Back to resultsEntecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL
Primary Purpose
Non-Hodgkin Lymphoma, Hepatitis B Reactivation
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Entecavir
Lamivudine
Sponsored by
About this trial
This is an interventional prevention trial for Non-Hodgkin Lymphoma focused on measuring NHL, HBV, entecavir, lamivudine
Eligibility 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
Sites / Locations
- Fudan University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
entecavir
lamivudine
Arm Description
entecavir 0.5 mg/day PO
lamivudine 100 mg/day PO
Outcomes
Primary Outcome Measures
Incidence rate of HBV reactivation
Defined by increased level of HBV DNA
Secondary Outcome Measures
Incidence rate of hepatitis and HBV reactivation-related hepatitis
Defined by increased level of alanine transaminase
Incidence rate and median time of treatment delay due to hepatitis
Measured by information of treatment delay
Incidence rate and median time of HBV DNA level normalization
Measured by information of HBV DNA level normalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01914744
Brief Title
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma, Hepatitis B Reactivation
Keywords
NHL, HBV, entecavir, lamivudine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
entecavir
Arm Type
Experimental
Arm Description
entecavir 0.5 mg/day PO
Arm Title
lamivudine
Arm Type
Active Comparator
Arm Description
lamivudine 100 mg/day PO
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
baraclude
Intervention Description
entecavir 0.5 mg/day PO
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Other Intervention Name(s)
epivir
Intervention Description
lamivudine 100 mg/day PO
Primary Outcome Measure Information:
Title
Incidence rate of HBV reactivation
Description
Defined by increased level of HBV DNA
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence rate of hepatitis and HBV reactivation-related hepatitis
Description
Defined by increased level of alanine transaminase
Time Frame
6 months
Title
Incidence rate and median time of treatment delay due to hepatitis
Description
Measured by information of treatment delay
Time Frame
6 months
Title
Incidence rate and median time of HBV DNA level normalization
Description
Measured by information of HBV DNA level normalization
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Incidence of drug resistance of viral variants
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Guo, MD
Phone
+86 21 64175590
Ext
8906
Email
pattrick_guo@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Phone
+86 21 64175590
Ext
8906
Email
pattrick_guo@msn.com
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
12. IPD Sharing Statement
Learn more about this trial
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL
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