TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies
Trial Parameters
Brief Summary
This is a phase I, prospective clinical trial studying the safety and feasibility of providing early memory T-cell DLI. The primary objective is: \- To assess the safety and feasibility of early CD45RA-depleted DLI administration. The secondary objectives are * To assess the safety and feasibility of the addition of blinatumomab in the early post-transplant period in patients with CD19+ malignancy. * To measure and describe the pharmacokinetics of rabbit ATG in HCT recipients on this study.
Eligibility Criteria
Inclusion Criteria: Recipient: * Age less than or equal to 21 years * High risk hematologic malignancy whereas allogeneic transplantation is the current standard of care. This includes (but is not limited to): * High risk ALL in CR1 or CR2, * any ALL in CR3 or subsequent; * AML in high risk CR1 (AML diagnosis includes myeloid sarcoma), * any AML in CR2 or subsequent, * any therapy related AML; * MDS (primary or secondary), * NK cell, biphenotypic, or undifferentiated leukemia/lymphoma in CR1 or subsequent; * CML in accelerated phase, or in chronic phase with persistent molecular positivity or intolerance to tyrosine kinase inhibitor, or a history of blast crisis. * If prior CNS leukemia, it must be treated and in CNS CR * Left ventricular ejection fraction \> 40%, or shortening fraction ≥ 25% * Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2 * Forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unabl