Trials / Completed
CompletedNCT01686321
Rituximab and Bendamustine in Very Elderly Patients or Elderly Medically Non Fit Patients With Aggressive B-cell Lymphoma
Subcutaneous Rituximab and Intravenous Bendamustine in Very Elderly Patients or Elderly Medically Non Fit Patients ("Slow Go") With Aggressive CD20-positive B-cell
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- University of Göttingen · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bendamustine and subcutaneous rituximab |
Timeline
- Start date
- 2012-07-04
- Primary completion
- 2018-08-08
- Completion
- 2018-08-08
- First posted
- 2012-09-18
- Last updated
- 2018-12-31
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01686321. Inclusion in this directory is not an endorsement.