- Lack of suitable conventional donor (i.e. 7/8 or 8/8 related or 7/8 or 8/8 unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
- HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, and DRBl, and loci. A minimum match of 5/10 is required. The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1.
- Subjects with adequate physical function as measured by:a)Cardiac: Left ventricular ejection fraction at rest must be >35%, or shortening fraction > 25%. b)Hepatic: Bilirubin < 2.5 mg/dL; and ALT, AST, and Alkaline Phosphatase < 5 x ULN. c)Renal: Serum creatinine within normal range for age, or creatinine clearance or GFR > 40 mL/min/1.73m2. d)Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin); or 02 saturation > 92% on room air.
- Clinical Diagnosis of one of the following: Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Lymphoma
- Subjects must have received cytotoxic chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
- Performance status: Karnofsky/Lansky score > 60%.
Other eligibility criteria may apply.
- HLA-matched, related or 7-or 8/8 allele matched (HLA-A,-B,-Cw,-DRBl) unrelated donor able to donate.
- Autologous hematopoietic stem cell transplant < 3 months prior to enrollment.
- Pregnancy or breast-feeding.
- Evidence of HIV infection or known HIV positive serology.
- Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
- Non-hematologic malignancy within prior three (3) years.
- Prior allogeneic hematopoietic stem cell transplant.
- Subjects with a history of primary idiopathic myelofibrosis.
- Bovine product allergy.
Other exclusion criteria may apply.