* Objectives * Primary objective: To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy * Secondary objective: To evaluate response rates, event driven survival endpoints (EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab, for first line treatment of advanced stage follicular lymphoma. * Study Design This is an international open-label, multicentre, randomized study with two treatment phases. In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation. After the maintenance period patients will be included in the follow up phase for 3 years.
Study medication * First period: Induction of response with 8 x rituximab combined with 8 cycles of CVP or 6 cycles of CHOP in 21-day cycles or 6 cycles of FCM in 28-day cycles or 6 cycles of MCP in 28-day cycles. * Second period: rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,217
rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment
Fundaleu Hospital
Buenos Aires, Argentina
Australian Leukemia and Lymphoma Group
Melbourne, Australia
Université de Gent
Ghent, Belgium
Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, Belgium
Hospital Samaritano
São Paulo, Brazil
Fundación Santafé de Bogotá
Bogotá, Colombia
Amtssygehuset i Herlev
Herlev, Denmark
Polyclinique Bordeaux Nord
Bordeaux, France
Hôpital Henri Mondor
Créteil, France
Hématologie CHU de Lille
Lille, France
...and 14 more locations
Progression Free Survival (PFS)
defined as the time from randomization to progression, relapse, death from any cause.
Time frame: number of event observed driven : 344 events or 10 years
Response rates, event driven survival endpoints (EFS, PFS, OS)
Time frame: number of event observed driven : 344 events or 10 years
Quality of life
Time frame: number of event observed driven : 344 events or 10 years
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