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)

NCT05453435 | Recruiting Phase 2

• 1 other identifier: B2022-352-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Resolved Hepatitis B; CD20 Positive B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Cumulative HBV reactivation rate

  Cumulative incidence of hepatitis B virus reactivation

  12 months

Secondary Outcomes (2)

• Incidence of HBV-related liver failure

  12 months

• Incidence of HBV-related chemotherapy disruption

  12 months

Study Arms (1)

Entecavir prophylaxis

EXPERIMENTAL

0.5mg qd

Drug: Entecavir

Interventions

Entecavir DRUG

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.

Entecavir prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, State..., 510060, China

RECRUITING

MeSH Terms

Interventions

entecavir

Central Study Contacts

Qingqing Cai, PhD

CONTACT

0086-20-87342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 12, 2022
• Study Start: July 15, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

CN (1)