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

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01914744

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin Lymphoma Hepatitis B Reactivation	Drug: Entecavir Drug: Lamivudine	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: entecavir entecavir 0.5 mg/day PO	Drug: Entecavir entecavir 0.5 mg/day PO Other Names: baraclude Drug: Lamivudine lamivudine 100 mg/day PO Other Names: epivir
Active Comparator: lamivudine lamivudine 100 mg/day PO	Drug: Entecavir entecavir 0.5 mg/day PO Other Names: baraclude Drug: Lamivudine lamivudine 100 mg/day PO Other Names: epivir

Arm

Intervention/Treatment

Experimental: entecavir

entecavir 0.5 mg/day PO

Drug: Entecavir

entecavir 0.5 mg/day PO

Other Names:

baraclude

Drug: Lamivudine

lamivudine 100 mg/day PO

Other Names:

epivir

Active Comparator: lamivudine

lamivudine 100 mg/day PO

Drug: Entecavir

entecavir 0.5 mg/day PO

Other Names:

baraclude

Drug: Lamivudine

lamivudine 100 mg/day PO

Other Names:

epivir

Outcome Measures

Primary Outcome Measures

Incidence rate of HBV reactivation [12 months]
Defined by increased level of HBV DNA

Secondary Outcome Measures

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

Other Outcome Measures

Incidence of drug resistance of viral variants [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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