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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01914744

Enrollment

Registered

2013-08-02

Start date

2013-02-28

Completion date

2016-12-31

Last updated

2013-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Reactivation, Non-Hodgkin Lymphoma

Keywords

NHL, HBV, entecavir, lamivudine

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.

Interventions

DRUGEntecavir

entecavir 0.5 mg/day PO

DRUGLamivudine

lamivudine 100 mg/day PO

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence rate of HBV reactivation	12 months	Defined by increased level of HBV DNA

Secondary

Measure	Time frame	Description
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

Measure	Time frame
Incidence of drug resistance of viral variants	3 years

Countries

China

Contacts

Primary ContactYe Guo, MD

pattrick_guo@msn.com+86 21 64175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026