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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
250
letermovir stops when CMI\>1.5
Tongji Hospital of Huazhong University of Science and Technology, Wuhan
Wuhan, Hubei, China
Ruijin Hospital of Shanghai Jiaotong University
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
Incidence of late-onset clinical significant CMV (cs-CMV) infection
Incidence of late-onset clinical significant CMV (cs-CMV) infection
Time frame: through study completion, an average of 1 year
cumulative incidence of cs-CMV infection
cumulative incidence of cs-CMV infection
Time frame: through study completion, an average of 1 year
overall survival
overall survival
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Shanghai Liquan Hospital
Shanghai, China