NCT01990144

Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL

Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma: a Phase II Multicenter Study of the Fondazione Italiana Linfomi (FIL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as frail according to CGA.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine+Rituximab	Patients will receive : * Rituximab 375 mg/m2 intravenously on day 1\* * Bendamustine 90 mg/m2 intravenously on days 2 and 3\*\* Treatment will be administered on a 28-day cycle basis. * Administration of rituximab during cycle 1 is postponed to day 8, thereafter on day 1. * After the first cycle, bendamustine can be administered on days 1-2 or days 2-3 according to Institutional/patient/physician choice.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-02-01
• Completion: 2016-02-01
• First posted: 2013-11-21
• Last updated: 2013-11-21

Locations

52 sites across 1 country: Italy