Back to resultsNatural Killer Index From Hematopoietic Stem Cell Graft
Primary Purpose
Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Chronic Myeloid Leukemia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test
Sponsored by
About this trial
This is an interventional health services research trial for Acute Lymphoblastic Leukemia focused on measuring 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
Eligibility 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
Sites / Locations
- CHU de Nantes
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
allogeneic donor from a file
Registry geno-identical donor family
transplantation of HSCs derived from placental blood
Arm Description
Outcomes
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
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
Full Information
NCT ID
NCT00435864
First Posted
February 15, 2007
Last Updated
April 29, 2014
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00435864
Brief Title
Natural Killer Index From Hematopoietic Stem Cell Graft
Official Title
Pilot, Multicenter and Prospective Study of the Natural Killer Index From Hematopoietic Stem Cell Graft at a Genotypic, Phenotypic and Functional Level
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
allogeneic donor from a file
Arm Type
Other
Arm Title
Registry geno-identical donor family
Arm Type
Other
Arm Title
transplantation of HSCs derived from placental blood
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Blood test
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françoise Mechinaud, md
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrice Chevallier, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nadège Corradini, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norbert Ifrah, MD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
12. IPD Sharing Statement
Learn more about this trial
Natural Killer Index From Hematopoietic Stem Cell Graft
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