Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- University of Florida
- Study ID
- NCT05800210
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Chronic Myeloid Leukemia
- Juvenile Myelomonocytic Leukemia
- Lymphoma, Hodgkin
- Lymphoma, Non-Hodgkin
- Myelodysplastic Syndromes
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Months - 39 Years
- Healthy Volunteers
- Not accepted
Interventions
- Miltenyi CliniMACS Prodigy ® system — DEVICESubjects 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.
Study Details
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.
Key Dates
- Start date
- May 3, 2024
- Status verified
- Jun 2026
- Primary completion
- May 31, 2027
- Completion
- May 31, 2028
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Allogeneic stem cell transplant with ⍺/β CD3+ T-cell and CD19+ B-cell depleted graft
Primary Outcome Measure
Acute graft versus host disease (aGVHD) incidence [ Time Frame: 100 days ]
Central Contacts
- Beate Greer352-294-8744
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 |
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