Cytomegalovirus Infection Reactivation
Conditions
Keywords
Cytomegalovirus Infection, Umbilical Cord Blood Transplantation, CMV-Specific Immune Reconstitution, Letermovir
Brief summary
To explore the effect of letermovir prophylaxis on cytomegalovirus-specific immune reconstitution post unrelated cord blood transplantation
Detailed description
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.
Interventions
DRUGLetermovir
Patients will be given Letermovir with a recommended dose from +1 day to +100 days after UCBT.
Sponsors
Anhui Provincial Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients are receiving a first unrelated cord blood transplantation (UCBT). * Patients start letemovir prophylaxis within 0-28 days post UCBT.
Exclusion criteria
* Patients having active CMV DNAemia at the time of letermovir initiation. * Patients recruited in a clinical study on an anti-CMV trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late CMV reactivation | one year | Late CMV reactivation is defined as reactivation that occurs 100 days post UCBT, which means reactivation after discontinuing LET prophylaxis. |
| Numbers of immune cells in peripheral blood | one year | 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. |
| CMV DNAemia | one year | CMV DNAemia is defined as the detection of CMV DNA in samples of plasma, whole blood or isolated peripheral blood leukocyte. |
| Incidence of refractory CMV infection | one year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-ralated mortality | one year | Treatment-ralated mortality |
| Incidence of other viral infection and viral-associated disease | one year | Other viral infection and viral-associated diseases including EBV, ADV, HHV-6, BKV and HSV |
| Overall survival | one year | Overall survival |
| serum immunoglobulin assay | 1,3,6,9 month post UCBT | The serum levels of IgG, IgM, and IgA were measured |
Countries
China
Contacts
Primary ContactXiaoyu Zhu, ph.D
Backup ContactBingbing Yan
Outcome results
None listed