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: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Cumulative HBV reactivation rate — 12 months Cumulative incidence of hepatitis B virus reactivation
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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