Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT01914744
First received: March 2, 2013
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.


Condition Intervention Phase
Non-Hodgkin Lymphoma
Hepatitis B Reactivation
Drug: Entecavir
Drug: Lamivudine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Incidence rate of HBV reactivation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Defined by increased level of HBV DNA


Secondary Outcome Measures:
  • Incidence rate of hepatitis and HBV reactivation-related hepatitis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Defined by increased level of alanine transaminase

  • Incidence rate and median time of treatment delay due to hepatitis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by information of treatment delay

  • Incidence rate and median time of HBV DNA level normalization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by information of HBV DNA level normalization


Other Outcome Measures:
  • Incidence of drug resistance of viral variants [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: entecavir
entecavir 0.5 mg/day PO
Drug: Entecavir
entecavir 0.5 mg/day PO
Other Name: baraclude
Drug: Lamivudine
lamivudine 100 mg/day PO
Other Name: epivir
Active Comparator: lamivudine
lamivudine 100 mg/day PO
Drug: Entecavir
entecavir 0.5 mg/day PO
Other Name: baraclude
Drug: Lamivudine
lamivudine 100 mg/day PO
Other Name: epivir

Detailed Description:

In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously untreated NHL suitable for CHOP/R-CHOP treatment
  • Age range 18-80 years old
  • HBsAg positive with high level of HBV DNA
  • Eastern Cooperative Oncology Group performance status 0-2
  • Life expectancy of more than 3 months
  • Adequate organ function

Exclusion Criteria:

  • Primary or secondary central nervous system involvement
  • With hepatitis C virus infection
  • Previous serious cardiac disease
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Pregnant or lactating women
  • Serious uncontrolled diseases and intercurrent infection
  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: NCT01914744

Contacts
Contact: Ye Guo, MD +86 21 64175590 ext 8906 pattrick_guo@msn.com

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ye Guo, MD    +86 21 64175590 ext 8906    pattrick_guo@msn.com   
Principal Investigator: Ye Guo, MD         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Ye Guo, MD Fudan University
  More Information

No publications provided

Responsible Party: Ye Guo, Dr., Fudan University
ClinicalTrials.gov Identifier: NCT01914744     History of Changes
Other Study ID Numbers: LMTG 13-03
Study First Received: March 2, 2013
Last Updated: July 31, 2013
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
NHL
HBV
entecavir
lamivudine

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

ClinicalTrials.gov processed this record on September 16, 2014