Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Case Comprehensive Cancer Center
OBJECTIVES: * Determine the incidence and severity of acute toxicity in patients with hematologic malignancies or severe aplastic anemia treated with a non-myeloablative conditioning regimen followed by umbilical cord blood transplantation. * Determine the incidence and severity of acute and chronic graft-versus-host-disease in patients treated with this regimen. * Determine the incidence of relapse, disease-free survival, and overall survival of patients treated with this regimen. * Determine the survival rate at 100 days post-transplantation in patients treated with this regimen. * Determine the incidence of regimen-related complications (infection, hepatic veno-occlusive disease, and interstitial pneumonitis) in patients treated with this regimen. * Determine the incidence of primary and secondary graft failure in patients treated with this regimen. * Determine the rates and kinetics of donor-derived lymphoid, myeloid, neutrophil, RBC, and platelet engraftment in patients treated with this regimen. OUTLINE: Patients receive a non-myeloablative conditioning regimen comprising fludarabine IV over 30 minutes on days -8 to -4, cyclophosphamide IV over 2 hours on days -3 to -2, and anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1. Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1. Patients undergo multiple unit umbilical cord blood transplantation on days 0-1. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover. Patients are followed monthly for 6 months; at 9, 12, 14, 16, 18, and 24 months; and then annually thereafter. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
Age
0–120
Sex
ALL
Healthy volunteers
Not accepted
