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Natural Killer Index From Hematopoietic Stem Cell Graft

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00435864
Enrollment
92
Registered
2007-02-16
Start date
2007-04-01
Completion date
2013-11-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Chronic Myeloid Leukemia

Keywords

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

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?

Interventions

PROCEDUREBlood 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.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime 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 / recipientJ60 post-HSCT

Secondary

MeasureTime 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 donorJ60 post-HSCT

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFrançoise Mechinaud, md

Nantes University Hospital

PRINCIPAL_INVESTIGATORPatrice Chevallier, MD

Nantes University Hospital

PRINCIPAL_INVESTIGATORNadège Corradini, MD

Nantes University Hospital

PRINCIPAL_INVESTIGATORNorbert Ifrah, MD

University Hospital, Angers

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026