Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation

NCT07570407 | Not Yet Recruiting

• 1 other identifier: QiNKT-HSCT
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Allogeneic HSCT; Posttransplant Complications; GvHD; Relapse; Acute Myeloid Leukemia

Keywords

iNKT cells; HSCT; Flow cytometry; Reconsitution

Outcome Measures

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.

  Day 30, day 60, day 90

Secondary Outcomes (1)

• Absolute Number of Circulating iNKT Cells and Their Dynamics After HSCT

  Day 30, day 60, day 90

Other Outcomes (1)

• Correlation of iNKT cell levels with Post-transplant Complications

  Day 30, day 60, day 90

Study Arms (1)

HSCT patients

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

Diagnostic Test: blood draw

Interventions

blood draw DIAGNOSTIC_TEST

Blood draw for diagnostic test

HSCT patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Diagnosis: AML (exlusion of secondary disease)
• Disease status at time of HSCT: complete remission
• Karnofsky performance status: ≥80%
• Source of HSC: PBSC

You may not qualify if:

• Prior transplant
• Uncontrolled Malignancy

Sponsors & Collaborators

• University Hospital Pilsen: lead

Study Sites (1)

University Hospital Pilsen

Pilsen, Czechia, 32300, Czechia

Location

MeSH Terms

Conditions

Recurrence; Leukemia, Myeloid, Acute

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Monika Holubová, MD, Ph.D.

CONTACT

+420 377 103 991; holubovam@fnplzen.cz

Lenka Lukášová, MD, Ph.D.

CONTACT

+420 377 103 871; LUKASOVALE@fnplzen.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CZ (1)