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Several high-dose therapy (HDT) conditioning regimens have been used to treat non-Hodgkin's lymphoma (NHL), such as bis-chloroethylnitrosourea (BCNU)/etoposide/cytosine arabinoside/melphalan (BEAM), BCNU/etoposide/cytosine arabinoside/cyclophosphamide (BEAC), and cyclophosphamide/BCNU/etoposide (CBV). BCNU is an active drug in HDT of NHL, but the supply is limited in some countries, including Korea. Busulfan has been used in allogeneic and autologous stem cell transplantation (ASCT). This phase II study evaluated the efficacy of busulfan/melphalan/etoposide (BuME) as a conditioning regimen for HDT in relapsed or high-risk NHL. The regimen consisted of intravenous busulfan (3.2 mg/kg/day) on days -8, -7, and -6, etoposide (400 mg/m /day) on days -5 and -4, and melphalan (50 mg/m /day) on days -3 and -2. A total of 46 patients were included in the study, with 36 (78.3%) achieving a complete response after ASCT. The 2-year progression-free survival (PFS) and overall survival (OS) rates for all patients were 46.7% (95% CI, 31.8-60.4%) and 63.7% (95% CI, 47.7-76.0%), respectively. There was no development of veno-occlusive disease and no treatment-related deaths within 100 days after ASCT. These results indicate that a BuME regimen is well-tolerated and effective for patients with relapsed or high-risk NHL, and may be comparable to some previously used regimens. This regimen may be useful as a substitute for BCNU-containing regimens.
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http://dx.doi.org/10.1111/tri.13664 | DOI Listing |
Pharmaceutics
August 2025
Department of Clinical Pharmacy, School of Pharmacy, Faculty of Medicine, Hebrew University of Jerusalem, P.O.Box 12272, Jerusalem 9112102, Israel.
Busulfan is a key component of myeloablative conditioning regimens in hematopoietic stem cell transplantation (HSCT) for pediatric patients with acute myeloid leukemia, solid tumors, and certain non-malignant diseases. This study compares the clinical outcomes of once-daily (BU1) versus four-times-daily (BU4) busulfan dosing regimens in pediatric HSCT recipients. A retrospective analysis was conducted on 70 pediatric patients who underwent HSCT at Hadassah Medical Center between June 2018 and October 2023.
View Article and Find Full Text PDFLancet Reg Health West Pac
August 2025
Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Background: Outcomes of older patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem-cell transplantation (allo-HSCT) remain unsatisfactory. The primary objective of this trial was to establish whether decitabine combined with reduced-intensity conditioning (RIC) regimen could improve overall survival (OS) for this population in composite complete remission (CRc).
Methods: We conducted a single-arm, phase 2 trial at six hospitals in China.
Clin Pharmacol Ther
September 2025
Department of Clinical Pharmacology and Pharmacy, Amsterdam UMC Location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Busulfan is administered intravenously in conditioning regimens prior to allogeneic hematopoietic stem cell transplantation (HSCT), with model-informed precision dosing (MIPD) targeting a 4-day cumulative AUC of 80-100 mg*hour/L. Three pharmacokinetic (PK) models-Bognar, Langenhorst, and McCune-were evaluated using data with a minimum of 1 and a median of 2 PK sampling days from pediatric and adult patients at two tertiary hospitals in the Netherlands. Simulations with the best-performing model evaluated dose optimization and the role of therapeutic drug monitoring (TDM).
View Article and Find Full Text PDFHaematologica
June 2025
Division of Hematology/Oncology, Department of Medicine, University of Illinois at Chicago; Chicago, IL, USA; Cancer Center, University of Illinois at Chicago, Chicago, IL.
The intensity of the conditioning regimen in hematopoietic stem cell transplantation (HSCT) correlates with the risk of relapse, however its potential benefit may be outweighed by the associated risk of toxicity. The addition of total marrow irradiation (TMI) to myeloablative conditioning provides an opportunity to increase intensity with minimal additional toxicity. In this phase 2 clinical trial, 30 patients with high-risk myeloid malignancies received an allogeneic HSCT using myeloablative TMI at 9Gy in combination with standard myeloablative fludarabine/intravenous busulfan (FluBu4) chemotherapy.
View Article and Find Full Text PDFTransplant Cell Ther
September 2025
Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address:
High dose busulfan (Bu) is widely used in conditioning regimens for patients undergoing hematopoietic stem cell transplantation. Like all alkylating agents, it has significant inter-patient pharmacokinetic (PK) variability. The influence of Bu plasma exposure on treatment outcomes and toxicities have led to the continued use of therapeutic drug monitoring of Bu.
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