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

Lymphoma Clinical Trial

— IHBVRL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01210287
• Other study ID #: 201010HBV
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 27, 2010
• Last updated: January 7, 2014
• Start date: October 2010
• Est. completion date: August 2014

Study information

• Verified date: January 2014
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• nucleoside analog reverse transcriptase inhibitor
tablets 100mg qd

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of HBV reactivation	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	Yes
Secondary	the outcome of antiviral therapy in HBV-DNA abnormal patients	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	Yes