Transplantation of Unrelated Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen
- Determine the 1-year survival of patients undergoing unrelated umbilical cord blood
transplantation (UCBT) for hematologic malignancies treated with myeloablative
preparative regimen comprising fludarabine, cyclophosphamide, and fractionated
- Determine the incidence of transplant-related mortality at 6 months after UCBT.
- Evaluate the pattern of chimerism after double UCBT.
- Determine the incidence of neutrophil engraftment at day 42 after UCBT.
- Determine the incidence of platelet engraftment at 6 months after UCBT.
- Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease
(GVHD) at day 100 after UCBT.
- Determine the incidence of chronic GVHD at 1 year after UCBT.
- Determine the disease-free survival at 1 and 2 years after UCBT.
- Determine the incidence of relapse at 1 year after UCBT.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
- Preparative Regimen: Patients receive fludarabine IV over 1 hour on days -8 to -6 and
cyclophosphamide IV on days -7 and -6. Patients also undergo total-body irradiation
twice daily on days -4 to -1.
- Umbilical Cord Blood Transplantation (UCBT): Patients undergo 1 or 2 units of UCBT on
day 0. Patients receive filgrastim (G-CSF) IV once daily beginning on day 1 and
continuing until blood counts recover.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2
hours 2 or 3 times daily beginning on day -3 and continuing until day 100 followed by a
taper until day 180. Patients also receive mycophenolate mofetil IV or orally 2 or 3
times a day beginning on day -3 and continuing until day 30 or 7 days after engraftment
in the absence of acute GVHD.
After completion of study treatment, patients are followed periodically for at least 5
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients alive at 1 year after transplant.
at 1 year
Claudio G. Brunstein, MD, PhD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|