NCT00991211

Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 549 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS).

Detailed description

The 4 agent chemotherapy (CTX) CHOP (cyclophosphamide, doxorubicin, vincristine prednisone) in combination with the monoclonal anti-CD20 antibody rituximab (CHOP-R) represents a standard CTX for the treatment of lymphomas of high or low malignancy. The combination of bendamustine and rituximab (B-R) is also highly effective with a more advantageous toxicity profile. If B-R could be shown to be non inferior to CHOP-R, this could improve the quality of life of the patient and possibly also the prognosis.

Conditions

• Non-Hodgkin Lymphomas
• Follicular Lymphomas
• Immunocytomas
• Lymphocytic Lymphomas
• Marginal Zone Lymphomas

Interventions

Type	Name	Description
DRUG	Bendamustine	Comparison of Bendamustine + Rituximab with CHOP + Rituximab
DRUG	Standard chemotherapy CHOP + Ritiximab	Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w as standard Chemotherapy

Timeline

• Start date: 2004-01-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-10-07
• Last updated: 2024-08-22

Locations

1 site across 1 country: Germany