This single arm pilot phase I study with safety run-in is designed to estimate the safety and efficacy of a familial mismatched or haploidentical hematopoietic stem cell transplantation (haplo-HSCT) using a novel graft modification technique (selective αβ-TCR and CD19 depletion).
≥ 1% for NCI SR ALL
≥ 0.01% for NCI HR ALL
TCF3-HLF t(17;19)
KMT2A rearranged infant ALL, < 6 months of age and presenting WBC of > 300,000 or poor steroid response (peripheral blasts >= 1000 /uL on day 8 of therapy
Available matched related donor. A patient with a matched unrelated donor is eligible if urgent transplantation is required. A prior unrelated donor search is not required for enrollment.
Active non-hematologic malignancy. History of other malignancy is acceptable as long as therapy has been complete and there is no evidence of disease.
Currently receiving any other investigational agents at the time of transplant.
Active CNS or extramedullary disease. History of CNS or extramedullary disease now in remission is acceptable.