- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00435864
Natural Killer Index From Hematopoietic Stem Cell Graft
April 29, 2014 updated by: Nantes University Hospital
Pilot, Multicenter and Prospective Study of the Natural Killer Index From Hematopoietic Stem Cell Graft at a Genotypic, Phenotypic and Functional Level
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?
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nantes, France, 44093
- CHU de Nantes
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: allogeneic donor from a file
|
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.
|
Other: Registry geno-identical donor family
|
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.
|
Other: transplantation of HSCs derived from placental blood
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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J60 post-HSCT
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
J60 post-HSCT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
February 15, 2007
First Submitted That Met QC Criteria
February 15, 2007
First Posted (Estimate)
February 16, 2007
Study Record Updates
Last Update Posted (Estimate)
April 30, 2014
Last Update Submitted That Met QC Criteria
April 29, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Leukemia, Lymphoid
- Leukemia, Myeloid
- Leukemia
- Leukemia, Myeloid, Acute
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Other Study ID Numbers
- BRD 06/6-N
- ID RCB 2007-A00002-51
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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