University of Florida
This is a first in children prospective study of allogeneic hematopoietic cell transplant using a centrally manufactured engineered donor graft (Orca-Q). The study will assess safety and efficacy of Orca-Q in pediatric patients with hematologic malignancies.
Inclusion Criteria (Recipients): * Age \< 22 years of age at the time of diagnosis of malignancy * Eligible for treatment at a pediatric HCT center * Patients with the following histopathologically-confirmed diseases are eligible: 1. Acute myeloid, lymphoid, mixed phenotype or undifferentiated leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) as defined by: * Marrow blasts \< 5% by morphologic examination * Absolute neutrophil count \> 1.0 × 109/L * Platelet count \> 100 × 109/L * Absence of leukemic blasts in the peripheral blood by…
All transplant recipients enrolled on this study in both the phase I and phase II portions will receive Orca-Q (Orca-Q Prime and Orca-Q Supplement) intravenously following myeloablative conditioning.