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Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.
Investigators will dynamically monitor the CMV-specific cellular immune reconstitution after HSCT，and analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.
Investigators will collect peripheral blood at 1 month, 2 month, 3 month, and 6 month after HSCT from the participated patients, and dynamically monitor the CMV-specific T and NK cellular immune reconstitution.
Investigators will also analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letermovir Group | HSCT recipients who received letermovir prophylaxis |
| |
| Preemptive therapy Group | HSCT recipients who received PCR-guided preemptive therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letermovir | Drug | Patients received letermovir as prophylaxis or received preemptive therapy for CMV depends on clinical needs and patients' wishes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically significant CMV infection (CSI) | Clinically significant CMV infection (CSI) is defined as the administration of antiviral therapy as preemptive therapy for CMV DNAemia or treatment for CMV disease. | 6 months after HSCT |
| Incidence of refractory CMV infection and CMV disease | Refractory CMV infection is defined as a persistent viral load (CMV viral load at the same level or higher than the peak viral load within 1 week but <1 log10 increase in CMV DNA titers done in the same laboratory and with the same assay) after at least 2 weeks of appropriately dosed antiviral therapy. | 6 months after HSCT |
| Numbers of immune cells in peripheral blood | PBMCs from HSCT recipients were collected at 1 month, 2 month, 3 month, and 6 month after HSCT, and tested for NK cells, T cells, CMV-specific T cells and their subsets. | 6 months after HSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-ralated mortality | Treatment-ralated mortality | Through study completion, an average of 1 year |
| Overall survival | Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients who received allogeneic HSCT.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | 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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| Through study completion, an average of 1 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 | 6 months after HSCT |
| People's Hospital of Peking University |
| Beijing |
| China |