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To explore the effect of letermovir prophylaxis on cytomegalovirus-specific immune reconstitution post unrelated cord blood transplantation
To explore the effect of letermovir prophylaxis on cytomegalovirus-specific and other lymphocyte subsets immune reconstitution post unrelated cord blood transplantation, and to analyze the potential mechanism and risk factors of late CMV reactivation after letermovir discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| letermovir group | Patients will be given Letermovir with a recommended dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine or according to clinical instructions) from +1 day to +100 days after UCBT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letermovir | Drug | Patients will be given Letermovir with a recommended dose from +1 day to +100 days after UCBT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of immune cells in peripheral blood | PBMCs from UCBT recipients were collected at 1 month, 2 month, 3 month, and 6 month and 12 month after HSCT, and tested for CMV-specific T cells, NK cells, T cells and other subsets. | one year |
| CMV DNAemia | CMV DNAemia is defined as the detection of CMV DNA in samples of plasma, whole blood or isolated peripheral blood leukocyte. | one year |
| Incidence of refractory CMV infection | Refractory CMV infection is defined as CMV viral load remaining at the same level or increasing despite appropriately doses of antiviral therapy for at least 2 weeks | one year |
| late CMV reactivation | Late CMV reactivation is defined as reactivation that occurs 100 days post UCBT, which means reactivation after discontinuing LET prophylaxis. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-ralated mortality | Treatment-ralated mortality | one year |
| Incidence of other viral infection and viral-associated disease | Other viral infection and viral-associated diseases including EBV, ADV, HHV-6, BKV and HSV |
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Inclusion Criteria:
Exclusion Criteria:
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The study consists 60 cases recipients of UCBT. All patients will receive letermovir prophylaxis within 0-28 days post UCBT.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyu Zhu, ph.D | Contact | 15255456091 | xiaoyuz@ustc.edu.cn | |
| Bingbing Yan | Contact | 15993691727 | bing0415@mail.ustc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoyu Zhu, ph.D | The First Affiliated Hospital of University of Science and Technology of China (Anhui Provicial Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Recruiting | Hefei | Anhui | China |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000588473 | letermovir |
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| one year |
| Overall survival | Overall survival | one year |
| serum immunoglobulin assay | The serum levels of IgG, IgM, and IgA were measured | 1,3,6,9 month post UCBT |