Chronic Active Epstein-Barr Virus Infection, Virus-Associated Hemophagocytic Syndrome
Conditions
Brief summary
To evaluate the efficacy and safety of donor EBV-specific T lymphocytes (EBV-CTL) infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Detailed description
Evaluate the efficacy and safety of donor EBV-specific T lymphocytes (EBV-CTL) infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Interventions
OTHERdonor EBV-specific T lymphocytes
EBV-DNA reactive after transplantation, or did not turn negative after +30 days, peripheral blood lymphocytes of the donor were collected to prepare EBV-CTL, and the first transfusion of EBV-CTL 6.0x105 was given at 48h to rapidly culture EBV-CTL, then EBV-CTL 6.0x105/kg was injected once a week untile EBV-DNA negative for 2 consecutive times or GVHD happened. After the second infusion, EBV-DNA did not decrease and there was no aGVHD patients, EBV-CTL infusion volume was increased to 1.2x106/kg, once a week. After 2 cycle infusion, EBV-DNA still did not decrease, and the reinfusion was terminated. Peripheral blood lymphocytes were collected from donors of high-risk patients at +14 days after allogeneic hematopoietic stem cell transplantation to prepare EBV-CTL, and EBV-CTL 6.0x105/kg was infused at +21d, +28d, +35d and + 42D for prevention. During treatment, if the patient develops GVHD, the infusion should be stopped.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with CAEBV or EBV-HLH who were eligible for allogeneic hematopoietic stem cell transplantation agreed to regular monitoring of EBV-DNA after transplantation. 2. Age ≤65 years old, ECOG score 0-2. 3. Organ function: Cardiac EF≥40%, creatinine clearance ≥50%, aminotransferase (ALT/AST) \< 200U/L. 4. The estimated survival time is more than 3 months. 5) Have donors who meet the requirements of allogeneic hematopoietic stem cell transplantation donors， and the donor agreed to collect lymphocytes to prepare EBV-CTL
Exclusion criteria
1. The patient or donor had a New York Heart Association (NYHA) score of grade II or higher (including grade II). Or a definite diagnosis of cirrhosis. 2. There are active infections other than EBV that have not yet been controlled. 3. The donor has a blood-borne infectious disease (e.g. HIV, hepatitis B, hepatitis C, syphilis, etc.). The patient was positive for HBV-DNA or HCV-RNA. 4. Active major hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.). 5. The donor refused to collect lymphocytes to prepare EBV-CTL cells, or the number of EBV-CTL cells prepared from the donor did not meet the infusion requirements. 6. At the same time participate in other clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EBV-DNA | 1 year | EBV-DNA negative conversion rate for patients with relapse/non-remission and EBV-DNA reactivation rate for high-risk patients |
Countries
China
Contacts
Primary Contactzhao wang, MD
Outcome results
None listed