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)

Sun Yat-sen University

Status and phase

Enrolling

Phase 2

Conditions

Resolved Hepatitis B

CD20 Positive B-cell Lymphoma

Treatments

Drug: Entecavir

Study type

Interventional

Funder types

Other

Identifiers

NCT05453435

B2022-352-01

Details and patient eligibility

About

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).

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.