Follicular Lymphomas, Immunocytomas, Lymphocytic Lymphomas, Marginal Zone Lymphomas, Non-Hodgkin Lymphomas
Conditions
Keywords
Comparison, Bendamustine + Rituximab, CHOP + Rituximab, Progression free survival, Overall survival, Toxicity, Safety
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 to progression free survival (PFS).
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 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.
Interventions
DRUGBendamustine
Comparison of Bendamustine + Rituximab with CHOP + Rituximab
DRUGStandard chemotherapy CHOP + Ritiximab
Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w as standard Chemotherapy
Sponsors
University of Giessen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | observation 3 years or significant differences between two arms |
Secondary
| Measure | Time frame |
|---|---|
| Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization | ongoing |
Countries
Germany
Outcome results
None listed