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

Phase 2

• Conditions: Non-Hodgkin Lymphoma; Hepatitis B Reactivation
• Interventions: Drug: Entecavir; Drug: Lamivudine

• Registration Number: NCT01914744
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-02
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-31
• Last Update Submitted: 2013-07-31
• Study First Posted: 2013-08-02
• Last Update Posted: 2013-08-02
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
entecavir	Lamivudine	entecavir 0.5 mg/day PO
lamivudine	Entecavir	lamivudine 100 mg/day PO
entecavir	Entecavir	entecavir 0.5 mg/day PO
lamivudine	Lamivudine	lamivudine 100 mg/day PO

Primary Outcome Measures

Name	Time	Method
Incidence rate of HBV reactivation	12 months	Defined by increased level of HBV DNA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China