Finding studies
Finding studies
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Lead
Masonic Cancer Center, University of Minnesota
With
OBJECTIVES: Primary * 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. Secondary * 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 this regimen. * 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 to -1. * 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.
Age
0–45
Sex
ALL
Healthy volunteers
Not accepted
