Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients

Sponsor

Peking University (Other)

Overall Status

Completed

CT.gov ID

NCT02108444

Collaborator

(none)

107

Enrollment

Location

85.9

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a retrospective analysis to explore the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus infection.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis Hepatitis B Lymphoma Hematologic Diseases

Detailed Description

All eligible patients received prophylactic antiviral therapy during and within 6 months after chemotherapy in previous sudy. We did not assign specific interventions to the subjects in this study. The primary endpoint of this study is the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy. The secondary endpoints include the incidence of hepatitis flare related to hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the tumor response rate, and overall survival rate.

Study Design

Study Type:

Observational

Actual Enrollment :

107 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients With Hepatitis B Virus Infection

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
group with HBV reactivation group with hepatitis B virus reactivation
group without HBV reactivation group without hepatitis B virus reactivation

Outcome Measures

Primary Outcome Measures

the incidence of hepatitis B virus delayed reactivation [within one year after withdrawal of prophylactic antiviral therapy]
hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy

Secondary Outcome Measures

the incidence of hepatitis B virus related hepatitis flare [within one year after withdrawal of prophylactic antiviral therapy]
the incidence of hepatitis B virus related hepatitis flare after withdrawal of prophylactic antiviral therapy
Number of patients that achieve a tumor response [within one year after withdrawal of prophylactic antiviral therapy]
overall survival rate [within one year after withdrawal of prophylactic antiviral therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

treatment-naive patients with lymphoma
patients with a history of previous exposure to hepatitis B virus (HBV): HBsAg or hepatitis B core antibody (anti-HBc) positive