Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Hematological Diseases Using a Non-Myeloablative Preparative Regimen
- Determine the safety of nonmyeloablative preparative regimen comprising
cyclophosphamide, fludarabine, and total-body irradiation with or without
anti-thymocyte globulin, in terms of non-relapse mortality at day 100
post-transplantation, in patients with advanced hematologic malignancies, metastatic
breast cancer, or renal cell cancer who are undergoing umbilical cord blood
transplantation from an unrelated donor.
- Determine the hematopoietic recovery and degree of chimerism on days 21, 60, 100, 180,
and 360 post-transplantation.
- Determine the incidence of grade II-IV and III-IV acute graft-versus-host disease
(GVHD) by day 100 post-transplantation and chronic GVHD at 1 year post-transplantation.
- Evaluate the risk of relapse at 1 year post-transplantation.
- Determine overall survival at 1 year post-transplantation.
- Nonmyeloablative preparative regimen: Patients receive cyclophosphamide IV over 2 hours
on day -6 and fludarabine IV over 1 hour on days -6 to -2. Patients also undergo
total-body irradiation on day -1. Some patients* may also receive anti-thymocyte
globulin (ATG) IV twice daily on days -6 to -4.
NOTE: *Patients who have not had prior combination chemotherapy within the past 3 months OR
who only received 1 prior induction course for the treatment of acute lymphoblastic
leukemia, acute myeloid leukemia, myelodysplastic syndromes, or chronic myelogenous leukemia
in blast crisis receive ATG during the preparative regimen.
- Umbilical cord blood transplantation (UCBT): Patients undergo UCBT from an unrelated
donor on day 0.
- Graft-versus-host disease prophylaxis: Patients receive cyclosporine IV over 2 hours or
orally 2-3 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 twice
daily beginning on day -3 and continuing until day 30 or until 7 days after
After transplantation, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Safety as assessed by a non-relapse mortality < 30% within day 100
Claudio G. Brunstein, MD, PhD
Masonic Cancer Center, University of Minnesota
United States: Federal Government