Trial Information
Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
incidence of HBV reactivation
Outcome Description:
HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).
Outcome Time Frame:
from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP
Safety Issue:
Yes
Principal Investigator
Junning Cao, Doctor
Investigator Role:
Principal Investigator
Investigator Affiliation:
member of Fudan University
Authority:
China: Ethics Committee
Study ID:
201010HBV
NCT ID:
NCT01210287
Start Date:
October 2010
Completion Date:
December 2013
Related Keywords:
- Lymphoma
- hepatitis B virus reactivation
- HBsAg negative
- HBcAb positive
- lymphoma
- rituximab
- Hepatitis
- Hepatitis B
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse