Clinical trial · Interventional
Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma
A Phase I Trial of BBR 2778 in Combination With Fludarabine, Dexamethasone and Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
NCT00060684CI-TRIAL-00016646completedPhase 1ClinicalTrials.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 aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combination's safety and activity profile.
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, 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 |
| Lymphoma, Small Lymphocytic | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| fludarabine | Drug | Fludarabine | ALIAS |
| Pixantrone (BBR 2778) | Drug | Pixantrone | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine MTD
- timeFrame
- Per cycle
Secondary outcomes (1)
- measure
- Establish safety profile
- timeFrame
- per cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Patients with relapsed or refractory indolent (low-grade) NHL * Who have received 1-3 prior treatments with chemotherapy Exclusion criteria * Patients previously treated with fludarabine * Prior treatment with rituximab (Rituxan), unless there was a complete response (CR) or partial response (PR) to that treatment * Patients known to have an allergic reaction to rituximab, or to murine proteins.
References
Publications (1)
- RESULTSrokowski TP, Liebmann JE, Modiano MR, Cohen GI, Pro B, Romaguera JE, Kuepfer C, Singer JW, Fayad LE. Pixantrone dimaleate in combination with fludarabine, dexamethasone, and rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: phase 1 study with a dose-expansion cohort. Cancer. 2011 Nov 15;117(22):5067-73. doi: 10.1002/cncr.26121. Epub 2011 Jun 16. PMID 21681734