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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Junning Cao, Fudan University
ClinicalTrials.gov Identifier:
NCT01210287
First received: September 27, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Lymphoma
Drug: nucleoside analog reverse transcriptase inhibitor
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • incidence of HBV reactivation [ Time Frame: from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP ] [ Designated as safety issue: Yes ]
    HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 110
Study Start Date: October 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210287

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

No publications provided

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
Study First Received: September 27, 2010
Last Updated: January 7, 2014
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
hepatitis B virus reactivation
HBsAg negative
HBcAb positive
lymphoma
rituximab

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 15, 2014