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.
ALL high risk including one or more of the following: (t(9;22) or 11q23 chromosomal abnormality, primary induction failure (≤15% blasts at time of registration), mixed phenotype acute leukemia (MPAL), persistent MRD (≥0.01% by flow or persistent abnormal karyotype detected by cytogenetics) or hypodiploidy (≤44 chromosomes)) in first remission
ALL in second remission and beyond
History of AML induction/reinduction Failure (≤15% blasts at time of registration)
AML in CR1 with poor cytogenetics (i.e., 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others)
None
Single group
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.
Acute graft versus host disease (aGVHD) incidence
Compare the incidence of grade II to IV aGVHD following allogeneic stem cell trasplantation utilizing α/β CD3+ T-cell and CD19+ B-cell depletion compared to historical controls by day +100
Event-free survival
Evaluate the event-free survival, which is defined as being alive and without evidence of disease relapse
Overall survival
Evaluate the overall survival
Probability of hematopoietic engraftment
Determine the probability of hematopoietic engraftment, as measured by the presence of donor chimerism \>95% by day 100
Cytomegalovirus (CMV) viremia incidence
Determine the incidence of CMV viremia. Viremia is defined as \>1000copies/mL present on at least 2 weekly tests or requiring therapy.
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University of Florida
Lead sponsor
Florida Department of Health
Collaborator
Ocala Royal Dames for Cancer Research
Collaborator
