Prophylactic Use of Entecavir for Non-Hodgkin's Lymphoma Patients With Resolved Hepatitis B

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is common in cancer patients who have chronic HBV infection. Lymphoma patients who had previous infected by HBV but negative for HBsAg have a the risk of HBV reactivation during chemotherapy, but prophylactic antiviral treatment is not a routine by current American Association for the Study of Liver Diseases (AASLD) guideline. Prophylactic entecavir might reduce the risk of HBV reactivation in such patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborator: Bristol-Myers Squibb
• Treatments: Entecavir

Criteria

Inclusion Criteria:

• CD20 positive lymphoma

• negative for HBsAg and positive for anti-HBc

• age over 16 years old

• alanine aminotransferase less than 2 times the upper limit of normal

• bilirubin < 2.5 mg/dL

• neutrophil > 2000/mm3

• platelet > 100,000/mm3

• creatinine < 1.5 mg/dL

• urea nitrogen < 25 mg/dL

• Eastern Cooperative Oncology Group performance score 0 to 2

Exclusion Criteria:

• Child-Pugh class B or C cirrhosis

• grade 2 or greater heart failure by the NYHA classification

• previous chemotherapy,radiotherapy, or concurrent glucocorticoid therapy for other reasons

• other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, or Wilsons' disease