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

January 8, 2017 updated by: Jun Zhu, Peking University
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Positive lymphoma patients treated with rituximab-based immunochemotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital & Institute
      • Beijing, Beijing, China
        • Recruiting
        • Peking University People's Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Peking University Third Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Cancer Institute & Hospital, Chinese Academy of Medical Sciences
      • Beijing, Beijing, China
        • Recruiting
        • Peking University First Hospital
      • Beijing, Beijing, China
        • Recruiting
        • 307 Hospital of the Chinese People's Liberation Army
      • Beijing, Beijing, China
        • Recruiting
        • 309 Hospital of the Chinese People's Liberation Army
      • Beijing, Beijing, China
        • Recruiting
        • Aerospace Central Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Air Force General Hospital of the Chinese People's Liberation Army
      • Beijing, Beijing, China
        • Recruiting
        • First Hospital affiliated to General Hospital of the Chinese People's Liberation Army
      • Beijing, Beijing, China
        • Recruiting
        • General Hospital of Chinese People's Liberation Army

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Baraclude

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
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
Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
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
Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
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
Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

January 9, 2013

First Submitted That Met QC Criteria

January 12, 2013

First Posted (ESTIMATE)

January 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 8, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKU-2012111304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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