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

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.

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.

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.

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)