Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL

Study Overview
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Brief Summary
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Phase II study for treatment of patients with relapsed or primary refractory aggressive B- cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for autologous stem cell transplantation.

Detailed Description
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Phase II study for treatment of patients with relapsed or primary refractory aggressive B- cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for autologous stem cell transplantation. Aim is to find response rates and duration of combination chemotherapy (bendamustine/rituximab) in patients with relapsed or refractory CD 20 positive B cell NHL.

Official Title
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Phase II Study for Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL and Anthracycline Chemotherapy Pretreatment, Who Received or Did Not Qualify for Autologous Stem Cell Transplantation.

Conditions
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Lymphoma, High-Grade

Intervention / Treatment
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* Drug: Bendamustine
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven high grade B-NHL (CD 20 >= 20 % positive) Age >= 18 years At least one pretreatment with anthracycline polychemotherapy +/- radiatio: first relapse nad contraindication for aggressive salvage therapy e.g. high dose therapy with autologous stem cell transplantation second relapse (after aggressive salvage therapy) patient's refusal of aggressive salvage therapy in first relapse informed consent Exclusion Criteria: untreated patients pretreatment with bendamustine primary CNS- lymphoma Karnofsky index < 50 (except caused by lymphoma) HIV positive, hepatitis B or C serious concurrent disease non-compensated heart failure (>=NYHA 3) non-compensated hypertension renal insufficiency (creatinine > 2.0 mg/dl), not related to lymphoma hepatic insufficiency with transaminase values greater than 3-fold of normal values and/or bilirubin levels > 200 µmol/l, not related to lymphoma missing compliance respective incapability to comply (e.g.cerebral dysfunction pregnancy hematopoetic insufficiency not lymphoma related (leucocyte count <= 2500/µl, granulocyte count <= 1000/µl, platelet count <= 80000/µl)

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bendamustine|nan|
|Drug: Rituximab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  |  | 
| response duration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 
| toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsed, refractory, CD 20 positive