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

Non-Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01914744
• Other study ID #: LMTG 13-03
• Status: Recruiting
• Phase: Phase 2
• First received: March 2, 2013
• Last updated: July 31, 2013
• Start date: February 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2013
• Source: Fudan University
• Contact: Ye Guo, MD
• Phone: +86 21 64175590
• Email: pattrick_guo[@]msn.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Reactivation
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• Entecavir
entecavir 0.5 mg/day PO
• Lamivudine
lamivudine 100 mg/day PO

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of drug resistance of viral variants		3 years	No
Primary	Incidence rate of HBV reactivation	Defined by increased level of HBV DNA	12 months	No
Secondary	Incidence rate of hepatitis and HBV reactivation-related hepatitis	Defined by increased level of alanine transaminase	6 months	No
Secondary	Incidence rate and median time of treatment delay due to hepatitis	Measured by information of treatment delay	6 months	No
Secondary	Incidence rate and median time of HBV DNA level normalization	Measured by information of HBV DNA level normalization	6 months	No