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

Primary Purpose

Lymphoma

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

CEOP regimen

CHOP regimen

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring B-cell lymphoma, CHOP, CEOP, Cardiotoxicity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CEOP regimen

CHOP regimen

Arm Description

CEOP regimen

CHOP regimen

Outcomes

Primary Outcome Measures

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])

Secondary Outcome Measures

Objective response rate

Full Information

NCT ID

NCT00854568

First Posted

March 2, 2009

Last Updated

August 19, 2014

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT00854568

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

B-cell lymphoma, CHOP, CEOP, Cardiotoxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

398 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CEOP regimen

Arm Type

Experimental

Arm Description

CEOP regimen

Arm Title

CHOP regimen

Arm Type

Active Comparator

Arm Description

CHOP regimen

Intervention Type

Drug

Intervention Name(s)

CEOP regimen

Other Intervention Name(s)

CEOP

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

CHOP regimen

Other Intervention Name(s)

CHOP

Intervention Description

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

Primary Outcome Measure Information:

Title

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])

Time Frame

18 weeks

Secondary Outcome Measure Information:

Title

Objective response rate

Time Frame

Six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ye Guo, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Cancer Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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