TerminatedPhase 2

Hematopoietic Stem Cells Transplantation in Children With Combined Immunodeficiency (CID)

France4 participantsStarted 2016-06-14

Plain-language summary

The purpose of this study is to evaluate selective depletion of naïve CD45RA+ T cells from allogenic peripheral blood stem cell graft in children transplanted for combined immune deficiency. The aims of this procedure are to prevent graft versus host disease (GVHD) while preserving anti-infectious response from donor memory T lymphocytes.

Who can participate

Age range12 Months – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of death

Timeframe: 12 months after the transplantation

Number of graft rejection

Timeframe: 12 months after the transplantation

Number of graft versus host disease (GVHD) grade III or IV

Timeframe: 12 months after the transplantation

Trial details

NCT IDNCT02737384

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10-26

View on ClinicalTrials.gov More Combined Immunodeficiencies trials