This trial is active, not recruiting.

Condition lymphoma
Treatment nucleoside analog reverse transcriptase inhibitor
Phase phase 2/phase 3
Sponsor Fudan University
Start date October 2010
End date August 2014
Trial size 110 participants
Trial identifier NCT01210287, 201010HBV


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
(No Intervention)
Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment.
nucleoside analog reverse transcriptase inhibitor lamivudine
tablets 100mg qd

Primary Outcomes

incidence of HBV reactivation
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
time frame: from the initiation of antiviral thearpy to six months after the last cycle of RCHOP

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Principal investigator Junning Cao, Doctor
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Fudan University.