Natural Killer Index From Hematopoietic Stem Cell Graft

NCT ID: NCT00435864

Last Updated: 2014-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2013-11-30

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?

Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia Acute Myeloblastic Leukemia Chronic Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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allogeneic donor from a file

Group Type OTHER

Blood test

Intervention Type PROCEDURE

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.

Registry geno-identical donor family

Group Type OTHER

Blood test

Intervention Type PROCEDURE

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.

transplantation of HSCs derived from placental blood

Group Type OTHER

Blood test

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Françoise Mechinaud, md

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Patrice Chevallier, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Nadège Corradini, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Norbert Ifrah, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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CHU de Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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ID RCB 2007-A00002-51

Identifier Type: -

Identifier Source: secondary_id

BRD 06/6-N

Identifier Type: -

Identifier Source: org_study_id

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