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CMV-CMI in csCMVi After HSCT

Recruitingn/aAges 18 Years - anyAllThe First Affiliated Hospital of Soochow Universiโ€ฆ
NCT07688759 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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-ฮณ-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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. โ‰ฅ18 years old and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT); 2. First CMV reactivation after transplantation; 3. Life expectancy of โ‰ฅ8 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.
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What it tests

  • Anti-Cytomegalovirus Therapy
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Where

1 site
The First Affiliated Hospital of Soochow University
Suzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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