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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02737384 |
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Date of registration:
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08/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Hematopoietic Stem Cells Transplantation in Children With Combined Immunodeficiency (CID)
CD45RA |
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Scientific title:
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Hematopoietic Stem Cells Transplantation in Children With Combined Immunodeficiency (CID): Selective Depletion of Naive Cells From the Graft |
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Date of first enrolment:
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June 14, 2016 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02737384 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Marina CAVAZZANA, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient from 12 months to 18 years
- Combined immunodeficiencies with known molecular diagnosis or if unknown,
corresponding of p-CID study's definition
- Hematopoietic stem cell Transplantation planned with one of the following donors :
- sibling with 1 or 2 HLA antigens mismatch
- parent 10/10 or 9/10 identical
- unrelated donor: 10/10 or 9/10 identical
- Consent form signed by the child's legal guardian
- Patient using effectiveness contraception during this trial
- Affiliated or beneficiary of a health insurance regimen
Exclusion Criteria:
- Wiskott-Aldrich syndrome
- Ongoing pregnancy
- Positive HIV PCR
- Contraindication for hematopoetic stem cell transplantation
- Geno-identical donor in the siblings
- hematopoetic stem cell transplantation antecedent
Age minimum:
12 Months
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Combined Immunodeficiencies
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Intervention(s)
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Biological: Depletion in CD45RA graft donor
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Primary Outcome(s)
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Number of graft rejection
[Time Frame: 12 months after the transplantation]
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Number of graft versus host disease (GVHD) grade III or IV
[Time Frame: 12 months after the transplantation]
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Number of death
[Time Frame: 12 months after the transplantation]
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Secondary Outcome(s)
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Need of antiviral treatment
[Time Frame: 12 months after the transplantation]
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T Lymphocyte proliferations to phytohemagglutinin (PHA)
[Time Frame: 12 months after the transplantation]
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Proportion of T CD4 and CD8 lymphocytes specific of cytomegalovirus, Epstein Barr virus and adenovirus
[Time Frame: 12 months after the transplantation]
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Secondary ID(s)
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2015-A01256-43
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P140317
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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