CMV-CMI in csCMVi After HSCT
3. juli 2026 oppdatert av: The First Affiliated Hospital of Soochow University
Study of CMV Specific Immune Reconstitution in Patients With Clinical Significant CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
40
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Feng Chen, MD
- Telefonnummer: +8613584861215
- E-post: 13584861215@163.com
Studiesteder
-
-
Jiangsu
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Suzhou, Jiangsu, Kina
- Rekruttering
- The First Affiliated Hospital of Soochow University
-
Ta kontakt med:
- The First Affiliated Hospital of Soochow University
- Telefonnummer: +86 512 67972861
- E-post: sdfyec@163.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The study population consists of CMV-seropositive adults (≥18 years of age) who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) and experience their first CMV reactivation after transplantation.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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CMV Reactivation Cohort
Adult CMV-seropositive patients (≥18 years) who experience first CMV reactivation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Therapy with anti-CMV drugs (mono- or combination therapy, at investigator's discretion) is initiated upon diagnosis of CMV viremia and continued until two consecutive negative CMV DNA tests separated by ≥5 days.
CMV-specific T cell levels are measured by ELISPOT at four time points: at CMV viremia diagnosis, 3 weeks after starting preemptive therapy, at anti-CMV drug withdrawal, and 4 weeks after treatment discontinuation.
Patients are followed for 12 weeks after treatment cessation.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
CMV-specific T cells
Tidsramme: 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
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from baseline to 4 weeks after end of treatment, an average of 8 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Cumulative incidence of refractory CMV infection
Tidsramme: From Day 1 (first anti-CMV dose) through EOT (inclusive), an average of 4 weeks
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From Day 1 (first anti-CMV dose) through EOT (inclusive), an average of 4 weeks
|
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Cumulative incidence of CMV disease
Tidsramme: From EOT+1 day through 12 weeks after EOT(end of follow-up)
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From EOT+1 day through 12 weeks after EOT(end of follow-up)
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Cumulative incidence of recurrent CMV infection
Tidsramme: From EOT+1 day through 12 weeks after EOT (end of follow-up)
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From EOT+1 day through 12 weeks after EOT (end of follow-up)
|
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Cumulative incidence of acute graft-versus-host disease (aGVHD)
Tidsramme: From Day 1 through 12 weeks after EOT (end of follow-up)
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From Day 1 through 12 weeks after EOT (end of follow-up)
|
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Overall survival
Tidsramme: From Day 1 through 12 weeks after EOT (end of follow-up).
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From Day 1 through 12 weeks after EOT (end of follow-up).
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Cumulative incidence of non-relapse mortality (NRM)
Tidsramme: From Day 1 through 12 weeks after EOT (end of follow-up).
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From Day 1 through 12 weeks after EOT (end of follow-up).
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2026
Primær fullføring (Antatt)
31. mai 2028
Studiet fullført (Antatt)
31. august 2028
Datoer for studieregistrering
Først innsendt
3. juni 2026
Først innsendt som oppfylte QC-kriteriene
3. juli 2026
Først lagt ut (Faktiske)
7. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. juli 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMV-CMI in csCMVi
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data (IPD) for the primary and secondary outcome measures will be made available upon reasonable request to the principal investigator.
Data will be shared after publication of the primary study results, for research purposes only, under a data transfer agreement that ensures compliance with ethical and confidentiality requirements.
Supporting documents (study protocol, statistical analysis plan, and informed consent form) will be available as supplementary files.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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