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Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP (IHBVRL)

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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
Information provided by (Responsible Party):
Junning Cao, Fudan University

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.

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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210287

China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 86-21
Sponsors and Collaborators
Fudan University
Principal Investigator: Junning Cao, Doctor member of Fudan University

Responsible Party: Junning Cao, Vice Director of the department of Medical Oncology, Fudan University Cancer Center, Fudan University
ClinicalTrials.gov Identifier: NCT01210287     History of Changes
Other Study ID Numbers: 201010HBV
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014

Keywords provided by Junning Cao, Fudan University:
hepatitis B virus reactivation
HBsAg negative
HBcAb positive

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents