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

Phase 3 Completed 140 enrolled CTI BioPharma

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2004-07
Primary completion: 2010-02
Completion: 2010-07

Outcome

Met primary endpoint

paper achieved a complete or unconfirmed complete response at end of treatment compared with four patients (5·7% [1·6-14·0]) in the comparator group (p = 0·021). PMID 22652183 ↗

Publications

Pettengell R, Coiffier B, Narayanan G, de Mendoza FH, Digumarti R, Gomez H, Zinzani PL, Schiller G, Rizzieri D, Boland G, Cernohous P, Wang L, Kuepfer C, Gorbatchevsky I, Singer JW. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial. Lancet Oncol. 2012 Jul;13(7):696-706. doi: 10.1016/S1470-2045(12)70212-7. Epub 2012 May 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Etoposide	Small molecule	—	—
Comparator	Gemcitabine	Small molecule	—	—
Comparator	Ifosfamide	Small molecule	—	—
Comparator	Mitoxantrone	Small molecule	—	—
Comparator	Oxaliplatin	Small molecule	—	—
Subject	Pixantrone	Small molecule	150 mg/m2	Intravenous
Subject	Rituximab	Monoclonal antibody	375 mg/m2	—
Comparator	Vinorelbine	Small molecule	—	—
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	—
Background	Prednisone	Other / unclassified	100 mg	—
Background	Vincristine	Small molecule	1.4 mg/m2	—