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Natural Killer Index From Hematopoietic Stem Cell Graft

This study is currently recruiting participants.
Verified August 2011 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00435864
First received: February 15, 2007
Last updated: September 1, 2011
Last verified: August 2011
History of Changes
  Purpose

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?


Condition Intervention
Acute Lymphoblastic Leukemia
Acute Myeloblastic Leukemia
Chronic Myeloid Leukemia
 Procedure: Blood test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pilot, Multicenter and Prospective Study of the Natural Killer Index From Hematopoietic Stem Cell Graft at a Genotypic, Phenotypic and Functional Level

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 [ Time Frame: J60 post-HSCT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: J60 post-HSCT ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
allogeneic donor from a file 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.
Registry geno-identical donor family 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.
transplantation of HSCs derived from placental blood 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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435864

Contacts
Contact: Françoise Mechinaud, MD 0240083610 francoise.mechinaud@chu-nantes.fr

Locations
France
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Patrice Chevallier, MD     0240083994     patrice.chevallier@chu-nantes.fr    
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Françoise Mechinaud, md CHU de Nantes
Principal Investigator: Patrice Chevallier, MD CHU de Nantes
Principal Investigator: Nadège Corradini, MD CHU de Nantes
Principal Investigator: Norbert Ifrah, MD University Hospital, Angers
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00435864     History of Changes
Other Study ID Numbers: BRD 06/6-N, ID RCB 2007-A00002-51
Study First Received: February 15, 2007
Last Updated: September 1, 2011
Health Authority: France: Ministry of Health

Keywords provided by Nantes University Hospital:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013