A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin

Phase 2 Completed 124 enrolled CTI BioPharma

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.

Timeline

Start: 2005-11
Primary completion: 2012-05
Completion: 2012-05

Publications

Results Herbrecht R, Cernohous P, Engert A, Le Gouill S, Macdonald D, Machida C, Myint H, Saleh A, Singer J, Wilhelm M, van der Jagt R. Comparison of pixantrone-based regimen (CPOP-R) with doxorubicin-based therapy (CHOP-R) for treatment of diffuse large B-cell lymphoma. Ann Oncol. 2013 Oct;24(10):2618-2623. doi: 10.1093/annonc/mdt289. Epub 2013 Aug 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Doxorubicin	Other / unclassified	50 mg/m2	—
Subject	Pixantrone	Small molecule	150 mg/m2	—
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	—
Background	Prednisone	Other / unclassified	100 mg	—
Background	Rituximab	Monoclonal antibody	375 mg/m2	—
Background	Vincristine	Small molecule	1.4 mg/m2	—

A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin

Summary

Timeline

Publications

Drugs

Indications