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.
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 CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
82
entecavir 0.5 mg/day PO
lamivudine 100 mg/day PO
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence rate of HBV reactivation
Defined by increased level of HBV DNA
Time frame: 12 months
Incidence rate of hepatitis and HBV reactivation-related hepatitis
Defined by increased level of alanine transaminase
Time frame: 6 months
Incidence rate and median time of treatment delay due to hepatitis
Measured by information of treatment delay
Time frame: 6 months
Incidence rate and median time of HBV DNA level normalization
Measured by information of HBV DNA level normalization
Time frame: 6 months
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