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NCT Number: NCT00854568

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

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.

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Key information

Conditions

Lymphoma Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CEOP regimen

Drug

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

Other names: CEOP

CHOP regimen

Drug

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

Other names: CHOP

Primary outcomes

  1. 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 outcomes

  1. Objective response rate

    Time frame: Six weeks

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Mar 3, 2009
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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