Status:
RECRUITING
A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant
Lead Sponsor:
Christopher Dvorak
Conditions:
Graft Vs Host Disease
Graft-versus-host-disease
Eligibility:
All Genders
Up to 30 years
Phase:
NA
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 r...
Detailed Description
The original CliniMACS® device (CD34 Reagent System) employs a reagent consisting of an antibody that specifically binds to blood cells that express the CD34+ surface marker (hematopoietic stem cells ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2035
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04337515
Start Date
December 19 2019
End Date
January 1 2035
Last Update
March 30 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143