Overview
This phase 2 trial aims to evaluate the efficacy of entecavir prophylacxis for hepatitis B virus (HBV) reactivation that continues until 6 months after completing CD20 monoclonal antibody therapy in patients with CD20-positive B-cell lymphomas and resolved hepatitis B (negative hepatitis B surface antigen, positive hepatitis B core antibody).
Eligibility
Inclusion Criteria:
- Histopathologically confirmed CD20 positive B-cell lymphoma;
- Plan to receive first-line anti-lymphoma therapy containing CD20 monoclonal antibodies;
- Negative HBsAg, HBV-DNA lower than the detection limit and positive anti-HBC at baseline;
- Total bilirubin less than 1.5X the upper limit of normal (ULN), AST and ALT less than 2.5X ULN;
- ECOG PS: 0~2;
- Estimated survival time >3 months.
Exclusion Criteria:
- Positive HBsAg or HBV-DNA higher than the detection limit at baseline;
- Previous chemotherapy or radiotherapy for lymphoma;
- Other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, Wilson' s disease or primary biliary cirrhosis;
- Pregnant or lactating women;
- History of immunodeficiency, including positive HIV, or other acquired congenital immunodeficiency disease, or history of organ transplantation.