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

Fudan University logo

Fudan University

Status and phase

Completed
Phase 3

Conditions

Lymphoma

Treatments

Drug: CEOP regimen
Drug: CHOP regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT00854568
LMTG 09-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

398 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

398 participants in 2 patient groups

CEOP regimen
Experimental group
Description:
CEOP regimen
Treatment:
Drug: CEOP regimen
CHOP regimen
Active Comparator group
Description:
CHOP regimen
Treatment:
Drug: CHOP regimen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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