Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Hepatitis A

Hepatitis

Hepatitis B

Virus Diseases

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Communicable Diseases

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Blood-Borne Infections

Hepadnaviridae Infections

DNA Virus Infections

Lymphosarcoma

Herpes Simiae (B Virus)

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Rituximab

Entecavir

Antiviral Agents

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.

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

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

Entecavir prophylaxis

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

Therapeutic entecavir

Yi-Hsiang Huang, MD, PhD

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.

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.

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

Prophylactic Use of Entecavir for Chemotherapy Associated With Hepatitis B Reactivation in HBsAg (-), Anti-HBc (+) Non-Hodgkin's Lymphoma Patients: a Randomized Controlled Trial

Bristol-Myers Squibb

Taipei Veterans General Hospital, Taiwan

Yi-Hsiang Huang, Professor

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.

Entecavir 0.5mg daily from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy.

In patients with low load of hepatitis B virus DNA(≤2000 IU/ml), rituximab will be administrated at the beginning of entecavir prophylaxis. And in patients with high load of hepatitis B virus DNA(\>2000 IU/ml), rituximab will be administrated when hepatitis B virus DNA decreased to the level of 2000 IU/ml after entecavir prophylaxis.

Jun Zhu

Yuqin Song

Weijing Zhang

Liping Ye

Jingbo Wang

Mei Xue

Hui Liu

Yuankai Shi

Xiaoxiong Wu

Li Yu

Daobin Zhou

Hanyun Ren

Xiaojun Huang

Xiaoyan Ke

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

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.

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

Peking University

Peking University Cancer Hospital & Institute

Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy.

Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.

Entecavir 0.5mg daily from day 1 of antitumor therapy to at least 6 months after completing antitumor therapy

Observation arm

The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma.

The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma are randomized into entecavir prophylaxis group or observation group. In entecavir prophylaxis group, entecavir 0.5 mg/day orally is initiate on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy. In observation group, entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.

Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prophylactic Use of Entecavir for Non-Hodgkin's Lymphoma Patients With Resolved Hepatitis B	NCT00926757	Non Hodgkin's L... Hepatitis B	Entecavir proph... Therapeutic ent...	16 Years -	Taipei Veterans General Hospital, Taiwan
Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy	NCT01768195	Hepatitis B	Entecavir proph...	18 Years -	Peking University
Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy	NCT01768195	Hepatitis B	Entecavir proph...	18 Years -	Peking University
Prophylactic Use of Entecavir for Non-Hodgkin's Lymphoma Patients With Resolved Hepatitis B	NCT00926757	Non Hodgkin's L... Hepatitis B	Entecavir proph... Therapeutic ent...	16 Years -	Taipei Veterans General Hospital, Taiwan
Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma	NCT01765231	Hepatitis B	Entecavir proph... Observation arm	18 Years -	Peking University

Spots Global Cancer Trial Database for entecavir prophylaxis