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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Busulfan 3.2 mg/kg/d for 2 days, etoposide 400 mg/m2/d for 2 days, cytarabine 1 g/m2 for 2 days, and melphalan 140 mg/m2 for 1 day
Inje University Busan Paik Hospital, Inje University College of Medicine
Busan, South Korea
RECRUITINGSeoul National University Hospital, Seoul National University College of Medicine
Seoul, South Korea
RECRUITINGSeverance Hospital, Yonsei University College of Medicine
Seoul, South Korea
Progression-free survival
Time frame: After 3 years
Overall survival
Time frame: After 3 years
Response rate according to the International Working Group criteria
Time frame: After 2 months
Adverse events
Time frame: From start of conditioning to discharge
Pharmacogenetic study
Pharmacogenetic study for predictive or prognostic markers using blood samples
Time frame: After 3 years
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Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
RECRUITINGUlsan University Hospital, University of Ulsan College of Medicine
Ulsan, South Korea
RECRUITING