Non-Myeloablative Conditioning and Unrelated Umbilical Cord Blood Transplantation for Children and Adults With Serious Oncohematologic Diseases
- Determine the frequency, extent, and rate of donor (myeloid and lymphoid) engraftment
in patients with serious hematologic malignancies treated with nonmyeloablative
conditioning regimen comprising fludarabine, cyclophosphamide, and low-dose total-body
irradiation followed by unrelated allogeneic umbilical cord blood transplantation and
post-transplant immunosuppression comprising cyclosporine and mycophenolate mofetil.
- Correlate clinical and umbilical cord blood-related factors with engraftment in
patients treated with this regimen.
- Determine transplant-related complications, in terms of toxicity, myelosuppression,
infections, and acute and chronic graft-versus-host disease, in patients treated with
- Determine disease-free and overall survival of patients treated with this regimen.
- Determine treatment-related mortality of patients treated with this regimen.
OUTLINE: This is a uncontrolled, pilot study.
- Nonmyeloablative conditioning regimen: Patients receive fludarabine IV over 30 minutes
daily on days -6 to -2 and cyclophosphamide IV over 2 hours on day -6 and undergo
low-dose total-body irradiation (TBI) on day 0.
- Unrelated allogeneic umbilical cord blood transplantation (UCBT): After completion of
TBI, patients undergo 1 or 2 unrelated allogeneic UCBTs on day 0.
- Post-transplant immunosuppression: Patients receive oral or IV cyclosporine daily
beginning on day -3 and continuing until day 180 and oral or IV mycophenolate mofetil
twice daily on days 0-30.
Patients are followed periodically for 1 year after transplantation.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Primary Purpose: Treatment
Gordon L. Phillips, MD
James P. Wilmot Cancer Center
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|