RecruitingPhase 2NCT05453435

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)

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) (REHEB):a Single Arm, Open Label, Multi-center Phase II Study


Sponsor

Sun Yat-sen University

Enrollment

84 participants

Start Date

Jul 15, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether taking an antiviral drug called entecavir preventively can stop hepatitis B from reactivating in people with B-cell lymphoma who are treated with a type of therapy (anti-CD20 medications like rituximab) known to wake up dormant hepatitis B infections. These patients have past (resolved) hepatitis B but are at risk when their immune system is suppressed. **You may be eligible if...** - You have been diagnosed with CD20-positive B-cell lymphoma - You are about to start first-line lymphoma treatment containing an anti-CD20 antibody (like rituximab) - Your blood tests show past hepatitis B exposure (negative surface antigen, positive core antibody, no detectable virus currently) - Your liver function is adequate **You may NOT be eligible if...** - You currently have active hepatitis B (positive surface antigen or detectable virus) - You have had prior chemotherapy or radiation for lymphoma - You have other liver diseases (hepatitis C, autoimmune hepatitis, cirrhosis) - You are pregnant or breastfeeding - You have HIV or a history of immune deficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEntecavir

All patients enrolled in the study will accept entecavir prophylaxis that initiates within 1 week before the first course of CD20 monoclonal antibody therapy, and continues until 6 months after completing CD20 monoclonal antibody therapy.


Locations(1)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, State..., China

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NCT05453435