Natural Killer Index From Hematopoietic Stem Cell Graft

Not Applicable

Completed

• Conditions: Acute Myeloblastic Leukemia; Acute Lymphoblastic Leukemia; Chronic Myeloid Leukemia
• Interventions: Procedure: Blood test

• Registration Number: NCT00435864
• Lead Sponsor: Nantes University Hospital

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-15
• Study First Submitted QC: 2007-02-15
• Study First Posted: 2007-02-16
• Study Start: 2007-04
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-29
• Last Update Posted: 2014-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
allogeneic donor from a file	Blood test	-
Registry geno-identical donor family	Blood test	-
transplantation of HSCs derived from placental blood	Blood test	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France