Non Hodgkin's Lymphoma Clinical Trial
Official title:
Busulfan, Etoposide, Cytarabine and Melphalan (BuEAM) as a Conditioning for Autologous Stem Cell Transplantation in Patients With Diffuse Large B Cell Lymphoma (DLCBL) Previously Treated With Rituximab Based Regimen
The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide, cytarabine and melphalan (BuEAM) including intravenous busulfan instead of BCNU of standard BEAM as a conditioning for autologous stem cell transplantation in patients with NHL.
Among the high-dose conditioning regimens commonly used in patients with NHL are BEAM (BCNU,
etoposide, cytarabine, and melphalan), BEAC (BCNU, etoposide, cytarabine, and
cyclophosphamide), CBV (cyclophosphamide, carmustine, etoposide), and combination regimen
with total body irradiation. Three-year progression free survival of patients with NHL
received above high-dose chemotherapy followed by autologous stem cell rescue was reported
as 40-50%, which is still unsatisfactory.
Busulfan (Bu)-based preparative regimens, which are commonly used with allogeneic SCT have
also been studied with ASCT for lymphomas.
The development of intravenous busulfan achieved 100% bioavailability bypassing the oral
route and increased safety and reliability of generating therapeutic busulfan levels,
maximizing efficacy.
Recently, one prospective study showed that a combination conditioning regimen of i.v.
busulfan, cyclophosphamide, etoposide was found to be well tolerated and seemed to be
effective in patients with aggressive NHL.
Another prospective study for multiple myeloma patients showed that i.v. busulfan and
melphalan conditioning regimen made no grade 3-4 non-hematological complication.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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