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

University of Magdeburg

Status and phase

Unknown

Phase 2

Conditions

Lymphoma, High-Grade

Treatments

Drug: Bendamustine

Drug: Rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00385125

OSHO #73

Details and patient eligibility

About

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)