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Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial
BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).
Details
| Lead sponsor | CTI BioPharma |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 140 |
| Start date | 2004-07 |
| Completion | 2010-07 |
Conditions
- Lymphoma, Non-Hodgkin
Interventions
- pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
- Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Primary outcomes
- Complete Response (CR) and Complete Response Unconfirmed (CRu) — EOT; approximately 6 months
Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT)
Countries
United States, Argentina, Bulgaria, Costa Rica, Ecuador, Estonia, France, Germany, Hungary, India, Italy, Mexico, Panama, Peru, Poland, Romania, Russia, Ukraine, United Kingdom, Uruguay