The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Location status: Recruiting
NCT Number: NCT07688759
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Suzhou, Jiangsu, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The 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.
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
Time frame: From Day 1 (first anti-CMV dose) through EOT (inclusive), an average of 4 weeks
Time frame: From EOT+1 day through 12 weeks after EOT(end of follow-up)
Time frame: From EOT+1 day through 12 weeks after EOT (end of follow-up)
Time frame: From Day 1 through 12 weeks after EOT (end of follow-up)
Time frame: From Day 1 through 12 weeks after EOT (end of follow-up).
Time frame: From Day 1 through 12 weeks after EOT (end of follow-up).
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital of Soochow University
Other
Study of CMV Specific Immune Reconstitution in Patients With Clinical Significant CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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