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

This study is currently recruiting participants.
Verified February 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Junning Cao, Fudan University
ClinicalTrials.gov Identifier:
NCT01210287
First received: September 27, 2010
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  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:

Drug Information available for: Lamivudine
U.S. FDA Resources

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: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Observation
Observation of the HBV reactivation in HBsAg negative/HBsAg 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210287

Contacts
Contact: Dongmei Ji, Doctor 86-21-64175590 ext 8908 jidongmei2000@hotmail.com

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 86-21
Contact: Dongmei Ji, MD     86-21-64175590 ext 3653     jidongmei2000@hotmail.com    
Principal Investigator: Junning Cao, MD            
Sub-Investigator: Dongmei Ji, MD            
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Yanfei Liu, master     862164175590 ext 8218     yanfliu2004@hotmail.com    
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: February 28, 2013
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, Large B-Cell, Diffuse
Hepatitis, Viral, Human
Lymphoma, B-Cell
Lymphoma
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
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 May 23, 2013