Haploidentical Donor Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation With a TLI Based Conditioning Regimen in Patients With Hematologic Malignancies

Fecha de inicio: 16 de mayo de 2013

Inclusion Criteria - Transplant Recipients: Age less than or equal to 21 years. Does not have a suitable MSD or volunteer MUD available in the necessary time for stem cell donation. Has a suitable single haplotype matched (≥ 3 of 6) and family member donor. High risk hematologic malignancy. If prior CNS leukemia, it must be treated and in CNS CR Does not have any other active malignancy other than the one for which this HCT is indicated. No prior allogeneic HCT, and no autologous HCT within the previous 12 months. Patient must fulfill pre-transplant evaluation Inclusion Criteria - Haploidentical Donor: At least single haplotype matched (≥ 3 of 6) family member At least 18 years of age. HIV negative. Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female). Not breast feeding. Regarding eligibility, is identified as either: (1) Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR (2) 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.