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Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) vs Fludarabine and Rituximab (F-R) for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
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.
Details
| Lead sponsor | CTI BioPharma |
|---|---|
| Phase | Phase 3 |
| Status | WITHDRAWN |
| Start date | 2007-09 |
| Completion | 2012-07 |
Conditions
- Non-Hodgkin's Lymphoma
Interventions
- fludarabine and rituximab
- fludarabine, rituximab, pixantrone
Primary outcomes
- progression-free survival — day 64-71
Countries
United States