drugset / Trial / NCT00577161
Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
RandomizedParallel-groupSingle-blindTreatment
Summary
BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and reduced delayed cardiotoxicity in animal models compared to reference standards. This cytotoxic agent has structural similarities to mitoxantrone as well as general similarities to anthracyclines (such as the tricyclic central quinoid chromophore7). This phase III study will compare the efficacy and safety of the combination BBR 2778, fludarabine, and rituximab with the combination fludarabine and rituximab in patients with relapsed or refractory indolent non-Hodgkin's lymphoma.
Timeline
- Start
- 2007-09
- Primary completion
- 2012-07
- Completion
- 2012-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pixantrone | Small molecule | 120 mg/m2 | — |
| Comparator | Fludarabine | Small molecule | 25 mg/m2 | — |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | — |