Natural Killer Index From Hematopoietic Stem Cell Graft

NCT00435864 | Completed

• 2 other identifiers: BRD 06/6-NID RCB 2007-A00002-51
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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?

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

allogeneic donor from a file

OTHER

Procedure: Blood test

Registry geno-identical donor family

OTHER

Procedure: Blood test

transplantation of HSCs derived from placental blood

OTHER

Procedure: Blood test

Interventions

Blood test 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; allogeneic donor from a file; transplantation of HSCs derived from placental blood

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• HIV + or HCV + serology during pre-graft analysis
• Patient already treated by an allograft of HSC

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Françoise Mechinaud, md

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Patrice Chevallier, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Nadège Corradini, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Norbert Ifrah, MD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 16, 2007
• Study Start: April 1, 2007
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

FR (1)