Diffuse Large B-Cell Lymphoma
Conditions
Interventions
Test group:Tenofovir Disoproxil Fumarate: 300 mg, orally, once daily
Sponsors
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) according to the 2016 WHO classification of hematopoietic and lymphoid tumors. 2. Presence of high-risk factors for Hepatitis B Virus (HBV) reactivation, defined as meeting any of the following criteria: (1) HBsAg carriers (i.e., HBeAg negative with undetectable HBV DNA); (2) Occult HBV infection (i.e., negative HBV serum immunological markers but positive for serum or liver tissue HBV DNA); (3) Serum HBsAg negative but anti-HBc positive; (4) Chronic HBV carriers in the immune-tolerant phase (i.e., with active HBV DNA replication, normal alanine aminotransferase (ALT) levels, and no evidence of hepatic inflammatory response). 3. Age >=18 years and =30 mL/min. Coagulation function: International Normalized Ratio (INR) and Prothrombin Time (PT) <=1.5 × ULN. Note: Patients not meeting the above laboratory criteria may be considered for enrollment after supportive treatment, as judged by the investigator. 9. The patient (or their legally authorized representative) has provided written informed consent, is able to understand the study procedures, and is willing to comply with the protocol-specified visits and procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with known allergy, resistance, or intolerance to any drug in the treatment regimen, as determined by the investigator. 2. Administration of any investigational drug or radiotherapy within 4 weeks prior to enrollment. 3. Having undergone major surgical procedures within 4 weeks prior to enrollment. 4. Presence of severe active infection within 4 weeks, which, in the investigator's judgment, renders the patient unsuitable for chemotherapy. 5. History of stroke or intracranial hemorrhage within 3 months; or patients with active Grade 3 or higher gastrointestinal bleeding. 6. Pregnancy or lactation. 7. Impaired cardiac function or significant cardiac disease, including but not limited to: (1) Myocardial infarction, congestive heart failure, or viral myocarditis within 6 months prior to screening; (2) Symptomatic heart disease requiring therapeutic intervention, such as unstable angina or arrhythmia; (3) Cardiac function classified as NYHA Class II-IV; (4) Left ventricular ejection fraction (LVEF) < 50% or below the lower limit of normal as defined by the research center, measured by echocardiography. 8. Known history of HIV infection, primary immunodeficiency, or active tuberculosis. 9. Patients with uncontrolled hypertension or diabetes mellitus. 10.Patients with active Hepatitis C virus (HCV) infection. (Note: Subjects who are HCV antibody-positive may be enrolled if HCV RNA is undetectable). 11. History of other malignancies, except for appropriately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, in situ carcinoma of the gastrointestinal mucosa, or localized prostate cancer, which, in the investigator's opinion, could interfere with the implementation of the protocol or interpretation of results. 12. Active psychiatric disorder, alcohol abuse, drug abuse, or substance dependence. 13. Any other condition that, in the judgment of the investigator, would make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reactivation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactLei Fan
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed