Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir prophylaxis | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir prophylaxis | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis | from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of hepatitis B virus virological response | from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy | |
| the incidence of hepatitis B virus serological response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Zhu | Contact | zj@bjcancer.org | ||
| Yuqin Song | Contact | songyuqin622@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Zhu | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital & Institute | Recruiting | Beijing | Beijing Municipality | 100142 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy |
| the incidence of hepatitis B virus maintained response | from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy |
| the incidence of hepatitis B virus sustained response | from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy |
| the incidence of hepatitis B virus relapse and relapse related hepatitis | from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy |
| 307 Hospital of the Chinese People's Liberation Army | Recruiting | Beijing | Beijing Municipality | China |
|
| 309 Hospital of the Chinese People's Liberation Army | Recruiting | Beijing | Beijing Municipality | China |
|
| Aerospace Central Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| Air Force General Hospital of the Chinese People's Liberation Army | Recruiting | Beijing | Beijing Municipality | China |
|
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| Cancer Institute & Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
|
| First Hospital affiliated to General Hospital of the Chinese People's Liberation Army | Recruiting | Beijing | Beijing Municipality | China |
|
| General Hospital of Chinese People's Liberation Army | Recruiting | Beijing | Beijing Municipality | China |
|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C413685 | entecavir |
Not provided
Not provided
Not provided