Actively Recruiting
Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases
Led by University of Florida · Updated on 2026-06-04
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
F
Florida Department of Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and practical use of removing alpha/beta CD3+ T-cells and CD19+ B-cells in stem cell transplants for patients with several blood cancers, including acute lymphocytic leukemia, acute myeloid leukemia, juvenile myelomonocytic leukemia, high-risk myelodysplastic syndrome, chronic myeloid leukemia, and lymphoma. This Phase 2 study focuses on patients aged 6 months to 39 years undergoing allogeneic stem cell transplantation. Participants receive stem cell transplants processed with the Miltenyi CliniMACS Prodigy® system, which depletes alpha/beta CD3+ T-cells and CD19+ B-cells from the donor graft. This specialized transplant is studied to assess its impact on transplant outcomes and complications. Throughout the study, researchers will monitor participants for the occurrence of acute graft versus host disease within 100 days after transplant. Additional outcomes include survival rates over two years, success of stem cell engraftment, and the incidence of viral infections and post-transplant lymphoproliferative disorder over the first year. Participants will be followed closely with clinical assessments and laboratory tests to track these outcomes until at least two years post-transplant.
CONDITIONS
Brief Title
Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 6 months to 39 years
- Diagnosed with ALL, AML, JMML, high-risk MDS, CML, or Hodgkin/Non-Hodgkin lymphoma
- Specific disease stages or risk factors as defined for each condition
- No more than one active malignancy at enrollment
- Availability of HLA-matched sibling donor, matched unrelated donor, or haplo-identical related donor
- Karnofsky or Lansky performance score of 60% or higher
- Adequate lung, kidney, heart, and liver function within 4 weeks before treatment
- Written informed consent obtained
- Use of effective contraception during study and 8 weeks after last treatment dose for participants of childbearing potential and their partners
You will not qualify if you...
- Documented uncontrolled infection
- Allogeneic stem cell transplantation within the past 6 months (unless as a boost)
- Active grade 2 or higher acute graft versus host disease
- Failure to comply with medical care
- Unwillingness or inability to use contraception during study and 8 weeks after last treatment dose
- Pregnancy or breastfeeding
- Any other disease or condition that increases risk with study treatment or affects results
- Prisoners or individuals incarcerated or detained for psychiatric or physical illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-transplant period
Participants receive an allogeneic stem cell transplant with grafts depleted of alpha/beta CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.
1 transplant visit and multiple follow-up visits during hospital stay
Duration - Up to 1 year
Participants are monitored for transplant outcomes, including graft versus host disease and viral infections, up to 1 year after transplantation.
Regular visits during the first 100 days and periodic visits up to 1 year
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
B
Beate Greer
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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