The purpose of this study is to evaluate the OS, RFS, and TRM after HCT with low-dose total body irradiation, fludarabine, and busulfan conditioning.
Conventional allogeneic hematopoietic cell transplantation (HCT) for patients with hematological malignancies involves conditioning with high doses of systemic chemo/radiation therapy such as cyclophosphamide (CY) plus 1200 or 1000 cGy total body irradiation (TBI; CY/TBI) or busulfan (Bu) / CY (BuCy). Unfortunately, such regimens have been associated with significant toxicities, limiting their use to otherwise healthy, relatively young patients. Recently, Fludarabine plus 4 day dose of busulfan (FluBu4) containing myeloablative regimen has been introduced successfully without increasing transplant-related mortality (TRM). To improve transplant outcomes without increasing the risk of recurrence, Russell et al introduced 400cGy of TBI with antithymocyte (ATG, 4.5mg/Kg) into FluBu4 regimen with successful outcomes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Fludarabine ( 30mg/m2, iv, D-7\~D-2) Busulfan (3.2mg/kg, iv, D-6\~D-3) Total body irradiation (200cGy/day, D-2,-1)
Dong Hwan Kim
Seoul, South Korea
RECRUITINGprogression free survival
Time frame: one year
relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD
Time frame: one year
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