NCT04337515 A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant
| NCT ID | NCT04337515 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Christopher Dvorak |
| Condition | Graft Vs Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2019-12-19 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2019-12-19 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Christopher C Dvorak, MD
PRINCIPAL INVESTIGATOR
Professor of Clinical Pediatrics
Frequently Asked Questions
Who can join the NCT04337515 clinical trial?
This trial is open to participants of all sexes, up to 30 Years, studying Graft Vs Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04337515 currently recruiting?
Yes, NCT04337515 is actively recruiting participants. Contact the research team at christopher.dvorak@ucsf.edu for enrollment information.
Where is the NCT04337515 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT04337515 clinical trial?
NCT04337515 is sponsored by Christopher Dvorak. The principal investigator is Christopher C Dvorak, MD at Professor of Clinical Pediatrics. The trial plans to enroll 90 participants.