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This is a pilot study designed to evaluate the safety and feasibility of performing umbilical cord blood transplants in adults with high-risk hematopoietic malignancies. A novel myeloablative preparative regimen will be used. One, up to a maximum of three cord blood units will be administered to facilitate engraftment.
Full description
This study intends to demonstrate an engraftment rate of >80% at day 100 post-transplantation and a transplant related mortality rate of < or equal to 50%. A TRM of >50% will be considered unacceptable. The present research will also:
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Inclusion criteria
Age < or equal to 55
Availability of donor cord blood (one to three units) matching at least 4 of 6 HLA antigens (A, B, and DR). HLA class I antigens will be determined by serologic methods, and Class II antigens will be determined by high-resolution DNA typing. Typing will be confirmed by UCSF Immunogenetics Department following infusion. The UCB units must contain >2.5 x 10(7) TNC per kilogram recipient body weight. Cord blood units will be obtained from all available international banks.
HLA identical or 1 antigen mismatched related donors or potential HLA-matched unrelated donors (MUD) matching at >6/8 (A, B,C, DR) alleles must NOT be available.
Disease types:
Patients must have an ECOG PS< or equal to 2
Laboratory requirements:
Creatinine <2.0mg/dL and creatinine clearance >40/m/min (calculated or based on 24 hour urine collection)
Bilirubin <2.0 mg/dL, AST/alkaline phosphatase <3x upper limit of normal
Patients with hepatitis C and active Hepatitis B are eligible only if a liver biopsy is performed and there is a < or equal to grade 2 inflammation or fibrosis.
Cardiac ejection fraction >40%
DLCO >40%
Negative pregnancy test (females of reproductive age)
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Data sourced from clinicaltrials.gov
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