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

NCT06449586 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: RJBMT-2024-02
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 5

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.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• cumulative incidence of cs-CMV infection

  through study completion, an average of 1 year

• overall survival

  through study completion, an average of 1 year

Study Arms (2)

CMI-F

EXPERIMENTAL

Letemovir prophylaxis stops when CMV-FlowSpot \>1.5.

Drug: Letermovir

CMI-N

OTHER

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

Drug: Letermovir

Interventions

Letermovir DRUG

letermovir stops when CMI\>1.5

CMI-F; CMI-N

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first allogeneic hematopoietic stem cell transplantation;
• years old;
• use cytomegalovirus prophylaxis with letemovir after allo-HSCT;
• CMV Ig G D+/R+;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (5)

Tongji Hospital of Huazhong University of Science and Technology, Wuhan

Wuhan, Hubei, China

Location

Ruijin Hospital of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Location

The First Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, China

Location

Shanghai Liquan Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

letermovir

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 10, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CN (5)