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


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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])

Outcome Time Frame:

18 weeks

Safety Issue:

Yes

Principal Investigator

Ye Guo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

LMTG 09-01

NCT ID:

NCT00854568

Start Date:

March 2009

Completion Date:

December 2012

Related Keywords:

  • Lymphoma
  • B-cell lymphoma
  • CHOP
  • CEOP
  • Cardiotoxicity
  • Lymphoma
  • Lymphoma, B-Cell

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