Bendamustine is a well tolerable and very active agent in the treatment of Non Hodgkin's lymphoma. However, in particular in aggressive B-cell lymphoma, only very few, small studies have investigated the role of bendamustine in the treatment algorithm. The aim of the current B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment of bendamustine and subcutaneous rituximab in old patients or in elderly patients with high comorbidity who do not qualify for a CHOP like treatment. The results of this study will form the basis of a larger, prospective randomized phase III trial.
Bendamustine is a well tolerable and very active agent in the treatment of Non Hodgkin's lymphoma. However, in particular in aggressive B-cell lymphoma, only very few, small studies have investigated the role of bendamustine in the treatment algorithm. The aim of the current B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment of bendamustine and subcutaneous rituximab in old patients or in elderly patients with high comorbidity who do not qualify for a CHOP like treatment. The results of this study will form the basis of a larger, prospective randomized phase III trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Prof. Trümper
Göttingen, Germany
Progression-free survival
Time frame: 2 years
adverse events (AE)'s
Time frame: up to 30 days after last study drug administration
serious adverse events (SAE)'s
Time frame: up to 30 days after last study drug administration
rate of therapy-associated deaths
Time frame: up to 30 days after last study drug administration
protocol adherence
Time frame: 18 weeks after start of therapy
CR rate
Time frame: 2 years
PR rate
Time frame: 2 years
rate of primary progression
Time frame: 2 years
relapse rate
Time frame: 2 years
event-free survival
Time frame: 2 years
overall survival
Time frame: 2 years
Quality of life
Time frame: 2 years
Comprehensive Geriatric Assessment
Time frame: 2 years
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