Natural Killer Index From Hematopoietic Stem Cell Graft

Study Overview
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Brief Summary
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Numerous studies about the potential role of NK alloreactive during a n hematopoietic stem cells graft are based on genotypical analyses of the KIR receptors and on genotypic incompatibilities between KIR and HLA for couple donor/recipient. There is still a lot of issues non resolved: Are KIR really expressed and how occur their expression during time when hematopoietic reconstitution? Is it depending on HLA of the recipient?If KIR are expressed, what are the mechanisms of alloreactivity of NK cells? Are NK able to lyse tumoral cells? Could alloreactive NK cells constitute a therapeutic tool able to induce tolerance and elimination of leukemia during hematopoietic stem cells grafts?

Official Title
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Pilot, Multicenter and Prospective Study of the Natural Killer Index From Hematopoietic Stem Cell Graft at a Genotypic, Phenotypic and Functional Level

Conditions
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Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Chronic Myeloid Leukemia

Intervention / Treatment
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* Procedure: Blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age superior to 1 year Patient that will be treated by an HSC graft Initial pathology of recipient: acute lymphoblastic leukemia, acute myeloblastic leukemia, chronic myeloid leukemia Exclusion Criteria: Patient already included in a study with an exclusion period HIV + or HCV + serology during pre-graft analysis Patient already treated by an allograft of HSC

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: allogeneic donor from a file<br> | Procedure: Blood test<br>* The study of KIR and HLA genes will be performed on samples of cord blood or peripheral blood donor and recipient before transplant For grafts from placental cord blood, we do ask any additional samples.<br>|
| Other: Registry geno-identical donor family<br> | Procedure: Blood test<br>* The study of KIR and HLA genes will be performed on samples of cord blood or peripheral blood donor and recipient before transplant For grafts from placental cord blood, we do ask any additional samples.<br>|
| Other: transplantation of HSCs derived from placental blood<br> | Procedure: Blood test<br>* The study of KIR and HLA genes will be performed on samples of cord blood or peripheral blood donor and recipient before transplant For grafts from placental cord blood, we do ask any additional samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate in the pilot study the percentage of different NK cell populations during hematopoietic reconstitution after HSCT with regard to the KIR and HLA genotypes of donor / recipient |  | J60 post-HSCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic analysis of KIR and HLA incompatibility of donor and recipient - Rate of in vitro amplification of NK cells from the donor - Assess the percentage of NK cells from the donor |  | J60 post-HSCT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recipient of a HSC graft in Acute Myeloblastic Leukemia therapy, recipient of a HSC graft in others pathologies treated in hematology of Nantes university hospital or Angers university hospital, donors are healthy subjects