Non-Hodgkin Lymphoma Clinical Trial
Official title:
Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) as a Conditioning for Autologous Stem Cell Transplantation in Patients With B Cell Lymphoma Except for Diffuse Large B Cell Lymphoma
The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide, cytarabine and melphalan (BuEAM) as a conditioning for autologous stem cell transplantation in patients with non-Hodgkin lymphoma.
High-dose conditioning regimens commonly used in patients with non-Hodgkin lymphoma are BEAM
(BCNU, etoposide, cytarabine, and melphalan), BEAC (BCNU, etoposide, cytarabine, and
cyclophosphamide), CBV (cyclophosphamide, carmustine, and etoposide), and combination
regimen with total body irradiation. Three-year progression free survival of patients with
non-Hodgkin lymphoma 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 stem cell
transplantation have also been studied with autologous stem cell transplantation 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
intravenous busulfan, cyclophosphamide, and etoposide was found to be well tolerated and
seemed to be effective in patients with aggressive non-Hodgkin lymphoma. Another prospective
study for patients with multiple myeloma showed that intravenous busulfan plus melphalan
conditioning regimen made no grade 3-4 non-hematologic complication.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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