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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cytomegalovirus Infection Reactivation
• Intervention / Treatment: Drug: Letermovir

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Xiaoyu Zhu, Ph.D; Phone Number: 15255456091; Email: xiaoyuz@ustc.edu.cn
• Study Contact Backup: Name: Bingbing Yan; Phone Number: 15993691727; Email: bing0415@mail.ustc.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • Anhui Provincial Hospital
      • Contact: Xiaoyu Zhu, Ph.D; Phone Number: 15255456091; Email: xiaoyuz@ustc.edu.cn
      • Contact: Bingbing Yan; Phone Number: 15993691727; Email: bing0415@mail.ustc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study consists 60 cases recipients of UCBT. All patients will receive letermovir prophylaxis within 0-28 days post UCBT.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
letermovir group; Patients will be given Letermovir with a recommended dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine or according to clinical instructions) from +1 day to +100 days after UCBT.	Drug: Letermovir; Patients will be given Letermovir with a recommended dose from +1 day to +100 days after UCBT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-ralated mortality	Treatment-ralated mortality	one year
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
Overall survival	Overall survival	one year
serum immunoglobulin assay	The serum levels of IgG, IgM, and IgA were measured	1,3,6,9 month post UCBT

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Principal Investigator: Xiaoyu Zhu, ph.D, The First Affiliated Hospital of University of Science and Technology of China (Anhui Provicial Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Estimated): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Letermovir; Cytomegalovirus Infection; Umbilical Cord Blood Transplantation; CMV-Specific Immune Reconstitution
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections; Latent Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Letermovir
• Other Study ID Numbers: CBCMV001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No