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)

Phase 2

Recruiting

• Conditions: CD20 Positive B-cell Lymphoma; Resolved Hepatitis B
• Interventions: Drug: Entecavir

• Registration Number: NCT05453435
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-02
• Study First Submitted QC: 2022-07-10
• Study First Posted: 2022-07-12
• Study Start: 2022-07-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-04
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Entecavir prophylaxis	Entecavir	0.5mg qd

Primary Outcome Measures

Name	Time	Method
Cumulative HBV reactivation rate	12 months	Cumulative incidence of hepatitis B virus reactivation

Secondary Outcome Measures

Name	Time	Method
Incidence of HBV-related liver failure	12 months	Incidence of HBV-related liver failure
Incidence of HBV-related chemotherapy disruption	12 months	Incidence of HBV-related chemotherapy disruption

Trial Locations

Locations (1)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University; 🇨🇳 Guangzhou, State..., China