CMV-specific T cells after CMV reactivation in adults after HSCT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, exploratory observational study will enroll 40 adult CMV-seropositive patients who experience their first CMV reactivation after allo-HSCT. CMV-specific T cell responses are measured by an ELISPOT assay targeting IE-1 and pp65 antigens at four time points: at CMV viremia diagnosis, three weeks after starting preemptive therapy, at drug withdrawal, and four weeks after stopping therapy. Patients will be followed for 12 weeks after treatment discontinuation. The study aims to describe how CMV-specific cell-mediated immunity changes during therapy and to explore associations with refractory or recurrent CMV infection. Interventions consist of standard anti-CMV therapy as clinically indicated. Eligibility requires adults ≥18 years who have undergone allo-HSCT, are experiencing first CMV reactivation, have a life expectancy ≥8 weeks, and provide informed consent. Exclusions include CMV recurrence, primary CMV infection in seronegative recipients, drug resistance, or current CMV-CTL or lymphocyte infusions. The lead sponsor is The First Affiliated Hospital of Soochow University, with participation limited to this site in Suzhou, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ≥18 years old and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT);
2. First CMV reactivation after transplantation;
3. Life expectancy of ≥8 weeks;
4. The participant (or legally acceptable representative, if applicable) has provided written informed consent for the trial.

Exclusion Criteria:

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

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Feng Chen, MD
• Email: 13584861215@163.com
• Phone: +8613584861215

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.