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

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449586
• Other study ID #: RJBMT-2024-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: June 2024
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. , first allogeneic hematopoietic stem cell transplantation;

2. , 18-70 years old;

3. , use cytomegalovirus prophylaxis with letemovir after allo-HSCT;

4. , CMV Ig G D+/R+;

Exclusion Criteria:

1. , Allergy, known hypersensitivity to letermovir tablet or injection components;

2. , CMV DNAemia within six months before transplantation or previous CMV disease;

3. , Presence of organ failure and inability to tolerate allogeneic hematopoietic stem cell transplantation;

4. , Second transplantation;

5. , Combination of immunodeficiency diseases;

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms

Intervention

Drug:
• Letermovir
letermovir stops when CMI>1.5

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of late-onset clinical significant CMV infection		through study completion, an average of 1 year
Secondary	CI of cs-CMV infection		through study completion, an average of 1 year
Secondary	overall survival		through study completion, an average of 1 year