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

CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After Allogeneic Hematopoietic Stem Cell Transplantation

To evaluate the efficacy of CMV-specific T cell immunity test in prolonged usage of letermovir for avoiding late-onset csCMVi after all-HSCT.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Drug: Letermovir

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China
    • Shanghai Liquan Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital of Huazhong University of Science and Technology, Wuhan
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Ruijin Hospital of Shanghai Jiaotong University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CMI-F; Letemovir prophylaxis stops when CMV-FlowSpot >1.5.	Drug: Letermovir; letermovir stops when CMI>1.5
Other: CMI-N; Letemovir prophylaxis stopos in the first 100 days after allo-HSCT.	Drug: Letermovir; letermovir stops when CMI>1.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of late-onset clinical significant CMV (cs-CMV) infection	Incidence of late-onset clinical significant CMV (cs-CMV) infection	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	overall survival	through study completion, an average of 1 year
cumulative incidence of cs-CMV infection	cumulative incidence of cs-CMV infection	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 1, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Poly(ADP-ribose) Polymerase Inhibitors; Anti-Infective Agents; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antiviral Agents; letermovir
• Other Study ID Numbers: RJBMT-2024-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No