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

Phase 2

• Conditions: Lymphoma
• Interventions: Drug: nucleoside analog reverse transcriptase inhibitor

• Registration Number: NCT01210287
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Study Start: 2010-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-01-08
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observation	nucleoside analog reverse transcriptase inhibitor	Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment.

Primary Outcome Measures

Name	Time	Method
incidence of HBV reactivation	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).

Secondary Outcome Measures

Name	Time	Method
the outcome of antiviral therapy in HBV-DNA abnormal patients	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.

Trial Locations

Locations (2)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China