Finding studies
Finding studies
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Lead
Fred Hutchinson Cancer Center
With
OBJECTIVES: Primary * To estimate the probability of survival at 1 year in patients with advanced hematological malignancies or other diseases treated with non-myeloablative unrelated donor umbilical cord blood transplantation. Secondary * Six month non-relapse mortality. * Chimerism at days 7, 14, 21, 28, 56, and 80, at 6 months, and at 1 and 2 years. * To determine the incidence of neutrophil engraftment at day 42. * To determine the incidence of platelet engraftment at 6 months. * To determine the incidence of grade II-IV and III-IV acute graft-versus-host-disease (GVHD) at day 100. * To determine the incidence of chronic GVHD at 1 year. * To determine the incidence of clinically significant infections at 6 months and at 1 and 2 years. * To determine the probability of progression-free survival at 1 and 2 years. * To determine the probability of survival at 2 years. * To determine the incidence of relapse or disease progression at 1 and 2 years. OUTLINE: Patients are stratified according to disease status and prior therapy (hematologic malignancy or other disease that was treated with an autologous stem cell transplant or ≥ 2 courses of multiagent chemotherapy within the past 3 months vs hematologic malignancy or other disease that was treated with an autologous stem cell transplant \> 12 months ago or with ≤ 1 course of multiagent chemotherapy or immunosuppressive chemotherapy within the past 3 months vs refractory leukemia or lymphoma for which patient was rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy). * Conditioning regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV on day -6. Patients also undergo total body irradiation on day -1. Some patients also receive anti-thymocyte globulin IV on days -6 to -4. * Umbilical cord blood transplantation (UCBT): Patients undergo UCBT on day 0. * Immunosuppressive therapy (graft-versus-host disease prophylaxis): Patients receive cyclosporine IV over 1 hour or orally (as tolerated) every 8 or 12 hours beginning on day -3 and continuing for approximately 6 months. Patients also receive mycophenolate mofetil IV every 8 hours on days -3 to 5 and then orally on days 6-30. After completion of study treatment, patients are followed at 6 months and then annually thereafter.
Age
0–69
Sex
ALL
Healthy volunteers
Not accepted
