Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy
- Registration Number
- NCT01768195
- Lead Sponsor
- Peking University
- Brief Summary
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Positive lymphoma patients treated with rituximab-based immunochemotherapy.
- Detailed Description
HBsAg Positive lymphoma patients are treated with entecavir when they receive rituximab-based immunochemotherapy. Entecavir 0.5mg daily is administrated from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- treatment-naive patients with B-cell lymphoma
- HBsAg positive at baseline
- treated with rituximab-based immunochemotherapy
- life expectancy of more than 3 months
- younger than 18 years old
- HBsAg negative at baseline
- pregnant or lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Entecavir prophylaxis Entecavir prophylaxis Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of immunochemotherapy and/or chemotherapy, and will be continued until 12 months after completion of the immunochemotherapy and/or chemotherapy.
- Primary Outcome Measures
Name Time Method the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
- Secondary Outcome Measures
Name Time Method the incidence of hepatitis B virus virological response from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy the incidence of hepatitis B virus serological response from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy the incidence of hepatitis B virus maintained response from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy the incidence of hepatitis B virus sustained response from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy the incidence of hepatitis B virus relapse and relapse related hepatitis from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
Trial Locations
- Locations (13)
309 Hospital of the Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
Air Force General Hospital of the Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Peking University Cancer Hospital & Institute
🇨🇳Beijing, Beijing, China
Aerospace Central Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
First Hospital affiliated to General Hospital of the Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
General Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
307 Hospital of the Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China