Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Giessen
• Treatments: Bendamustine Hydrochloride; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities:

• Follicular lymphoma grade 1 and 2

• Immunocytoma and lymphoplasmocytic lymphoma

• Marginal zone lymphoma, nodal and generalised

• Mantle cell lymphoma

• lymphocytic lymphoma (CLL without leucaemic characteristics)

• non-specified/classified lymphomas of low malignancy

• No prior therapy with cytotoxics,interferon or monoclonal antibodies

• Need for therapy, except mantle cell lymphomas

• Stadium III or IV

• Written informed consent

• Performance status WHO 0-2

• Histology not older than 6 months

Exclusion Criteria:

• Patients not establishing all above mentioned prerequisites

• Option of a primary, potential curative radiation therapy

• Pretreatment except a unique local delimited radiation (radiation fiel not expanding two adjacent lymph node regions

• Comorbidities excluding a study conform therapy:

• heart attack during the last 6 months

• severe, medicinal not adjustable hypertonia

• severe functional defects of the heart (NYHA III or IV)

• lung (WHO grade III or IV), liver or kidney (creatinine > 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma.