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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Peking University
Sponsor:
Information provided by (Responsible Party):
Jun Zhu, Peking University
ClinicalTrials.gov Identifier:
NCT01768195
First received: January 9, 2013
Last updated: January 21, 2015
Last verified: January 2015

January 9, 2013
January 21, 2015
January 2013
December 2015   (final data collection date for primary outcome measure)
the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01768195 on ClinicalTrials.gov Archive Site
  • the incidence of hepatitis B virus virological response [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
  • the incidence of hepatitis B virus serological response [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
  • the incidence of hepatitis B virus maintained response [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
  • the incidence of hepatitis B virus sustained response [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
  • the incidence of hepatitis B virus relapse and relapse related hepatitis [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy
Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Positive lymphoma patients treated with rituximab-based immunochemotherapy.
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.
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B
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.

Other Name: Baraclude
Experimental: 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.
Intervention: Drug: Entecavir prophylaxis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact: Jun Zhu zj@bjcancer.org
Contact: Yuqin Song songyuqin622@sina.com
China
 
NCT01768195
PKU-2012111304
Yes
Not Provided
Not Provided
Jun Zhu, Peking University
Peking University
Not Provided
Principal Investigator: Jun Zhu Peking University Cancer Hospital & Institute
Peking University
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP