Acute Myeloid Leukemia Clinical Trial
Official title:
Treatment of Hematologic Malignancies With High-Dose Chemo-Radiotherapy Followed by Single-Unit or Double-Unit Cord Blood Transplantation: A Phase II Study
The purpose of this study is to evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units meeting a predetermined total minimum cell dose of 2.0 x 10 to the seventh total nucleated cell (TNC)/kg.
This is a non-randomized, phase II protocol to evaluate engraftment of cord blood after
treatment with myeloablative conditioning of fludarabine, total body irradiation and
cyclophosphamide. All patients will receive tacrolimus and mycophenolate mofetil as
prophylaxis for graft-vs-host disease.
Conditioning Regimen:
- Days -10 to -7: Fludarabine 30mg/m2/day IV
- Days -7 to -4: TBI 165 centigray BID
- Days -3 to -2: Cyclophosphamide 40mg/kg/day IV
Day 0: Infusion of Cord Blood Cells
Graft-vs-Host Disease Prophylaxis
- Day -1: Start tacrolimus 0.03mg/kg/day IV
- Day 0: Start MMF 7.5mg/kg IV BID
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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