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CMV-CMI in csCMVi After HSCT

NCT07688759 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-07-07

No results posted yet for this study

Summary

Cytomegalovirus (CMV) reactivation is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT), and the reconstitution of CMV-specific cell-mediated immunity (CMV-CMI) plays a key role in viral control.

This prospective, exploratory study will enroll 40 adult CMV-seropositive patients who experience their first CMV reactivation after allo-HSCT. CMV-specific T cell levels (IFN-γ-producing T cells stimulated by IE-1 and pp65 antigens) will be measured using ELISPOT at four time points: at diagnosis of CMV viremia, 3 weeks after initiating preemptive therapy, at anti-CMV drug withdrawal, and 4 weeks after treatment discontinuation. Patients will be followed for 12 weeks after stopping treatment.

The primary objective is to describe the changes in CMV-specific T cell levels over the therapy. Secondary objectives are to explore the relationship between these levels and the occurrence of refractory CMV infection, recurrent CMV infection, and CMV disease. Findings may help identify patients at high risk of progressing to severe or persistent CMV infection at an early stage of preemptive therapy, enabling personalized intervention strategies.

Conditions

  • Cytomegalovirus Infections
  • Hematopoietic Stem Cell Transplantation (HSCT)
  • Immune Reconstitution

Interventions

DRUG

Anti-Cytomegalovirus Therapy

The choice of agent (monotherapy or combination) is at the investigator's discretion and may include ganciclovir, valganciclovir, foscarnet, maribavir, or other approved anti-CMV medications.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-05-31
Completion
2028-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07688759 on ClinicalTrials.gov