Effect of Letermovir Prophylaxis on CMV-specific Immune Reconstitution Post UCBT

Cytomegalovirus Infection Reactivation Clinical Trial

Official title:

Effect of Letermovir Prophylaxis on Cytomegalovirus-specific Immune Reconstitution Post Unrelated Cord Blood Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06441669
• Other study ID #: CBCMV001
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: May 20, 2026

Study information

• Verified date: May 2024
• Source: Anhui Provincial Hospital
• Contact: Xiaoyu Zhu, ph.D
• Phone: 15255456091
• Email: xiaoyuz[@]ustc.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To explore the effect of letermovir prophylaxis on cytomegalovirus-specific immune reconstitution post unrelated cord blood transplantation

Description:

To explore the effect of letermovir prophylaxis on cytomegalovirus-specific and other lymphocyte subsets immune reconstitution post unrelated cord blood transplantation, and to analyze the potential mechanism and risk factors of late CMV reactivation after letermovir discontinuation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 20, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients are receiving a first unrelated cord blood transplantation (UCBT).

• Patients start letemovir prophylaxis within 0-28 days post UCBT.

Exclusion Criteria:

• Patients having active CMV DNAemia at the time of letermovir initiation.

• Patients recruited in a clinical study on an anti-CMV trial.

Related Conditions & MeSH terms

• Cytomegalovirus Infection Reactivation
• Cytomegalovirus Infections

Intervention

Drug:
• Letermovir
Patients will be given Letermovir with a recommended dose from +1 day to +100 days after UCBT.

Locations

Country	Name	City	State
China	Anhui Provincial Hospital	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of immune cells in peripheral blood	PBMCs from UCBT recipients were collected at 1 month, 2 month, 3 month, and 6 month and 12 month after HSCT, and tested for CMV-specific T cells, NK cells, T cells and other subsets.	one year
Primary	CMV DNAemia	CMV DNAemia is defined as the detection of CMV DNA in samples of plasma, whole blood or isolated peripheral blood leukocyte.	one year
Primary	Incidence of refractory CMV infection	Refractory CMV infection is defined as CMV viral load remaining at the same level or increasing despite appropriately doses of antiviral therapy for at least 2 weeks	one year
Primary	late CMV reactivation	Late CMV reactivation is defined as reactivation that occurs 100 days post UCBT, which means reactivation after discontinuing LET prophylaxis.	one year
Secondary	Treatment-ralated mortality	Treatment-ralated mortality	one year
Secondary	Incidence of other viral infection and viral-associated disease	Other viral infection and viral-associated diseases including EBV, ADV, HHV-6, BKV and HSV	one year
Secondary	Overall survival	Overall survival	one year
Secondary	serum immunoglobulin assay	The serum levels of IgG, IgM, and IgA were measured	1,3,6,9 month post UCBT