Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP
This trial is active, not recruiting.
|Treatment||nucleoside analog reverse transcriptase inhibitor|
|Phase||phase 2/phase 3|
|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|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment.
incidence of HBV reactivation
time frame: from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP
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
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
|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|
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