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.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. Acute myeloid, lymphoid, mixed phenotype or undifferentiated leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) as defined by:
✓. Myeloid or lymphoid blast crisis or accelerated phase developing in the setting of chronic myeloid leukemia is an allowed diagnosis provided that patients are in CR or CRi with regard to the blast crisis
✓. Related donor who is a 7 or 8/8 match for HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods
✓. Matched unrelated donor who is a 7 or 8/8 match at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods
✓. Haploidentical related donor who is a ≥ 4/8 but \< 7/8 match at HLA-A, -B, -C, and -DRB1 (typed using DNA-based high-resolution methods), with at most one mismatch per locus
✓. The SARS-CoV-2 testing screening test should be timed such that the results are available prior to the start of the recipient's conditioning regimen. Efforts should be made to minimize the window of time between test result availability and the start of conditioning.
✓. Recipients in screening who test positive for SARS-CoV-2 are ineligible but may be considered eligible for future trial participation provided that they are cleared for transplantation per the most current ASTCT guidelines (https://www.astct.org/connect/astct-response-to-covid-19).
✓. Matched related donor who is a 7 or 8/8 match for HLA-A, -B, -C, and -DRB1, all typed using DNA-based high resolution methods
. a positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or
✕. the presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) \> 1000 by solid phase immunoassay