Status:
UNKNOWN
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL
Lead Sponsor:
Fudan University
Conditions:
Non-Hodgkin Lymphoma
Hepatitis B Reactivation
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.
Detailed Description
In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CH...
Eligibility Criteria
Inclusion
- Previously untreated NHL suitable for CHOP/R-CHOP treatment
- Age range 18-80 years old
- HBsAg positive with high level of HBV DNA
- Eastern Cooperative Oncology Group performance status 0-2
- Life expectancy of more than 3 months
- Adequate organ function
Exclusion
- Primary or secondary central nervous system involvement
- With hepatitis C virus infection
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01914744
Start Date
February 1 2013
End Date
December 1 2016
Last Update
August 2 2013
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032