Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity Hospital Pilsen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis: AML (exlusion of secondary disease)
Disease status at time of HSCT: complete remission
Karnofsky performance status: ≥80%
Source of HSC: PBSC
Disqualifiers
Prior transplant
Uncontrolled Malignancy
Trial population
Patients who have undergone allogeneic hematopoietic cell transplantation and have been diagnosed with acute myeloid leukemia.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
blood draw
Diagnostic testBlood draw for diagnostic test
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: HSCT patients1 intervention
Trial outcomes
Primary outcomes
1
Detection of peripheral blood iNKTs after HSCT using flow cytometry
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.
Time frame
Day 30, day 60, day 90Secondary outcomes
1
Absolute Number of Circulating iNKT Cells and Their Dynamics After HSCT
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.
Time frame
Day 30, day 60, day 90Other outcomes
1
Correlation of iNKT cell levels with Post-transplant Complications
Correlation of iNKT cell levels with Post-transplant Complications
Time frame
Day 30, day 60, day 90Sponsors and contacts
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Source ClinicalTrials.gov