Back to resultsEntecavir 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)
Primary Purpose
Resolved Hepatitis B, CD20 Positive B-cell Lymphoma
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Entecavir
Sponsored by
About this trial
This is an interventional treatment trial for Resolved Hepatitis B
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Entecavir prophylaxis
Arm Description
0.5mg qd
Outcomes
Primary Outcome Measures
12-month HBV reactivation rate
Cumulative incidence of hepatitis B virus reactivation at months 12 after completion of CD20 monoclonal antibody therapy
Secondary Outcome Measures
Incidence of HBV-related liver failure
Incidence of HBV-related liver failure
Incidence of HBV-related chemotherapy disruption
Incidence of HBV-related chemotherapy disruption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05453435
Brief 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)
Acronym
REHEB
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) (REHEB)：a Single Arm, Open Label, Multi-center Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2022 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This phase 2 trial aims to evaluate the efficacy of entecavir prophylacxis for hepatitis B virus (HBV) reactivation that continues until 12 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resolved Hepatitis B, CD20 Positive B-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Entecavir prophylaxis
Arm Type
Experimental
Arm Description
0.5mg qd
Intervention Type
Drug
Intervention Name(s)
Entecavir
Intervention Description
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 12 months after completing CD20 monoclonal antibody therapy.
Primary Outcome Measure Information:
Title
12-month HBV reactivation rate
Description
Cumulative incidence of hepatitis B virus reactivation at months 12 after completion of CD20 monoclonal antibody therapy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of HBV-related liver failure
Description
Incidence of HBV-related liver failure
Time Frame
12 months
Title
Incidence of HBV-related chemotherapy disruption
Description
Incidence of HBV-related chemotherapy disruption
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Cai, PhD
Phone
0086-20-87342823
Email
caiqq@sysucc.org.cn
12. IPD Sharing Statement
Learn more about this trial
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)
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