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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Induction phase: rituximab and 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
ZNA Stuivenberg
Antwerp, Belgium
Clinique Sud du Luxembourg
Arlon, Belgium
RHMS
Baudour, Belgium
A. Z. Sint-Jan
Bruges, Belgium
CHU Brugmann
Brussels, Belgium
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Belgium
Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine
Time frame: 12 weeks
Complete response rate according to Cheson criteria 1999 after 24 months of maintenance therapy with Rituximab
Time frame: 26 months
Partial and objective response rates at the end of induction phase
Time frame: 12 weeks
Duration of response
Time frame: From the time of attainment of CR or PR to the date of first documented disease progression, relapse or death from any cause
Progression free survival
Time frame: From the date of randomization to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause.
Overall survival
Time frame: From the date of randomization to the date of death from any cause
Time before retreatment
Time frame: From the end of primary treatment until the institution of the next therapy
Immediate toxicity
Time frame: 12 weeks
Long term toxicity
Time frame: Until death of the patients
Evaluation of QoL
Time frame: 7 years
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Université Catholique de Louvain Saint Luc
Brussels, Belgium
CH Notre Dame
Charleroi, Belgium
CHU Charleroi-Vésale
Charleroi, Belgium
Centre de Santé des Fagnes
Chimay, Belgium
...and 107 more locations