Status:
COMPLETED
Bendamustine Plus Rituximab Versus CHOP Plus Rituximab
Lead Sponsor:
University of Giessen
Conditions:
Non-Hodgkin Lymphomas
Follicular Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities:
- Follicular lymphoma grade 1 and 2
- Immunocytoma and lymphoplasmocytic lymphoma
- Marginal zone lymphoma, nodal and generalised
- Mantle cell lymphoma
- lymphocytic lymphoma (CLL without leucaemic characteristics)
- non-specified/classified lymphomas of low malignancy
- No prior therapy with cytotoxics,interferon or monoclonal antibodies
- Need for therapy, except mantle cell lymphomas
- Stadium III or IV
- Written informed consent
- Performance status WHO 0-2
- Histology not older than 6 months
Exclusion
- Patients not establishing all above mentioned prerequisites
- Option of a primary, potential curative radiation therapy
- Pretreatment except a unique local delimited radiation (radiation fiel not expanding two adjacent lymph node regions
- Comorbidities excluding a study conform therapy:
- heart attack during the last 6 months
- severe, medicinal not adjustable hypertonia
- severe functional defects of the heart (NYHA III or IV)
- lung (WHO grade III or IV), liver or kidney (creatinine \> 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
549 Patients enrolled
Trial Details
Trial ID
NCT00991211
Start Date
January 1 2004
End Date
August 1 2009
Last Update
August 22 2024
Active Locations (1)
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1
StiL Head Office; Justus-Liebig-University
Giessen, Germany, 35392