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 2025-06-15
20
Participants Needed
1
Research Sites
156 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
This study will assess the safety, efficacy, and feasibility of ⍺/β CD3+ T-cell and CD19+ B-cell depletion in allogeneic stem cell transplantation in patients with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), juvenile myelomonocytic leukemia (JMML), high risk myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) and lymphoma. Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.
CONDITIONS
Official 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...
- Children, adolescents, and young adults aged 6 months to 39 years with ALL, AML, JMML, high-risk MDS, CML, or lymphoma
- Specific disease criteria include high-risk ALL in first remission or beyond, AML with induction failure or poor cytogenetics, JMML in remission or recurrence, CML in remission from blast crisis, and lymphoma with induction failure or remission status
- Only one active malignancy allowed at enrollment unless prior/concurrent malignancy does not interfere with study
- Availability of HLA-matched sibling donor, matched unrelated donor, or haplo-identical related donor
- Karnofsky score (for >16 years) or Lansky score (for ≤16 years) of 60% or higher
- Adequate organ function within 4 weeks before starting preparative treatment, including lung, kidney, heart, and liver function
- Written informed consent and agreement to comply with study procedures
- Subjects of childbearing potential must use adequate contraception during and for 8 weeks after treatment
- Partners of subjects of childbearing potential must also use physician-approved contraception during and for 8 weeks after treatment
You will not qualify if you...
- Uncontrolled infection
- Allogeneic stem cell transplantation within the last 6 months unless as a boost
- Active grade 2 or higher acute graft versus host disease
- Demonstrated lack of compliance with medical care
- Unwillingness or inability to use acceptable contraception during and for 8 weeks after treatment for subjects of childbearing potential
- Known pregnancy or breastfeeding
- Any medical condition that contraindicates protocol therapy or increases risk for complications as judged by the physician
- Being a prisoner, incarcerated, or compulsorily detained for psychiatric or physical illness
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
B
Beate Greer
CONTACT
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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