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 2013 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 12, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Hepatitis B
Drug: Entecavir prophylaxis
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768195

Contacts
Contact: Jun Zhu zj@bjcancer.org
Contact: Yuqin Song songyuqin622@sina.com

Locations
China, Beijing
Peking University Cancer Hospital & Institute Recruiting
Beijing, Beijing, China, 100142
Contact: Jun Zhu       zj@bjcancer.org   
Contact: Yuqin Song       songyuqin622@sina.com   
Principal Investigator: Jun Zhu         
Peking University First Hospital Recruiting
Beijing, Beijing, China
Contact: Hanyun Ren         
Principal Investigator: Hanyun Ren         
Peking University People's Hospital Recruiting
Beijing, Beijing, China
Contact: Xiaojun Huang         
Principal Investigator: Xiaojun Huang         
Peking University Third Hospital Recruiting
Beijing, Beijing, China
Contact: Xiaoyan Ke         
Principal Investigator: Xiaoyan Ke         
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: Daobin Zhou         
Principal Investigator: Daobin Zhou         
Beijing Hospital Recruiting
Beijing, Beijing, China
Contact: Hui Liu         
Principal Investigator: Hui Liu         
General Hospital of Chinese People's Liberation Army Recruiting
Beijing, Beijing, China
Contact: Li Yu         
Principal Investigator: Li Yu         
First Hospital affiliated to General Hospital of the Chinese People's Liberation Army Recruiting
Beijing, Beijing, China
Contact: Xiaoxiong Wu         
Principal Investigator: Xiaoxiong Wu         
307 Hospital of the Chinese People's Liberation Army Recruiting
Beijing, Beijing, China
Contact: Weijing Zhang         
Principal Investigator: Weijing Zhang         
309 Hospital of the Chinese People's Liberation Army Recruiting
Beijing, Beijing, China
Contact: Liping Ye         
Principal Investigator: Liping Ye         
Aerospace Central Hospital Recruiting
Beijing, Beijing, China
Contact: Jingbo Wang         
Principal Investigator: Jingbo Wang         
Air Force General Hospital of the Chinese People's Liberation Army Recruiting
Beijing, Beijing, China
Contact: Mei Xue         
Principal Investigator: Mei Xue         
Cancer Institute & Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China
Contact: Yuankai Shi         
Principal Investigator: Yuankai Shi         
Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Jun Zhu Peking University Cancer Hospital & Institute
  More Information

No publications provided

Responsible Party: Jun Zhu, Peking University Cancer Hospital & Institute, Peking University
ClinicalTrials.gov Identifier: NCT01768195     History of Changes
Other Study ID Numbers: PKU-2012111304
Study First Received: January 9, 2013
Last Updated: January 12, 2013
Health Authority: China: Ethics Committee

Keywords provided by Peking University:
Lymphoma
Hepatitis B Virus
Therapeutic Uses
Antiviral Agents
rituximab

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Rituximab
Entecavir
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 20, 2014