Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
observation 3 years or significant differences between two arms
Mathias Rummel, Dr.
Study Group of indolent Lymphom,as (StiL)
Germany: Federal Institute for Drugs and Medical Devices