High success rate of hematopoietic cell transplantation regardless of donor source in children with very high-risk leukemia.
Wing Leung, Dario Campana, Jie Yang...
https://pubmed.ncbi.nlm.nih.gov/21613256Actively Recruiting
Phase Not Applicable
Age: 0 - 30Years
All Genders
ID04337515
A Feasibility Study Using the CliniMACS Device for Alpha/Beta T-Cell Depletion in Stem Cell Transplant Recipients
Led by Christopher Dvorak · Updated on 2026-04-13
90
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients who need an allogeneic hematopoietic cell transplant (HCT) face the risk of developing graft-versus-host disease (GVHD). To reduce this risk, one approach uses ex vivo alpha-beta T-cell depletion of donor cells. The CliniMACS Device, approved by the FDA for a limited use, can process these cells, but other uses require research protocols. This study explores the feasibility of using the CliniMACS system for alpha-beta T-cell depletion in stem cell transplant recipients to better understand its application beyond approved indications. The CliniMACS CD34 Reagent System uses antibodies linked to magnetic particles to select blood stem cells (CD34+ cells) from donor samples. In this study, stem cell products depleted of alpha-beta T-cells using the CliniMACS system are infused intravenously at a rate based on body weight. The aim is to deliver a target dose of CD34+ cells and minimize alpha-beta T-cell numbers to reduce the risk of GVHD. This approach also includes simultaneous depletion of CD19+ B cells. The study evaluates this method as an alternative to traditional CD34-selection techniques. Participants will receive the alpha-beta T-cell depleted stem cell infusion and be monitored for outcomes including the incidence of severe acute GVHD within 100 days. Other assessments include engraftment success, transplant-related mortality, chronic GVHD requiring steroids, autoimmunity needing immunosuppressive treatment, and T-cell immune recovery over the first year after transplant. Safety and effectiveness of the procedure are followed up to one year, with the total participation duration varying accordingly.
CONDITIONS
Brief Title
A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant
Who Can Participate
Age: 0 - 30Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged 0 to 30 years at time of transplant admission
- Documentation of a disease requiring hematopoietic cell transplant
- A healthy and willing donor available who can donate bone marrow or peripheral blood stem cells
- Matched related donors may be used for patients with Fanconi Anemia
- Written informed consent and ability to comply with study requirements
You will not qualify if you...
- Pregnant, breastfeeding, or unwilling to use birth control during the study
- Presence of any condition or abnormality that may compromise safety or data quality
- Presence of a healthy and willing HLA-identical related donor (except for Fanconi Anemia patients)
- Anticipated life expectancy less than 1 month
- Known hypersensitivity to murine (mouse) proteins or iron dextran
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single treatment period during transplant admission
Participants receive a stem cell product that has been alpha-beta T-cell depleted using the CliniMACS system. The cells are given intravenously over a period based on the volume of the infused product.
1 infusion visit (in-person)
Follow-up
Duration - Up to 12 months after treatment
Participants are monitored for transplant outcomes including acute graft-versus-host disease, engraftment, transplant-related mortality, chronic GVHD, autoimmunity, and immune reconstitution.
Multiple visits over 12 months for monitoring
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
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Research Team
C
Christopher C. Dvorak, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Orly R Klein, Jessica Buddenbaum, Noah Tucker...
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M Ortín, R Raj, E Kinning...
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Christopher C Dvorak, Janel R Long-Boyle, Lucia Holbrook-Brown...
https://pubmed.ncbi.nlm.nih.gov/39042892