This is a treatment guideline for an unrelated umbilical cord blood transplant (UCBT) using a myeloablative preparative regimen for the treatment of hematological diseases, including, but not limited to acute leukemias. The myeloablative preparative regimen will consist of cyclophosphamide (CY), fludarabine (FLU) and fractionated total body irradiation (TBI).
This is a study to collect routine clinical data from UCBT using unrelated single or double UCB units as an alternative, non-HLA-matched stem cell source for patients with hematological diseases. * data collection from transplant preparative therapy consisting of treatments with chemotherapeutic regimens and total body irradiation. * data collection from umbilical cord blood selection and infusion. * data collection from standard supportive disease and transplant related care. Pre- and post-transplant medication, UCB selection and infusion, supportive care, and follow-up will be according to the current University of Minnesota BMT guidelines. An average of 18 patients are expected to be treated on this protocol per year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
25 mg/m\^2 IV of Fludarabine will be given over 1 hour on days -8, -7, and -6 pre-UCB transplant.
60 mg/kg IV of Cyclophosphamide will be given over 2 hours on days -7 and -6 pre-UCB transplant.
165 cGy of total body irradiation will be given twice a day on days -4, -3, -2, and -1.
Cyclosporine A (CSA) will start day -3 and will be administered PO/IV maintaining a trough level between 200 and 400 ng/mL. For adults the initial dose will be 2.5 mg/kg IV over 1 hour every 12 hours. For children \< 40 kg the initial dose will be 2.5 mg/kg IV over 1 hour every 8 hours.
Mycophenylate mofetil (MMF) 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (\<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours beginning day -3.
Pre-medications and UCB infusion will be per current institutional policies/guidelines. The infusion of the first UCB unit should begin within 15 minutes, and no later than 30 minutes after arrival on the Unit. If 2 units are used, both cords will be infused within 30-60 minutes of each other as deemed clinically safe by the BMT attending or designee.
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
RECRUITINGSurvival at 1 year post-transplant
The number of patients that are still living 1 year after UCBT.
Time frame: 1 year
Incidence of neutrophil engraftment at day 42.
Number of subjects with neutrophil engraftment at day 42 post UCBT.
Time frame: 42 days
Platelet engraftment at 1 year.
Number of patients with platelet engraftment at 1 year post UCBT.
Time frame: 1 year
Pattern of chimerism after transplant.
Pattern of chimerism after transplant. Chimerism will be plotted with box-plots and described over time.
Time frame: 1 year
Incidence of graft failure.
Cumulative incidence of graft failure after UCBT.
Time frame: 100 days
Incidence of acute graft versus host disease at 100 days.
Cumulative incidence will be used to estimate acute graft versus host disease 100 days after UCBT.
Time frame: 100 days
Incidence of chronic graft versus host disease at 1 year.
Cumulative incidence will be used to estimate chronic GVHD at 1 year post UCBT.
Time frame: 1 year
Incidence of transplant related mortality at 6 months.
Cumulative incidence will be used to estimate transplant related mortality at 6 months post UCBT.
Time frame: 6 months
Incidence of disease free survival
Kaplan-Meier curves will be used to estimate disease-free survival at 1 and 2 years post UCBT.
Time frame: 1, 2 years
Incidence of overall survival.
Kaplan-Meier curves will be used to estimate overall survival at 1 and 2 years post UCBT.
Time frame: 1, 2 years
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