Clinical trial NCT06449586: CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After All-HSCT
Official title: CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of late-onset clinical significant CMV (cs-CMV) infection
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: cumulative incidence of cs-CMV infection
timeFrame: through study completion, an average of 1 year
measure: overall survival
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital of Huazhong University of Science and Technology, Wuhan
state: Hubei
city: Shanghai
country: China
facility: Ruijin Hospital of Shanghai Jiaotong University
state: Shanghai
city: Hangzhou
country: China
facility: The First Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai JiaoTong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Liquan Hospital
Study officials:
References: