Effect of Letermovir Prophylaxis on CMV-specific Immune Reconstitution Post UCBT
- Registration Number
- NCT06441669
- Lead Sponsor
- Anhui Provincial Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Patients are receiving a first unrelated cord blood transplantation (UCBT).
- Patients start letemovir prophylaxis within 0-28 days post UCBT.
- Patients having active CMV DNAemia at the time of letermovir initiation.
- Patients recruited in a clinical study on an anti-CMV trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description letermovir group Letermovir 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.
- Primary Outcome Measures
Name Time Method 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.
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
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.
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China