Clinical Trials (PDQ®)
|Phase III||Treatment||Completed||18 and over||Other||NHL 1-2003|
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 to progression free survival (PFS).
Further Study Information
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 treatment of lymphomas of high or low malignancy. The combination of bendamustine and rituximab (B-R) is also highly effective with a more advantageous toxicity profile. If B-R could be shown to be non inferior to CHOP-R, this could improve the quality of life of the patient and possibly also the prognosis.
- 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
- 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.
Trial Lead Organizations/Sponsors
Universitaetsklinikum Giessen und Marburg GmbH - Giessen
|Mathias Rummel, Dr.||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00991211
ClinicalTrials.gov processed this data on October 20, 2014
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