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 range

12 Months – 18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Plain-language summary

Who can participate

Age range

12 Months – 18 Years

Sex

ALL

See this in plain English?

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