Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy

Peking University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B

Treatments: Drug: Entecavir prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT01768195

PKU-2012111304

Details and patient eligibility

About

The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Positive lymphoma patients treated with rituximab-based immunochemotherapy.

Full description

HBsAg Positive lymphoma patients are treated with entecavir when they receive rituximab-based immunochemotherapy. Entecavir 0.5mg daily is administrated from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• treatment-naive patients with B-cell lymphoma
• HBsAg positive at baseline
• treated with rituximab-based immunochemotherapy
• life expectancy of more than 3 months

Exclusion criteria

• younger than 18 years old
• HBsAg negative at baseline
• pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Entecavir prophylaxis

Experimental group

Description:

Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of immunochemotherapy and/or chemotherapy, and will be continued until 12 months after completion of the immunochemotherapy and/or chemotherapy.

Treatment:

Drug: Entecavir prophylaxis