Cord Blood Transplantation for Hematologic Malignancies and Bone Marrow Failure Syndromes
OBJECTIVES: I. Determine the safety, efficacy, and toxicity of using cord blood as a source
for stem cell transplantation in patients with hematologic malignancies.
OUTLINE: Patients undergo autologous bone marrow harvesting or peripheral stem cell
collection prior to transplant regimen, unless the patient has acute leukemia in relapse,
aplastic anemia, or myelodysplastic syndrome. Arm I: Patients eligible to undergo total body
irradiation (TBI) first receive cyclophosphamide IV over 2 hours on days -5 and -4, then
undergo TBI twice a day on days -3 to -1. Patients also receive antithymocyte globulin (ATG)
IV over 10 hours on days -3 to -1. Cord blood is infused on day 0. Arm II: Patients not
eligible to receive TBI receive oral busulfan every 6 hours on days -7 to -4 for a total of
16 doses. Cyclophosphamide, ATG, and cord blood are then administered as in arm I. All
patients receive cyclosporine on days -2 to 180, methylprednisolone on days 5-180, and
filgrastim (G-CSF) from day 1. Patients are followed weekly until day 180 and then monthly
for 2 years.
PROJECTED ACCRUAL: A total of 20 patients (10 patients per arm) will be accrued for this
study within 4 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety, efficacy and toxicity of using cord blood as a source for stem cell transplantation in patients with hematologic malignancies.
weekly until day 100+, then yearly
Barbara Jean Bambach, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|