Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP (IHBVRL)
|ClinicalTrials.gov Identifier: NCT01210287|
Recruitment Status : Unknown
Verified January 2014 by Junning Cao, Fudan University.
Recruitment status was: Active, not recruiting
First Posted : September 28, 2010
Last Update Posted : January 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: nucleoside analog reverse transcriptase inhibitor||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2014|
No Intervention: Observation
Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment.
Drug: nucleoside analog reverse transcriptase inhibitor
tablets 100mg qd
Other Name: lamivudine
- incidence of HBV reactivation [ Time Frame: 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).
- 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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210287
|Fudan University Shanghai Cancer Center|
|Shanghai, Shanghai, China, 200032|
|Fudan University Cancer Hospital|
|Shanghai, Shanghai, China, 86-21|
|Principal Investigator:||Junning Cao, Doctor||member of Fudan University|