BRIEF Bendamustine and Rituximab In Elderly Follicular

Summary

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

Timeline

Start

2011-02

Primary completion

2012-10

Completion

2017-12

Outcome

Outcome not reported

Stopped: “Treament with rituximab during maintenance phase was stoped, according to DSMC recommendations, since 3 cases of deaths occured.”

Publications

• Gyan E, Sonet A, Brice P, Anglaret B, Laribi K, Fruchart C, Tilly H, Araujo C, Soubeyran P, Gonzalez H, Morineau N, Nicolas-Virelizier E, Ghesquieres H, Salles B, Bouabdallah R, Orfeuvre H, Fahri J, Couturier O, Xerri L, Feugier P; Lymphoma Study Association (LYSA). Bendamustine and rituximab in elderly patients with low-tumour burden follicular lymphoma. Results of the LYSA phase II BRIEF study. Br J Haematol. 2018 Oct;183(1):76-86. doi: 10.1111/bjh.15513. Epub 2018 Aug 16.

Drugs

Indications