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NCT Number: NCT05453435

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)

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Guangzhou, State..., 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Cumulative HBV reactivation rate

    Time frame: 12 months

    Cumulative incidence of hepatitis B virus reactivation

Secondary outcomes

  1. Incidence of HBV-related liver failure

    Time frame: 12 months

    Incidence of HBV-related liver failure

  2. Incidence of HBV-related chemotherapy disruption

    Time frame: 12 months

    Incidence of HBV-related chemotherapy disruption

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: REHEB

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 12, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.