chronic active Epstein-Barr virus infection
Conditions
Interventions
Treatment Group:PD-1 monoclonal antibody
Sponsors
Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients join this study voluntarily, and must sign an informed consent form before all specific research procedures begin. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the patient's immediate family will sign the informed consent form; 2. Aged 18 to 70 years old (including 18 and 70 years old), both male and female; 3. The following three clinical manifestations appear: (1) IM-like symptoms persist or recur for more than 3 months; (2) Evidence of EBV infection and histopathological damage: such as increased EBV DNA levels in peripheral blood; (3) The above clinical manifestations caused by autoimmune diseases, neoplastic diseases and immunodeficiency diseases are excluded; patients who can be diagnosed as chronic active EBV infection; 4. The patient's main tissues and organs function well (within 7 days before the start of study treatment): (1) Liver function: ALT/AST =95%; (4) Cardiac function: Left ventricular ejection fraction (LVEF) >= 40%. 5. Subjects must complete all screening assessments listed in the trial protocol; 6. The patient's peripheral superficial venous blood flow is smooth, which can meet the needs of blood infusion; 7. Patients with ECOG score =3 months.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant (positive urine/blood pregnancy test) or breastfeeding; Men or women who have planned to have children in the next year; Or patients can not guarantee to take effective contraceptive measures (condoms or birth control pills, etc.) within 1 year after enrollment; 2. There are malignant tumors of other systems requiring treatment; 3. Patients with hemophagocytic syndrome (HLH) and mutations of high-risk genes (DDX3X, PRF1, UNC13D, STX11, STXBP2, Rab27a, LYST, SH2D1A, BIRC4, ITK, AP3 beta 1, MAGT1, CD27, etc.) were excluded; 4. Patients had uncontrollable infectious diseases within 4 weeks before enrollment; 5. Severe organ failure or myocardial infarction within the last 6 months; 6. HIV-infected persons; Or have a serious autoimmune disease or immune deficiency disease; 7. The patient was allergic to PD-1 monoclonal antibody and other drugs; 8. Suffering from mental illness; 9. The patient has substance abuse/addiction; 10. According to the researchers' judgment, the patients have other conditions that are not suitable for inclusion, such as alcohol abuse, other serious diseases requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EBV DNA copies in peripheral blood; | — |
Countries
China
Contacts
Public ContactZheng Miao
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed