Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies

Trial Information

Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies

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.