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A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant

RecruitingNAAges any - 30 YearsAllChristopher Dvorak
NCT04337515 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female 0-30 years of age at time of transplant admission * Documentation of a disease requiring HCT * A donor (mismatched related or unrelated) must be located who are healthy and willing, and whom are able to donate bone marrow (BM) or peripheral blood stem cells (PBSC). Matched related donors may be used for patients with Fanconi Anemia. * Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Exclusion Criteria: * Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data * Presence of a healthy and willing HLA-identical related donor (except when the patient has Fanconi Anemia). * Patient with an anticipated life expectancy of \<1 month * Patients with known hypersensitivity to murine (mouse) proteins or iron dextran
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What it tests

  • CliniMacs®
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Where

1 site
University of California, San Francisco
San Francisco, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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