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To evaluate the efficacy of CMV-specific T cell immunity test in prolonged usage of letermovir for avoiding late-onset csCMVi after all-HSCT.
Reactivation of cytomegalovirus (CMV) leads to significant morbidity and mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Letermovir (LTV) has substantially reduced the risk of clinically significant CMV infection (csCMVi) in CMV seropositive recipients of allo-HSCT. LTV discontinuation after day 100 (d100) has been reported to increase the risk of late-onset csCMVi, causing by impaired reconstitution of CMV-specific T immunity. The investigator sought to decrease the probability of CS-CMVi after letermovir withdrawal. Restoration of CMV-specific T cells is imperative for effective control of CMV reactivation following allo-HSCT. Letermovir has been found impending recovery of CMV-specific T immunity. The investigators' retrospective study has proved that lower CMV-specific CD4+ T cells (<2.01 cells/µL) at week 8 increased the risk of late-onset CMV reactivation (50.0%) compared to the higher ones (7.69%, p=0.04) in letermovir prophylaxis. Thus, the guidance of CMV-specific cell immunity is recommended in letermovir prophylaxis.
Therefore, the investigator conduct a multicenter, randomized, controlled study based on retrospective research to further explore and validate the efficacy of CMV-specific T cell immunity test guiding the prolonged usage of letermovir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMI-F | Experimental | Letemovir prophylaxis stops when CMV-FlowSpot >1.5. |
|
| CMI-N | Other | Letemovir prophylaxis stopos in the first 100 days after allo-HSCT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letermovir | Drug | letermovir stops when CMI>1.5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of late-onset clinical significant CMV (cs-CMV) infection | Incidence of late-onset clinical significant CMV (cs-CMV) infection | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| cumulative incidence of cs-CMV infection | cumulative incidence of cs-CMV infection | through study completion, an average of 1 year |
| overall survival | overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital of Huazhong University of Science and Technology, Wuhan | Wuhan | Hubei | China | |||
| Ruijin Hospital of Shanghai Jiaotong University |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000588473 | letermovir |
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| through study completion, an average of 1 year |
| Shanghai |
| Shanghai Municipality |
| China |
| The First Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Ruijin Hospital, Shanghai JiaoTong University School of Medicine | Shanghai | China |
| Shanghai Liquan Hospital | Shanghai | China |