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

A Randomized Phase III Study Comparing CHOP Versus CEOP-induced Cardiotoxicity in Patients With Aggressive B-cell Lymphoma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00854568

Enrollment

398

Registered

2009-03-03

Start date

2009-03-31

Completion date

2013-02-28

Last updated

2014-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

B-cell lymphoma, CHOP, CEOP, Cardiotoxicity

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.

Interventions

DRUGCEOP regimen

cyclophosphamide 750mg/m2 IV day 1 epirubicin 70mg/m2 IV day 1 vincristine 1.4mg/m2 IV day1 (maximum: 2mg) prednisone 50mg PO days 1\ 5 twice per day Or combined with rituximab 375mg/m2 IV day 0

DRUGCHOP regimen

cyclophosphamide 750mg/m2 IV day 1 doxorubicin 50mg/m2 IV day 1 vincristine 1.4mg/m2 IV day1 (maximum: 2mg) prednisone 50mg PO days 1\ 5 twice per day Or combined with rituximab 375mg/m2 IV day 0

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Objective response rate	Six weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026