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

Inclusion Criteria25

• 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 unable to perform pulmonary function testing
• Karnofsky or Lansky (age dependent) performance score ≥ 50 (See APPENDIX A)
• Bilirubin ≤ 3 times the upper limit of normal for age
• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age
• Donor:
• At least single haplotype matched (≥ 4 of 8) family member
• At least 18 years of age
• HIV negative
• Regarding donation eligibility, is identified as either:
• Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR
• Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271