A Cyclophosphamide/Fludarabine/Total Body Irradiation Preparative Regimen for Patients With Hematological Malignancy Receiving Unrelated Donor Umbilical Cord Blood Transplantation
- Determine the engraftment potential of unrelated allogeneic umbilical cord blood (UCB)
using nonmyeloablative conditioning comprising fludarabine, cyclophosphamide, and
total-body irradiation followed by post-transplant immunosuppression comprising
cyclosporine and mycophenolate mofetil in patients with hematologic malignancies.
- Determine the rate of neutrophil and platelet recovery and the completeness of donor
cell engraftment in patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease
(GVHD) in patients treated with this regimen.
- Determine the incidence of malignant relapse in patients treated with this regimen.
- Determine the 1- and 2-year survival and event-free survival of patients treated with
- Determine the phenotype and function of immune cells recovering after UCB
transplantation in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to HLA disparity (0-1 vs 2) and number of graft
units (1 vs 2).
- Nonmyeloablative conditioning: Patients receive nonmyeloablative conditioning
comprising fludarabine IV over 1 hour on days -8 to -6 and cyclophosphamide IV over 2
hours on days -7 and -6. Patients undergo total-body irradiation twice daily on days -4
- Unrelated allogeneic umbilical cord blood transplantation (UCBT): Patients undergo 1 or
2 unrelated allogeneic UCBTs on day 0.
- Immunosuppression: Patients receive cyclosporine orally or IV over 2 hours 2-3 times
daily beginning on day -3 and continuing until day 100, followed by a taper in the
absence of graft-vs-host disease (GVHD). Patients also receive mycophenolate mofetil
orally or IV twice daily on days -3 to 30, continuing beyond day 30 if no donor
engraftment. Patients also receive filgrastim (G-CSF) IV or subcutaneously beginning on
day 1 and continuing until blood counts recover.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Engraftment as measured by an absolute neutrophil count of donor origin > 0.5 x 109 /L for 3 days by day 42
Claudio G. Brunstein, MD, PhD
Masonic Cancer Center, University of Minnesota
United States: Federal Government
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|