Lymphoma
Conditions
Keywords
hepatitis B virus reactivation, HBsAg negative, HBcAb positive, lymphoma, rituximab
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.
Interventions
DRUGnucleoside analog reverse transcriptase inhibitor
tablets 100mg qd
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed