Trial of AB-110 in Adults With Hematologic Malignancies Undergoing Cord Blood Transplantation

Inclusion Criteria

• •Patients must have received some immunosuppressive chemotherapy in the preceding 3 months.
• •Acute myelogenous leukemia (AML):
• •1. Complete first remission (CR1) at high risk for relapse
• •2. Complete second remission (CR2).
• •3. No documented myelofibrosis at screening marrow biopsy
• •Acute lymphoblastic leukemia (ALL):
• •1. Complete first remission (CR1) at high risk for relapse
• •2. Complete second remission (CR2).
• •Other acute leukemias that are of ambiguous lineage or of other types
• •Any acute leukemia with marrow aplasia or without adequate count recovery.
• •Myelodysplastic Syndrome (MDS)
• •Karnofsky score \> 70 %.
• •Calculated creatinine clearance \> 60 ml/min.
• •Bilirubin \< 1.5 mg/dL, ALT \< 3 x upper limit of normal
• •Pulmonary function (FVC, FEV1 and corrected DLCO) \> 50% predicted.
• •Left ventricular ejection fraction \> 50%.
• •Albumin \> 3.0 g/dL.
• •Negative antiviral serology:
• •Negative human immunodeficiency virus (HIV) antibody.
• •Negative human T-lymphotropic virus (HTLV)-1 and 2 antibodies.
• •Negative hepatitis B surface antigen (HBsAg) and undetectable hepatitis B virus (HBV) DNA
• •Negative hepatitis C virus (HCV) antibody or negative HCV ribonucleic acid (RNA)
• •For female subjects of childbearing potential:
• •1. A negative serum pregnancy test
• •2. Willing to use contraception throughout the study period.
• •Male subjects must be willing to use a recommended method of contraception throughout the study period, and to refrain from sperm donation throughout the study period.
• •Two appropriate CB units identified for the subject.
• •In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.
• •Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
• •Evidence of a signed informed written consent