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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
RECRUITING
Guangzhou
Contact Information
Primary
Qingqing Cai, PhD
caiqq@sysucc.org.cn
0086-20-87342823
Time Frame
Start Date: 2022-07-15
Estimated Completion Date: 2025-07
Participants
Target number of participants: 84
Treatments
Experimental: Entecavir prophylaxis
0.5mg qd
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University