Status:
COMPLETED
Immunoregulatory T Lymphocytes Subtypes and Haematopoietic Stem Cell Transplantation (HSCT)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies
Eligibility:
All Genders
Brief Summary
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 alg...
Detailed Description
Allogeneic hematopoietic stem cell transplantation (HSCT) remains the only curative treatment in most haematological malignancies. However, its anti-tumor effect (GVT) is often associated with the dev...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
February 2 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 18 2022
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT02194868
Start Date
February 2 2016
End Date
January 18 2022
Last Update
November 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Necker
Paris, France, 75015