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

Eligibility Criteria

Sex
ALL
Age
6 Months - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Miltenyi CliniMACS Prodigy ® system — DEVICE
    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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608
Beate Greer
352-294-8744

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