Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody)

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase 2 trial aims to evaluate the efficacy of entecavir prophylacxis for hepatitis B virus (HBV) reactivation that continues until 12 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Entecavir

Criteria

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.