Comparison Study of Doxorubicin Versus Epirubicin-induced Cardiotoxicity in Patients With DLBCL
A Randomized Phase III Study Comparing CHOP Versus CEOP-induced Cardiotoxicity in Patients With Aggressive B-cell Lymphoma
1 other identifier
interventional
398
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 lymphoma
Started Mar 2009
Shorter than P25 for phase_3 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 2, 2009
CompletedFirst Posted
Study publicly available on registry
March 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedAugust 20, 2014
August 1, 2014
3.8 years
March 2, 2009
August 19, 2014
Conditions
Keywords
Outcome Measures
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])
18 weeks
Secondary Outcomes (1)
Objective response rate
Six weeks
Study Arms (2)
CEOP regimen
EXPERIMENTALCEOP regimen
CHOP regimen
ACTIVE COMPARATORCHOP regimen
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ye Guo, MD
Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
March 2, 2009
First Posted
March 3, 2009
Study Start
March 1, 2009
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
August 20, 2014
Record last verified: 2014-08