Clinical trial · Interventional
Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma
An Open-Label, Randomized, Phase III Comparative Trial of BBR 2778 + Rituximab Versus Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NHL)
NCT00060671CI-TRIAL-00016653terminatedPhase 3ClinicalTrials.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)
The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name pending) with the monoclonal antibody rituximab, leads to an increase in the period of patients' remission, compared to rituximab alone.
Conditions
Conditions (4)
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, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Low-Grade | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Mixed-Cell, Follicular | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Small Cleaved-Cell, Follicular | Grade 1 Follicular Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pixantrone (BBR 2778) | Drug | Pixantrone | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Compare the time to tumor progression (TTP) of the combination of BBR 2778 (pixantrone) + rituximab with that of rituximab alone
- timeFrame
- For 5 years post treatment
Secondary outcomes (1)
- measure
- To compare BBR 2778 + rituximab versus rituximab for:
- timeFrame
- For 5 years post treatment
- description
- * objective overall response rate (ORR; CR + PR) * objective complete response rate (CRR) * rate of molecular remission * time to response * time to complete response * duration of response * Time to Tumor Progression requiring treatment * Quality-Adjusted Time To Progression (QATTP) * overall survival * disease-specific survival * safety/tolerability
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL), including follicular lymphoma grade I and II * Presenting with an episode of progressive disease, following 1-5 prior treatments (with either radiation, chemotherapy or rituximab). Exclusion criteria: * Patients that failed to respond to previous rituximab treatment, or relapsed within 6 months of the first rituximab infusion * Patients known to have an allergic reaction to rituximab or murine derived proteins.
References
Publications (1)
- RESULTSantoro A; Voglova J; Gabrail N; Ciuleanu T; Liberati M; Hancock BW; Stromatt S; Caballero D; Comparative Trial of Pixantrone + Rituximab vs Single agent Rituximab in the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma; American Society of Clinical Oncology abstract and poster; Part 1, Vol 24 No 18S, June 20 supplement, 2006: 7578