Status:
UNKNOWN
Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL
Lead Sponsor:
University of Magdeburg
Conditions:
Lymphoma, High-Grade
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 cel...
Detailed 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 cel...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00385125
Start Date
August 1 2004
End Date
August 1 2010
Last Update
October 6 2006
Active Locations (1)
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1
University of Magdeburg, departement of Hematology and Oncology
Magdeburg, Germany, 39120