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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: CEOP regimen
* Drug: CHOP regimen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEOP regimen<br>CEOP regimen | Drug: CEOP regimen<br>* 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<br>* Other names: CEOP;|
| Active Comparator: CHOP regimen<br>CHOP regimen | Drug: CHOP regimen<br>* 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<br>* Other names: CHOP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | Six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-cell lymphoma, CHOP, CEOP, Cardiotoxicity