Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas

Conditions
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Non-Hodgkin Lymphomas, Follicular Lymphomas, Immunocytomas, Lymphocytic Lymphomas, Marginal Zone Lymphomas

Intervention / Treatment
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* Drug: Bendamustine
* Drug: Standard chemotherapy CHOP + Ritiximab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bendamustine + Rituximab<br>Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w | Drug: Bendamustine<br>* Comparison of Bendamustine + Rituximab with CHOP + Rituximab<br>* Other names: Ribomustin, Treanda;|
| Active Comparator: CHOP + Rituximab<br>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 | Drug: Standard chemotherapy CHOP + Ritiximab<br>* 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<br>* Other names: Rituxan(R), MabThera(R) = Rituximab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | observation 3 years or significant differences between two arms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization |  | ongoing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comparison, Bendamustine + Rituximab, CHOP + Rituximab, Progression free survival, Overall survival, Toxicity, Safety