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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

Resolved Hepatitis BCD20 Positive B-cell Lymphoma

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

Inclusion Criteria6

  • 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 Criteria5

  • 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.

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