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

NCT ID: NCT06449586

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-06-01

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.

Conditions

Hematologic Malignancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CMI-F

Letemovir prophylaxis stops when CMV-FlowSpot \>1.5.

Group Type: EXPERIMENTAL

Letermovir

Intervention Type: DRUG

letermovir stops when CMI\>1.5

CMI-N

Letemovir prophylaxis stopos in the first 100 days after allo-HSCT.

Group Type: OTHER

Letermovir

Intervention Type: DRUG

letermovir stops when CMI\>1.5

Interventions

Letermovir

letermovir stops when CMI\>1.5

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hu Xiaoxia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai Liquan Hospital

Shanghai, , China

Countries

China

Other Identifiers

RJBMT-2024-02

Identifier Type: -

Identifier Source: org_study_id