The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.
Results from several randomised studies show a clinical benefit of a maintenance therapy with rituximab in follicular lymphomas. The advantage of a maintenance therapy in other indolent and mantle cell lymphomas is - due to the lower incidence of these diseases- not well investigated. This study tries to determine the significance of an extended maintenance therapy with rituximab in follicular lymphomas and the significance of a maintenance therapy other indolent and mantle cell lymphomas compared to observation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,272
Follicular Lymphomas: induction therapy with bendamustine + rituximab. If CR or PR: Maintenance therapy with rituximab every 2 months for 4 years Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years
Follicular Lymphomas:induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years (standard) Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: observation (standard)
StiL Head Office; Justus-Liebig-University
Giessen, Germany
Progression free survival
Time from randomization until progress or death of any course
Time frame: 5 years and ongoing
Remission rate and duration; event free-, progression free-, disease free- and over all survival
Time from randomization until treatment failure due to progression or not achieving any remission; time from achievin CR or PR until progression or relapse
Time frame: 5 years and ongoing
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