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Recruiting NCT07688759

CMV-CMI in csCMVi After HSCT

— Observational Cytomegalovirus Infections Hematopoietic Stem Cell Transplantation (HSCT) Immune Reconstitution

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anti-Cytomegalovirus Therapy.
Who it may be relevant to
Registry conditions: Cytomegalovirus Infections, Hematopoietic Stem Cell Transplantation (HSCT), Immune Reconstitution. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Study of CMV Specific Immune Reconstitution in Patients With Clinical Significant CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

Overview

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.

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.

Primary outcome measures

  • CMV-specific T cells [Time frame: from baseline to 4 weeks after end of treatment, an average of 8 weeks]
Secondary outcome measures (5)
  • Cumulative incidence of refractory CMV infection [Time frame: From Day 1 (first anti-CMV dose) through EOT (inclusive), an average of 4 weeks]
  • Cumulative incidence of CMV disease [Time frame: From EOT+1 day through 12 weeks after EOT(end of follow-up)]
  • Cumulative incidence of recurrent CMV infection [Time frame: From EOT+1 day through 12 weeks after EOT (end of follow-up)]
  • Cumulative incidence of acute graft-versus-host disease (aGVHD) [Time frame: From Day 1 through 12 weeks after EOT (end of follow-up)]
  • Overall survival [Time frame: From Day 1 through 12 weeks after EOT (end of follow-up).]

Eligibility criteria

Inclusion criteria

  • ≥18 years old and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT);
  • First CMV reactivation after transplantation;
  • Life expectancy of ≥8 weeks;
  • The participant (or legally acceptable representative, if applicable) has provided written informed consent for the trial.

Exclusion criteria

  • Recurrence of CMV infection;
  • primary CMV infection in CMV-seronegative recipients (R-);
  • Resistance to known anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, maribavir, etc.);
  • Currently receiving CMV-CTL treatment or lymphocyte infusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT07688759 · CMV-CMI in csCMVi

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗