Natural Killer Index From Hematopoietic Stem Cell Graft

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435864
• Other study ID #: BRD 06/6-N
• Secondary ID: ID RCB 2007-A000
• Status: Completed
• Phase: N/A
• First received: February 15, 2007
• Last updated: April 29, 2014
• Start date: April 2007
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloblastic Leukemia
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No