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Trial Title:
Clinical Study of Donor EBV-CTL Infusion in Patients With CAEBV and EBV-HLH After Allo-HSCT
NCT ID:
NCT05532826
Condition:
Chronic Active Epstein-Barr Virus Infection
Virus-Associated Hemophagocytic Syndrome
Conditions: Official terms:
Epstein-Barr Virus Infections
Lymphohistiocytosis, Hemophagocytic
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
donor EBV-specific T lymphocytes
Description:
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.
Arm group label:
EBV-CTL infusion patients
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)
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhao Wang
Address:
City:
Beijing
Zip:
100050
Country:
China
Status:
Recruiting
Contact:
Last name:
zhao wang, MD
Phone:
8601063138303
Email:
wangzhao@ccmu.edu.cn
Start date:
October 8, 2022
Completion date:
September 15, 2024
Lead sponsor:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Beijing Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05532826
