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

Phase 3

Completed

• Conditions: Lymphoma
• Interventions: Drug: CEOP regimen; Drug: CHOP regimen

• Registration Number: NCT00854568
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

The doxorucin-containing regimen (CHOP) and epirubicin-containing regimen (CEOP) are both frequently used in patients with aggress B-cell lymphoma in out institution. According to a Cochrane meta-analysis, epirubicin is less cardiotoxic than doxorubicin on a mg per mg basis. However, compared with 50mg/m2 of doxorubicin in CHOP, epirubicin was usually used at a higher dose (70mg/m2) to treat non-Hodgkin's lymphoma (NHL). Because of the correlation between cumulative dose and risk of cardiotoxicity, it is reasonable to speculate that CEOP (70mg/m2) has less cardiotoxicity than CHOP (50mg/m2) when both regimens are administered with similar cycles.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Study First Posted: 2009-03-03
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

Inclusion Criteria

• Previously untreated aggressive B-cell lymphoma
• Age range 18-75 years old
• ECOG performance status 0-2
• Life expectancy of more than 3 months
• Adequate organ function

Exclusion Criteria

• Previous serious cardiac disease
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Pregnant or lactating women
• Serious uncontrolled diseases and intercurrent infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CEOP regimen	CEOP regimen	CEOP regimen
CHOP regimen	CHOP regimen	CHOP regimen

Primary Outcome Measures

Name	Time	Method
Cardiotoxicity (Class III or IV cardiotoxicity according to New York Heart Association (NYHA) Classification or LVEF abnormality [< 50% or a decrease in absolute LVEF ≥ 10%) by post-treatment RNA])	18 weeks

Secondary Outcome Measures

Name	Time	Method
Objective response rate	Six weeks

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China