Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
18 Years
N/A
Both
Non-Hodgkin Lymphomas, Follicular Lymphomas, Immunocytomas, Lymphocytic Lymphomas, Marginal Zone Lymphomas
Trial Information
Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
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.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Time Frame:
observation 3 years or significant differences between two arms
Safety Issue:
Yes
Principal Investigator
Mathias Rummel, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Study Group of indolent Lymphom,as (StiL)
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
NHL 1-2003
NCT ID:
NCT00991211
Start Date:
January 2004
Completion Date:
August 2009
Related Keywords:
- Non-Hodgkin Lymphomas
- Follicular Lymphomas
- Immunocytomas
- Lymphocytic Lymphomas
- Marginal Zone Lymphomas
- Comparison
- Bendamustine + Rituximab
- CHOP + Rituximab
- Progression free survival
- Overall survival
- Toxicity
- Safety
- Leukemia, Lymphocytic, Chronic, B-Cell
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell, Marginal Zone
- Lymphoma, Mantle-Cell
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