CMV-CMI in csCMVi After HSCT (NCT07688759) | Clinical Trial Compass
RecruitingNot Applicable
CMV-CMI in csCMVi After HSCT
China40 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CMV-specific T cells
Timeframe: from baseline to 4 weeks after end of treatment, an average of 8 weeks
Trial details
NCT IDNCT07688759
SponsorThe First Affiliated Hospital of Soochow University