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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)
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBV-CTL infusion patients | Experimental | Given donor EBV-CTL infusion after allo HSCT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| donor EBV-specific T lymphocytes | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| EBV-DNA | EBV-DNA negative conversion rate for patients with relapse/non-remission and EBV-DNA reactivation rate for high-risk patients | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhao wang, MD | Contact | 86010631383803 | wangzhao@ccmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| zhao wang, MD | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhao Wang | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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