This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
35 mg/m2 IV/day x 5 days
.8 mg/kg IV Q6h x 8 doses
1.5 mg/kg/day x 3 days
University of Virginia
Charlottesville, Virginia, United States
Event Free Survival
Number of subjects surviving with no events at 180 days post transplantation (Day 0).
Time frame: 180 days
Transplant Engraftment
Number of patients with successful UCB engraftment.
Time frame: Day 42
Incidence of Graft-versus-host disease (GVHD)
Number of patients that experience acute or chronic GVHD.
Time frame: 1 year
Time course for peripheral blood chimerism.
Percent of patients with \>95% donor chimerism.
Time frame: 56 days
Incidence of secondary lymphoproliferative diseases
Number of patients with secondary lymphoproliferative diseases.
Time frame: 6 months
Incidence of disease recurrence
Number of patients experience disease recurrence.
Time frame: Up to two years
Incidence of serious infectious complications
Number of patients experiencing serious infectious complications.
Time frame: 1 year
Overall Survivals
Number of patient with overall event free survival and overall survival distributions.
Time frame: 60 months
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150 cGy for 2 days
Two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient.