Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
LymphomaMyelomaLeukemiaMyelodysplasiaSolid TumorsHodgkin's DiseaseMyelofibrosis
Interventions
PROCEDURE

Total Body Irradiation with Fludarabine in UCB Transplants

Administration of the preparative regimen, infusion of the stem cell graft, inpatient care during the immediate post-transplant period and outpatient follow-up for the first 3 months after transplant and at 6, 12, 24 and 36 months. Patients will have human leukocyte antigen (HLA) serologic typing and DNA typing. Bags of UCB are thawed, and diluted by 1:1 volume using a 5% albumin/dextran solution. The thawed and diluted umbilical cord blood unit (UCBU) is next weighed and centrifuged. Specimens are obtained for cell count and viability, culture, clonogenic assays, and phenotype. The UCB is infused at a rate of 1-3 ml/min. Furosemide (0.5-1.0 mg/kg/dose) may be given if volume overload or decreased urine output occurs. Each UCB infusion shall be tested for sterility, CFU content, number of CD34+ cells, cell count and viability.

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER

NCT00606437 - Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants | Biotech Hunter | Biotech Hunter