Study of CMV Specific Immune Reconstitution in Patients With Clinical Significant CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- CMV-specific T cells
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
CMV-specific T cells
Time Frame: from baseline to 4 weeks after end of treatment, an average of 8 weeks
Number of IFN-γ-producing T cells per 250,000 PBMCs measured by ELISPOT
Secondary Outcomes
- Cumulative incidence of refractory CMV infection(From Day 1 (first anti-CMV dose) through EOT (inclusive), an average of 4 weeks)
- Cumulative incidence of CMV disease(From EOT+1 day through 12 weeks after EOT(end of follow-up))
- Cumulative incidence of recurrent CMV infection(From EOT+1 day through 12 weeks after EOT (end of follow-up))
- Cumulative incidence of acute graft-versus-host disease (aGVHD)(From Day 1 through 12 weeks after EOT (end of follow-up))
- Overall survival(From Day 1 through 12 weeks after EOT (end of follow-up).)