Clinical trial NCT01768195: Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy
Official title: Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B
Keywords: Lymphoma
Hepatitis B Virus
Therapeutic Uses
Antiviral Agents
rituximab
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis
timeFrame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
Secondary outcomes:
measure: the incidence of hepatitis B virus virological response
timeFrame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
measure: the incidence of hepatitis B virus serological response
timeFrame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
measure: the incidence of hepatitis B virus maintained response
timeFrame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
measure: the incidence of hepatitis B virus sustained response
timeFrame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
measure: the incidence of hepatitis B virus relapse and relapse related hepatitis
timeFrame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
city: Beijing
country: China
facility: 307 Hospital of the Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: 309 Hospital of the Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Aerospace Central Hospital
state: Beijing
city: Beijing
country: China
facility: Air Force General Hospital of the Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Institute & Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: First Hospital affiliated to General Hospital of the Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: General Hospital of Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu
role: PRINCIPAL_INVESTIGATOR
References: