EBV-positive diffuse large B-cell lymphoma (EBV+ DLBCL)
Conditions
Interventions
Experimental group:Tislelizumab combined with R-CHOP
Sponsors
Fudan University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 76 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-76 years. 2. ECOG PS score: 0-2. 3. Histopathologically confirmed, newly treated diffuse large B-cell lymphoma (DLBCL) NOS, and EBER positive (cut-off value 20%). 4. At least one measurable lesion. Lymph node lesions: long diameter >= 1.5 cm; extranodal lesions: long diameter >= 1.0 cm. 5. Have adequate organ function: (1) Blood system: absolute neutrophil count (ANC) >= 1.0x10^9/L, platelet count (PLT) >=75x10^9/L, if the peripheral blood index is abnormal due to lymphoma invading the bone marrow or spleen, the investigator can judge whether it is suitable for enrollment; (2) Coagulation INR= 50%; (4) Liver function: total bilirubin = 60 mL/min (for Cr > 1.5xULN (reference value of research unit), calculated by Cockcroft-Gault formula). 6. Patients in childbearing period agree to take appropriate contraceptive measures. Women of childbearing age had negative urine or serum pregnancy tests within 3 days prior to enrollment. 7. Be able to understand and sign the informed consent form and agree to long-term follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with known known severe hypersensitivity to any component of the treatment regimen. 2. Heart disease with clinical symptoms, including: New York Heart Association (NYHA) class IV cardiac insufficiency, unstable angina, acute myocardial infarction within 6 months before screening, congestive heart failure, Q-Tc interval greater than 500ms. 3. Those who have undergone major (secondary or above) surgery within 3 weeks before treatment. 4. Suffering from other malignancies other than lymphoma or undergoing treatment, except for the following cases: (1) Have received treatment for the purpose of cure, and have no known active malignant tumor disease >=3 years before enrollment; (2) Basal cell carcinoma of the skin (except melanoma) that has received adequate treatment and has no signs of disease; (3) Carcinoma in situ of the cervix that has received adequate treatment and has no signs of disease. 5. Within 2 weeks before the study screening period, induction therapy required due to large tumor burden is allowed; If there are concomitant non-autoimmune diseases that require low-dose hormone therapy (prednisone tablets =1 (log10IU/ml); and other acquired, congenital immunodeficiency disease subjects, including but not limited to HIV infection. 11. Pregnant or lactating patients. 12. Patients who have received organ transplantation in the past (except for autologous hematopoietic stem cell transplantation). 13. Has severe active infection. 14. Have a history of severe neurological or psychiatric disorders, including dementia or epilepsy. 15. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results. 16. Patients deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease free survival;Event-free survival;Safety; | — |
Countries
China
Contacts
Public ContactCao Junning
Fudan University Cancer Hospital
Outcome results
None listed