Natural Killer Index From Hematopoietic Stem Cell Graft

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00435864

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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?

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia Acute Myeloblastic Leukemia Chronic Myeloid Leukemia	Procedure: Blood test	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: allogeneic donor from a file	Procedure: Blood test 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.
Other: Registry geno-identical donor family	Procedure: Blood test 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.
Other: transplantation of HSCs derived from placental blood	Procedure: Blood test 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.

Arm

Intervention/Treatment

Other: allogeneic donor from a file

Procedure: Blood test

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.

Other: Registry geno-identical donor family

Procedure: Blood test

Other: transplantation of HSCs derived from placental blood

Procedure: Blood test

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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