CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After All-HSCT

Not Applicable

Recruiting

• Conditions: Hematologic Malignancy
• Interventions: Drug: Letermovir

• Registration Number: NCT06449586
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study First Submitted: 2024-06-01
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-10
• Study Start: 2024-07-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CMI-F	Letermovir	Letemovir prophylaxis stops when CMV-FlowSpot \>1.5.
CMI-N	Letermovir	Letemovir prophylaxis stopos in the first 100 days after allo-HSCT.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Tongji Hospital of Huazhong University of Science and Technology, Wuhan; 🇨🇳 Wuhan, Hubei, China

Ruijin Hospital of Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China

The First Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Ruijin Hospital, Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, China

Shanghai Liquan Hospital; 🇨🇳 Shanghai, China