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Rituximab and Bendamustine in Very Elderly Patients or Elderly Medically Non Fit Patients With Aggressive B-cell Lymphoma

NCT01686321 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2018-12-31

No results posted yet for this study

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.

Conditions

  • Aggressive Lymphoma

Interventions

DRUG

Bendamustine and subcutaneous rituximab

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Mundipharma Research GmbH & Co KG

    collaborator INDUSTRY

  • University of Göttingen

    lead OTHER

Principal Investigators

  • Lorenz Trümper, Prof · University medicine Goettingen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-04
Primary Completion
2018-08-08
Completion
2018-08-08

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01686321 on ClinicalTrials.gov