Actively Recruiting
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)
Led by Sun Yat-sen University · Updated on 2024-05-07
84
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed CD20 positive B-cell lymphoma
- Planned first-line anti-lymphoma therapy containing CD20 monoclonal antibodies
- Negative hepatitis B surface antigen (HBsAg)
- Hepatitis B virus DNA lower than detection limit at baseline
- Positive hepatitis B core antibody (anti-HBC) at baseline
- Total bilirubin less than 1.5 times upper limit of normal
- AST and ALT less than 2.5 times upper limit of normal
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2
- Estimated survival time longer than 3 months
You will not qualify if you...
- Positive hepatitis B surface antigen (HBsAg) or HBV-DNA higher than 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, other acquired or congenital immunodeficiency, or history of organ transplantation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, State..., China, 510060
Actively Recruiting
Research Team
Q
Qingqing Cai, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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