NCT00088530

BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The primary study objective is to compare the efficacy of BBR 2778 to a selection of single agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a selection of single agents, and to assess the pharmacokinetic parameters of BBR 2778 in a subset of this patient population.

Conditions

• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	pixantrone, cyclophosphamide, vincristine, rituximab, prednisone	Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
DRUG	Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab	Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)

Timeline

• Start date: 2004-07-01
• Primary completion: 2010-02-01
• Completion: 2010-07-01
• First posted: 2004-07-29
• Last updated: 2020-02-05
• Results posted: 2017-06-01

Locations

99 sites across 20 countries: United States, Argentina, Bulgaria, Costa Rica, Ecuador, Estonia, France, Germany, Hungary, India, Italy, Mexico, Panama, Peru, Poland, Romania, Russia, Ukraine, United Kingdom, Uruguay