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.
≥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.
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.
The study population consists of CMV-seropositive adults (≥18 years of age) who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) and experience their first CMV reactivation after transplantation.
Cohort
Prospective
Anti-Cytomegalovirus Therapy
DrugThe 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.
CMV-specific T cells
Number of IFN-γ-producing T cells per 250,000 PBMCs measured by ELISPOT
Cumulative incidence of refractory CMV infection
Cumulative incidence of CMV disease
Cumulative incidence of recurrent CMV infection
Cumulative incidence of acute graft-versus-host disease (aGVHD)
Cumulative incidence of non-relapse mortality (NRM)
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