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Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation (QiNKT-HSCT)

29. april 2026 opdateret af: University Hospital Pilsen

Standardised Quantification of Invariant NKT Cells Using DryTube Technology and Flow Cytometry in Patients Who Have Undergone Allogeneic Haematopoietic Stem Cell Transplantation.

The transplantation of allogeneic haematopoietic stem cells (HSCs) can lead to serious complications after transplantation, such as graft-versus-host disease (GvHD), infections and relapse due to immunosuppression. Invariant NKT cells (iNKT cells) play a pivotal role in modulating the immune response and have been demonstrated to be instrumental in the pathogenesis of GvHD, cytomegalovirus (CMV) infection, and relapse. Their levels are associated with the development of these complications. This multicentre study aims to test the feasibility of standardising iNKT cell monitoring and to investigate the association between iNKT cell levels and post-transplant complications.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

75

Kontakter og lokationer

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Studiekontakt

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Studiesteder

    • Czechia
      • Pilsen, Czechia, Tjekkiet, 32300
        • University Hospital Pilsen
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Michal Karas, MD, Ph.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients who have undergone allogeneic hematopoietic cell transplantation and have been diagnosed with acute myeloid leukemia.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
HSCT patients
Patients who have undergone allogeneic hematopoietic cell transplantation and have been diagnosed with acute myeloid leukemia.
Blood draw for diagnostic test

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. januar 2029

Datoer for studieregistrering

Først indsendt

16. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

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Kliniske forsøg med Akut myeloid leukæmi

Kliniske forsøg med blood draw

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