Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP (IHBVRL)

January 7, 2014 updated by: Junning Cao, Fudan University

Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study

The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis B undergoing RCHOP immuno-chemotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2
  • Phase 3

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
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai, China, 86-21
        • Fudan University Cancer Hospital

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Naive DLBCL or high grade FL patients
  • Age range 18-75 years old
  • ECOG performance status 0-3
  • Life expectancy of more than 3 months
  • Adequate organ function
  • HBsAg negative/HBcAb positive at baseline

Exclusion Criteria:

  • Infection of HAV,HCV,HIV
  • Pregnant or lactating women
  • Serious uncontrolled diseases

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observation
Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment.
Drug: nucleoside analog reverse transcriptase inhibitor
tablets 100mg qd
Other Names:
  • lamivudine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of HBV reactivation
Time Frame: from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP
HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).
from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the outcome of antiviral therapy in HBV-DNA abnormal patients
Time Frame: from the initiation of antiviral thearpy to six months after the last cycle of RCHOP
Once the level of HBV-DNA exceeds the upper limit of normal, antiviral therapy will be given immediately.Liver function and serum HBsAg and HBcAg of these patients will be monitored until six months after the last dosing of RCHOP.
from the initiation of antiviral thearpy to six months after the last cycle of RCHOP

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Junning Cao, Doctor, member of Fudan 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

October 1, 2010

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimate)

September 28, 2010

Study Record Updates

Last Update Posted (Estimate)

January 8, 2014

Last Update Submitted That Met QC Criteria

January 7, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201010HBV

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.

Clinical Trials on Lymphoma

Clinical Trials on nucleoside analog reverse transcriptase inhibitor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe