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)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Resolved Hepatitis B, CD20 Positive B-cell Lymphoma

Intervention / Treatment
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* Drug: Entecavir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Entecavir prophylaxis<br>0.5mg qd | Drug: Entecavir<br>* 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 12 months after completing CD20 monoclonal antibody therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month HBV reactivation rate | Cumulative incidence of hepatitis B virus reactivation at months 12 after completion of CD20 monoclonal antibody therapy | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of HBV-related liver failure | Incidence of HBV-related liver failure | 12 months | 
| Incidence of HBV-related chemotherapy disruption | Incidence of HBV-related chemotherapy disruption | 12 months |