Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
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).
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.
Inclusion Criteria:
Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities:
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: