- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07570407
Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation (QiNKT-HSCT)
Standardised Quantification of Invariant NKT Cells Using DryTube Technology and Flow Cytometry in Patients Who Have Undergone Allogeneic Haematopoietic Stem Cell Transplantation.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Allogeneic haematopoietic stem cell transplantation (HSCT) is a treatment for many serious haematological malignancies. Despite advances in pre- and post-transplant management, a significant proportion of patients still develop adverse effects such as graft-versus-host disease (GvHD), relapse or cytomegalovirus reactivation. These reactions can significantly reduce patients' quality of life and may even be fatal. Invariant NKT cells (hereafter referred to as iNKT cells) are a rare population of T lymphocytes that play an important role in regulating the immune response. Depending on the expression of CD4 and CD8 markers, they can be divided into several subpopulations. iNKT cells can simultaneously support both Th1 and Th2 immune responses while suppressing the inflammatory response. Therefore, they appear to be suitable for treating diseases involving deregulated immunity, such as GvHD, autoimmune diseases, and oncological diseases. The concentration of iNKT cells after HSCT is highly variable. According to the available data, iNKT cell kinetics correspond to the severity of GvHD, as well as the risk of relapse and the development of infectious complications. However, these data are usually obtained using locally set protocols and come from single-centre measurements, which reduces their validity and clinical utility as both a biomarker and background data for possible allogeneic applications of iNKT cells in patients with low levels. To eliminate bias caused by specific local data processing and provide a robust dataset, a multicentre study is necessary to yield a representative set of results, as this is the only way to definitively establish the impact of iNKT cell levels on post-transplant outcomes. Flow cytometric analysis enables the combined examination of specific markers on the surface of cells and inside them. Due to the increasing complexity and heterogeneity of protocols, antibody manufacturers often resort to standardised dried panels, which ensure high consistency of measured data.
This project will involve monitoring iNKT cells at defined time points following allogeneic transplantation. The project's outcomes will be to determine the feasibility of standardising iNKT monitoring using the DryTube flow cytometry assay, establish differences in iNKT levels in transplanted patients across different centres, and estimate the association between iNKT levels and post-transplant complications.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Monika Holubová, MSc.
- Telefonnummer: +420 377 103 991
- E-post: holubovam@fnplzen.cz
Studer Kontakt Backup
- Navn: Lenka Lukášová, MD, MSc.
- Telefonnummer: +420 377 103 871
- E-post: LUKASOVALE@fnplzen.cz
Studiesteder
-
-
Czechia
-
Pilsen, Czechia, Tsjekkia, 32300
- Rekruttering
- University Hospital Pilsen
-
Ta kontakt med:
- Monika Holubová, MSc.
- Telefonnummer: +420 377 103 991
- E-post: holubovam@fnplzen.cz
-
Ta kontakt med:
- Lenka Lukášová, MD, MSc.
- Telefonnummer: +420 377 103 871
- E-post: LUKASOVALE@fnplzen.cz
-
Hovedetterforsker:
- Michal Karas, MD, MSc.
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Diagnosis: AML (exlusion of secondary disease)
- Disease status at time of HSCT: complete remission
- Karnofsky performance status: ≥80%
- Source of HSC: PBSC
Exclusion Criteria:
- Prior transplant
- Uncontrolled Malignancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
HSCT patients
Patients who have undergone allogeneic hematopoietic cell transplantation and have been diagnosed with acute myeloid leukemia.
|
Blood draw for diagnostic test
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Detection of peripheral blood iNKTs after HSCT using flow cytometry
Tidsramme: Day 30, day 60, day 90
|
iNKTs will be monitored in peripheral blood using a mixture of dried antibodies and bulk lysis and flow cytometry.
This mixture of antibodies contains the specific iNKT marker (TCRVα24Jα18) and markers for the main subsets.
The percentage of iNKT cells among leukocytes and T cells, as well as the proportion of CD4 and CD8 iNKT subsets, will be provided.
|
Day 30, day 60, day 90
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Absolute Number of Circulating iNKT Cells and Their Dynamics After HSCT
Tidsramme: Day 30, day 60, day 90
|
Leukocyte count will be estimated through hematological analysis, and circulating iNKTs will be counted based on flow cytometry percentage in Patient´s Peripheral Blood At day + 30, +60, +90 After HSCT.
The level of iNKTs will be reported as the number of cells per milliliter of peripheral blood.
|
Day 30, day 60, day 90
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation of iNKT cell levels with Post-transplant Complications
Tidsramme: Day 30, day 60, day 90
|
Correlation of iNKT cell levels with Post-transplant Complications
|
Day 30, day 60, day 90
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer
- Sykdomsattributter
- Neoplasmer etter histologisk type
- Hematologiske sykdommer
- Leukemi, myeloid
- Leukemi
- Patologiske tilstander, tegn og symptomer
- Hemic og lymfatiske sykdommer
- Tilbakefall
- Leukemi, Myeloid, Akutt
- Undersøkelsesteknikker
- Prøvehåndtering
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Punkteringer
- Kirurgiske prosedyrer, operativ
- Blodprøveinnsamling
Andre studie-ID-numre
- QiNKT-HSCT
Plan for individuelle deltakerdata (IPD)
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