Effect of Letermovir Prophylaxis on Cytomegalovirus-specific Immune Reconstitution Post Unrelated Cord Blood Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- late CMV reactivation
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: Letermovir (Drug)
Outcomes
Primary Outcomes
late CMV reactivation
Time Frame: one year
Late CMV reactivation is defined as reactivation that occurs 100 days post UCBT, which means reactivation after discontinuing LET prophylaxis.
CMV DNAemia
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Overall survival(one year)
- serum immunoglobulin assay(1,3,6,9 month post UCBT)
- Treatment-ralated mortality(one year)
- Incidence of other viral infection and viral-associated disease(one year)