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Advanced Follicular Lymphoma Evaluating the Benefit of Maintenance Therapy With Rituximab (MabThera®) After Induction of Response With Chemotherapy Plus Rituximab in Comparison With no Maintenance Therapy
* 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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
December 1, 2004
Primary Completion Date
May 1, 2007
Completion Date
December 1, 2016
Last Updated
March 13, 2017
1,217
ACTUAL participants
Rituximab
DRUG
Lead Sponsor
Lymphoma Study Association
Collaborators
NCT06337318
NCT05006716
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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