Spots Global Cancer Trial Database for Treatment of Hematologic Malignancies With Single-Unit or Double-Unit Cord Blood Transplantation

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Trial Identification

Brief Title: Treatment of Hematologic Malignancies With Single-Unit or Double-Unit Cord Blood Transplantation

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

Study ID: NCT00328237

Conditions

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Non-Hodgkin Lymphoma

Myelodysplastic Syndromes

Interventions

Cord Blood Transplant

Study Description

Brief Summary: 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.

Detailed Description: 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