Comparison Study of Doxorubicin Versus Epirubicin-induced Cardiotoxicity in Patients With DLBCL
NCT00854568 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 398
Last updated 2014-08-20
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.
Conditions
Interventions
- DRUG
-
CEOP regimen
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
- DRUG
-
CHOP regimen
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
Sponsors & Collaborators
-
Fudan University
lead OTHER
Principal Investigators
-
Ye Guo, MD · Fudan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2012-12-31
- Completion
- 2013-02-28
Countries
- China
Study Locations
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