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About
A phase 1b, open label, multi-center trial of AB-110 in adults with hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplasia (MDS) undergoing cord blood transplantation. Subjects will receive unmanipulated cord blood (UCB) and AB-110 expanded CD34 enriched hematopoietic progenitor cells (HSPC).
Enrollment
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Inclusion criteria
Patients must have received some immunosuppressive chemotherapy in the preceding 3 months.
Acute myelogenous leukemia (AML):
Acute lymphoblastic leukemia (ALL):
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:
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
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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