Hematologic Malignancy
Conditions
Brief summary
To evaluate the efficacy of CMV-specific T cell immunity test in prolonged usage of letermovir for avoiding late-onset csCMVi after all-HSCT.
Detailed description
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.
Interventions
DRUGLetermovir
letermovir stops when CMI\>1.5
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* first allogeneic hematopoietic stem cell transplantation; * 18-70 years old; * use cytomegalovirus prophylaxis with letemovir after allo-HSCT; * CMV Ig G D+/R+;
Exclusion criteria
* Allergy, known hypersensitivity to letermovir tablet or injection components; * CMV DNAemia within six months before transplantation or previous CMV disease; * Presence of organ failure and inability to tolerate allogeneic hematopoietic stem cell transplantation; * Second transplantation; * Combination of immunodeficiency diseases; * Those judged by the investigator to be unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of late-onset clinical significant CMV (cs-CMV) infection | through study completion, an average of 1 year | Incidence of late-onset clinical significant CMV (cs-CMV) infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cumulative incidence of cs-CMV infection | through study completion, an average of 1 year | cumulative incidence of cs-CMV infection |
| overall survival | through study completion, an average of 1 year | overall survival |
Countries
China
Outcome results
None listed