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

• Status: Unknown status
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Magdeburg
• Treatments: Bendamustine Hydrochloride; Rituximab

Criteria

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)