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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-Hodgkin Lymphoma, Hepatitis B Reactivation

Intervention / Treatment
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* Drug: Entecavir
* Drug: Lamivudine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: entecavir<br>entecavir 0.5 mg/day PO | Drug: Entecavir<br>* entecavir 0.5 mg/day PO<br>* Other names: baraclude;Drug: Lamivudine<br>* lamivudine 100 mg/day PO<br>* Other names: epivir;|
| Active Comparator: lamivudine<br>lamivudine 100 mg/day PO | Drug: Entecavir<br>* entecavir 0.5 mg/day PO<br>* Other names: baraclude;Drug: Lamivudine<br>* lamivudine 100 mg/day PO<br>* Other names: epivir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of HBV reactivation | Defined by increased level of HBV DNA | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of hepatitis and HBV reactivation-related hepatitis | Defined by increased level of alanine transaminase | 6 months | 
| Incidence rate and median time of treatment delay due to hepatitis | Measured by information of treatment delay | 6 months | 
| Incidence rate and median time of HBV DNA level normalization | Measured by information of HBV DNA level normalization | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV, entecavir, lamivudine, NHL