Clinical trial · Interventional
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.
NCT00385125CI-TRIAL-00000466unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, High-Grade | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- response rate
- measure
- response duration
Secondary outcomes (2)
- measure
- overall survival
- measure
- toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.