Clinical trial · Observational
Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation
Standardised Quantification of Invariant NKT Cells Using DryTube Technology and Flow Cytometry in Patients Who Have Undergone Allogeneic Haematopoietic Stem Cell Transplantation.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Allogeneic HSCT | — | UNRESOLVED | — |
| GvHD | — | UNRESOLVED | — |
| Posttransplant Complications | — | UNRESOLVED | — |
| Relapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood draw | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HSCT patients
- description
- Patients who have undergone allogeneic hematopoietic cell transplantation and have been diagnosed with acute myeloid leukemia.
- interventionNames
- Diagnostic Test: blood draw
Primary outcomes (1)
- measure
- Detection of peripheral blood iNKTs after HSCT using flow cytometry
- timeFrame
- Day 30, day 60, day 90
- description
- 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.
Secondary outcomes (1)
- measure
- Absolute Number of Circulating iNKT Cells and Their Dynamics After HSCT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available