Preventing Hepatitis B Reactivation in Lymphoma Patients
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
This study is testing if a medication called entecavir can help prevent hepatitis B from coming back in lymphoma patients who have had the virus in the past and are starting treatment for their cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, State...) |
| Trial ID | NCT05453435 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial evaluates the effectiveness of entecavir as a preventive treatment for hepatitis B virus reactivation in patients with CD20-positive B-cell lymphoma who have resolved hepatitis B. The study focuses on patients who are set to receive first-line anti-lymphoma therapy that includes CD20 monoclonal antibodies. Participants must have a negative hepatitis B surface antigen and positive hepatitis B core antibody, ensuring they are at risk for reactivation. The treatment will continue for six months after completing their lymphoma therapy.
Who should consider this trial
Good fit: Ideal candidates are patients with histopathologically confirmed CD20-positive B-cell lymphoma who have resolved hepatitis B.
Not a fit: Patients with active hepatitis B infection or those with other primary liver diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of hepatitis B reactivation in lymphoma patients, improving their overall treatment outcomes.
How similar studies have performed: Previous studies have shown that prophylactic antiviral therapy can effectively prevent hepatitis B reactivation in similar patient populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, State...
- Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Guangzhou, State..., China (Recruiting)
Study contacts
- Study coordinator: Qingqing Cai, PhD
- Email: caiqq@sysucc.org.cn
- Phone: 0086-20-87342823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.