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

Last updated: January 7, 2025
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hematologic Neoplasms

Blood Cancer

Treatment

Letermovir

Clinical Study ID

NCT06449586
RJBMT-2024-02
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 stemcell transplantation;

  • Second transplantation;

  • Combination of immunodeficiency diseases;

  • Those judged by the investigator to be unsuitable for participation in this trial.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Letermovir
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • Tongji Hospital of Huazhong University of Science and Technology, Wuhan

    Wuhan, Hubei
    China

    Active - Recruiting

  • Ruijin Hospital of Shanghai Jiaotong University

    Shanghai, Shanghai
    China

    Active - Recruiting

  • The First Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Ruijin Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Liquan Hospital

    Shanghai,
    China

    Active - Recruiting

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