Clinical trial · Observational
Immunoregulatory T Lymphocytes Subtypes and Haematopoietic Stem Cell Transplantation (HSCT)
Role and Interactions Between Immunoregulatory T Lymphocytes Subtypes After Allogeneic Haematopoietic Stem Cell Transplantation (HSCT): Identification of New Partners Implicated on the Development of GVT (Graft Versus Tumor) and Anti-infectious Responses Without GVHD (Graft Versus Host Disease)
- 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 purpose of this study is to confirm that invariant NKT lymphocytes (iNKT) reconstitution in recipient and in the graft content can predict the outcome of human allogeneic HSCT and to set up an algorithm for clinical practice that would allow the prediction of acute GVHD risk according to the quantity and functionality
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donors | Biological | — | UNRESOLVED |
| Recipients | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- donors of hematopoietic stem
- description
- Adult and minor donors of hematopoietic stem
- label
- patients requiring allogeneic hema
- description
- Adult and minor patients (recipients) requiring allogeneic hema
- interventionNames
- Biological: Recipients
Primary outcomes (1)
- measure
- Occurrence of aGVHD
- timeFrame
- until 3 years post graft
- description
- Patients' clinical files
Secondary outcomes (1)
- measure
- iNKT and effectors of the immune allogeneic response
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Criteria for adults: * Allogeneic HSCT with peripheral blood stem cell (PBSC) graft * Patients transplanted in cytologic Complete Remission (CR) * HLA 10/10 on HLA A, B, Cw, DRB1 and DQ molecules, from an intrafamilial or an unrelated donor * \- Fludarabine-ivBusulfan-ATG based reduced intensity/toxicity conditioning. Iv Busulfan doses between 6.4 mg/kg to 9.6 mg/kg or Fludarabine - TBI ≤ 8 Gy are accepted. ATG should be thymoglobuline at 5 mg/kg * Consent form signed by the patient * Consent form signed by the donor * Affiliated or beneficiary of a health insurance regimen 2. Criteria for pediatric patients: * Allogeneic HSCT with bone marrow grafts * Myeloablative conditioning (either TBI 12 Gy with Cyclophosphamide or iv Busulfan (12.8 mg/kg) and cyclophosphamide or Fludarabine - TBI \> 8 Gy)- HLA 10/10 on HLA A, B, Cw, DRB1 and DQ molecules, from an intrafamilial or an unrelated donor * Consent form signed by the parents * Consent form signed by the donor or his legal representative if it is minor * Beneficiary of a health insurance regimen Exclusion Criteria: * History of previous autologous or allogeneic haematopoietic stem cell transplantation * Disease non in cytologic CR at transplant * Other type of conditioning than Fludarabine-ivBusulfan-ATG based reduced intensity/toxicity. * Donor graft with any HLA mismatch including haploidentical and cord blood grafts * Graft having one or more mismatch with the recipient HLA
References
Publications (0)
Data not yet available