Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy

Hepatitis B Clinical Trial

Official title:

Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01768195
• Other study ID #: PKU-2012111304
• Status: Recruiting
• Phase: Phase 4
• First received: January 9, 2013
• Last updated: January 8, 2017
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Peking University
• Contact: Jun Zhu
• Email: zj[@]bjcancer.org
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Positive lymphoma patients treated with rituximab-based immunochemotherapy.

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• treatment-naive patients with B-cell lymphoma

• HBsAg positive at baseline

• treated with rituximab-based immunochemotherapy

• life expectancy of more than 3 months

Exclusion Criteria:

• younger than 18 years old

• HBsAg negative at baseline

• pregnant or lactating women

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Lymphoma

Intervention

Drug:
• Entecavir prophylaxis
Entecavir 0.5mg daily from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy. In patients with low load of hepatitis B virus DNA(=2000 IU/ml), rituximab will be administrated at the beginning of entecavir prophylaxis. And in patients with high load of hepatitis B virus DNA(>2000 IU/ml), rituximab will be administrated when hepatitis B virus DNA decreased to the level of 2000 IU/ml after entecavir prophylaxis.

Locations

Country	Name	City	State
China	307 Hospital of the Chinese People's Liberation Army	Beijing	Beijing
China	309 Hospital of the Chinese People's Liberation Army	Beijing	Beijing
China	Aerospace Central Hospital	Beijing	Beijing
China	Air Force General Hospital of the Chinese People's Liberation Army	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Cancer Institute & Hospital, Chinese Academy of Medical Sciences	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	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Cancer Hospital & Institute	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes