NCT01456351

Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

Prospective Randomised Multicenter Study for Therapy Optimization of Recurrent, Progressive Low Grade Non-Hodgkin Lymphomas and Mantle Cell Lymphomas

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study addresses the question if a therapy with bendamustine plus rituximab is comparable (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.

Conditions

• Non-Hodgkin's Lymphoma
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine plus Rituximab	Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles
DRUG	Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w	Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles

Timeline

• Start date: 2003-09-01
• Primary completion: 2010-08-01
• Completion: 2010-12-01
• First posted: 2011-10-20
• Last updated: 2024-08-22

Locations

1 site across 1 country: Germany