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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is common in cancer patients who have chronic HBV infection. It is best characterized in patients with hematological malignancies such as non-Hodgkin's lymphoma but also can occur in patients with solid tumors. Reactivation during the initiation of chemotherapy may cause delay in cancer treatment and decrease in overall survival. The direct mortality caused by HBV reactivation, predominantly acute liver failure, ranges from 4% to 60%. Based on currently available information, it is well documented that HBV carriers should receive antiviral agents to prevent hepatitis B flare before receiving immunosuppressive agents and chemotherapy. However, development of hepatitis, acute liver failure, and mortality can occur among patients who are HBsAg negative but anti-HBc positive at the time of chemotherapy. Therefore, before the initiation of cytotoxic chemotherapy in cases of non-Hodgkin's lymphoma, it is unknown whether patients previous infected by HBV but negative HBsAg should routinely receive antiviral agents for prevention of HBV flare. In addition, the major concern of long-term lamivudine use is the selection of drug-resistant mutations. Based on these, we designed this current study to address the above important issues. Eligible patients are newly diagnosed, histologically proven anti-CD20-positive non-Hodgkin's lymphoma at our hospital. Patients should be negative of HBsAg but positive of serum anti-HBc. After signing the patient consent form, serum samples will be stored for further genotyping and quantitative HBV DNA testing. Patients will be randomized into two groups. In the prophylactic use group, participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of chemotherapy. Entecavir treatment will be continued until 3 months after the completion of chemotherapy and achieving the remission of the hepatitis (ALT normalization and undetectable HBV DNA). In the therapeutic use group, patients will start entecavir therapy, 0.5 mg/day orally, only when elevation of ALT (\>100 U/L) and HBV DNA (\>2000 IU/ml) developed during follow-up, or in the situation of HBsAg reverse seroconversion, and continued entecavir treatment until hepatitis resolved. The primary endpoint is the incidence of HBV reactivation during and within 12 months after completing chemotherapy in diffuse large B cell or follicular lymphoma patients who receive R-CHOP regimen. The secondary endpoint is the incidence of HBsAg reverse seroconversion during and within 12 months after completing chemotherapy.

Conditions

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Non Hodgkin's Lymphoma Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Entecavir prophylaxis

Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of chemotherapy, and will be continued until 3 months after completion of the chemotherapy.

Group Type EXPERIMENTAL

Entecavir prophylaxis

Intervention Type DRUG

Entecavir 0.5mg daily from day 1 of chemotherapy to 3 months after completing chemotherapy

Therapeutic arm

In patients with HBV reactivation and ALT flare \> 100 U/L, entecavir 0.5mg daily will be prescribed for the cases till hepatitis remission

Group Type ACTIVE_COMPARATOR

Therapeutic entecavir

Intervention Type DRUG

Entecavir 0.5cm daily since hepatitis flare and HBV reactivation, till hepatitis remission

Interventions

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Entecavir prophylaxis

Entecavir 0.5mg daily from day 1 of chemotherapy to 3 months after completing chemotherapy

Intervention Type DRUG

Therapeutic entecavir

Entecavir 0.5cm daily since hepatitis flare and HBV reactivation, till hepatitis remission

Intervention Type DRUG

Other Intervention Names

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Baraclude Baraclude

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No