Rituximab and Bendamustine in Very Elderly Patients or Elderly Medically Non Fit Patients With Aggressive B-cell Lymphoma
- Sponsor
- University of Göttingen
- Study ID
- NCT01686321
- Phase
- PHASE2
- Status
- Completed
Conditions
- Aggressive Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
Study Details
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.
Key Dates
- Start date
- Jul 4, 2012
- Status verified
- Dec 2018
- Primary completion
- Aug 8, 2018
- Completion
- Aug 8, 2018
Study Design
- Enrollment
- 68 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Bendamustine and subcutaneous Rituximabsingle-arm non randomized
Primary Outcome Measure
Progression-free survival [ Time Frame: 2 years ]