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

Fudan University110 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

110

Conditions

Lymphoma

Interventions

nucleoside analog reverse transcriptase inhibitorDRUG

tablets 100mg qd

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

incidence of HBV reactivation

HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).

Time frame: from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP

Secondary Outcomes

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.

Time frame: from the initiation of antiviral thearpy to six months after the last cycle of RCHOP

Data from ClinicalTrials.gov

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