drugset / Trial / NCT00854568

Comparison Study of Doxorubicin Versus Epirubicin-induced Cardiotoxicity in Patients With DLBCL

NCT00854568

Phase 3 Completed 398 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this study is to compare CHOP versus CEOP-induced cardiotoxicity in patients with aggressive B-cell lymphoma. The hypothesis is epirubicin is associated with less cardiotoxicity without compromising the efficacy.

Timeline

Start
2009-03
Primary completion
2012-12
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Subject Epirubicin Small molecule 70 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Comparator Prednisone Other / unclassified 50 mg Oral
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Comparator Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications