of maintenance phase according to Cheson 1999 - Response rates at the end of maintenance phase according toCheson 2007 - Duration of response - Progression free survival - Overall survival - Time to next anti lymphoma treatment - Immediate toxicity (grades 3 and 4, during the twelve first weeks) - Long-term toxicity - QoL evaluation ;Timepoint(s) of evaluation of this end point: - After the completion of the induction phase for all the 62 included patients - After the completion of the maintenance phase for all the 62 included patients | — |
Countries
Belgium
Contacts
Public ContactChairman of the study
Professor Pierre Feugier
Outcome results
None listed