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

NCT06441669 | Recruiting

• 1 other identifier: CBCMV001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cytomegalovirus Infection Reactivation

Keywords

Cytomegalovirus Infection; Umbilical Cord Blood Transplantation; CMV-Specific Immune Reconstitution; Letermovir

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Treatment-ralated mortality

  one year

• Incidence of other viral infection and viral-associated disease

  one year

• Overall survival

  one year

• serum immunoglobulin assay

  1,3,6,9 month post UCBT

Study Arms (1)

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

Interventions

Letermovir DRUG

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

letermovir group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients are receiving a first unrelated cord blood transplantation (UCBT).
• Patients start letemovir prophylaxis within 0-28 days post UCBT.

You may not qualify if:

• Patients having active CMV DNAemia at the time of letermovir initiation.
• Patients recruited in a clinical study on an anti-CMV trial.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

letermovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Xiaoyu Zhu, ph.D

  The First Affiliated Hospital of University of Science and Technology of China (Anhui Provicial Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyu Zhu, ph.D

CONTACT

15255456091; xiaoyuz@ustc.edu.cn

Bingbing Yan

CONTACT

15993691727; bing0415@mail.ustc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 20, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-05

Locations

CN (1)