Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL

Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study

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.

Inclusion Criteria:

• 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 Criteria:

• 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