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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05453435

Acronym

REHEB

Enrollment

Registered

2022-07-12

Start date

2022-07-15

Completion date

2027-05-01

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CD20 Positive B-cell Lymphoma, Resolved Hepatitis B

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).

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Cumulative HBV reactivation rate	12 months	Cumulative incidence of hepatitis B virus reactivation

Secondary

Measure	Time frame	Description
Incidence of HBV-related liver failure	12 months	Incidence of HBV-related liver failure
Incidence of HBV-related chemotherapy disruption	12 months	Incidence of HBV-related chemotherapy disruption

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026