Cryopreserved MMUD BM With PTCy for Hematologic Malignancies

Inclusion Criteria

• •Provision of signed and dated informed consent form
• •Stated willingness to comply with all study procedures and availability for the duration of the study
• •Male or female, aged ≥ 18 and \< 71 years (Note: HIV-negative subjects with MDS must be aged \<50 at the time of signing the informed consent form)
• •Diagnosed with
• •Acute leukemias or T-lymphoblastic lymphoma (T-LBL) in 1st or subsequent CR
• •Acute lymphocytic leukemia (ALL) or T-LBL as defined by the following:
• •\< 5% blasts in the bone marrow
• •Normal maturation of all cellular components in the bone marrow
• •No currently active extramedullary disease (EMD) (e.g., central nervous system (CNS), soft tissue disease)
• •ANC ≥ 1,000/mm3
• •Acute myeloid leukemia (AML) defined by the following:
• •\< 5% blasts in the bone marrow
• •No blasts with Auer rods
• •Normal maturation of all cellular components in the bone marrow
• •No currently active EMD (e.g., CNS, soft tissue disease)
• •ANC ≥ 1,000/mm3
• •Acute biphenotypic leukemia (ABL)/Acute undifferentiated leukemia (AUL) defined by the following:
• •\< 5% blasts in the bone marrow
• •Normal maturation of all cellular components in the bone marrow
• •No currently active EMD (e.g., CNS, soft tissue disease)
• •ANC ≥ 1,000/mm3
• •Myleodysplastic Syndromes (MDS), fulfilling the following criteria:
• •Subjects with de novo MDS who have or have previously had Intermediate-2 or High-risk disease as determined by the IPSS. Current Intermediate-2 or High- risk disease is not a requirement
• •Subjects must have \< 20% bone marrow blasts, assessed within 60 days of informed consent
• •Subjects may have received prior therapy for the treatment of MDS prior to enrollment
• •Performance status: Karnofsky ≥ 60%
• •Adequate organ function defined as:
• •Cardiac: LVEF at rest ≥ 35% (RIC cohort) or LVEF at rest ≥ 40% (FIC cohort), or LVFS ≥ 25%
• •Pulmonary: DLCO, FEV1, FVC ≥ 50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected or uncorrected for hemoglobin
• •Hepatic: total bilirubin ≤ 2.5 mg/dL, and ALT, AST, and ALP \< 5 x ULN (unless ALT, AST, and/or ALP are disease related)
• •Renal: SCr within normal range for age (see table 5.1B). If SCr is outside normal range for age, CrCl \> 40 mL/min/1.73m2 must be obtained (measured by 24-hour (hr) urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault formula)
• •Subjects must have the ability to give informed consent according to applicable regulatory and local institutional requirements
• •Availability of deceased HLA MMUD cryopreserved product through Ossium cryobank
• •HLA MMUD defined as 4-7/8 HLA-allele matching at MHC class (A, B, or C) or MHC class II (DRB1)
• •Additional MHC class II HLA (DP and DQ) typing will be collected, but not incorporated in donor selection