Trial reportThe Lancet. Haematology2018
Fludarabine with a higher versus lower dose of myeloablative timed-sequential busulfan in older patients and patients with comorbidities: an open-label, non-stratified, randomised phase 2 trial.
Trial report in The Lancet. Haematology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed.
- Randomized Trial of Two Fractionation Schedules of Myeloablative Busulfan with Fludarabine and Cladribine in Acute Myeloid Leukemia or Myelodysplastic Syndromes.Transplantation and cellular therapy · 2026Trial
- Myeloablative fractionated busulfan for allogeneic stem cell transplant in older patients or patients with comorbidities.Blood advances · 2023Trial
- A myeloablative fractionated busulfan conditioning regimen with post-transplant cyclophosphamide in HLA-matched and haploidentical transplantation: results of a phase II study.Haematologica · 2022Trial
- Myeloablative Fractionated Busulfan With Fludarabine in Older Patients: Long Term Disease-Specific Outcomes of a Prospective Phase II Clinical Trial.Transplantation and cellular therapy · 2021Trial
- Trial
- Real-world experience of treosulfan in allogeneic stem cell transplantation in adult patients with myeloid malignancies. Spanish Group of SCT and Cell Therapy (GETH-TC).Bone marrow transplantation · 2026Article
- Seizure Prophylaxis and its Impact on Busulfan Pharmacokinetics and Dosing in a Novel Timed Sequential Protocol: MD Anderson Experience.Transplantation and cellular therapy · 2025Article
- Post-Transplant Cyclophosphamide-Based GVHD Prophylaxis After Peripheral Blood Stem Cell HLA Identical Transplantation in Patients with Lymphoma: A Prospective Observational Study.Life (Basel, Switzerland) · 2025Article
- Impact of type of induction therapy on outcomes in older adults with AML after allogeneic stem cell transplantation.Blood advances · 2023Article
- Enhanced Recovery Stem-Cell Transplantation: Multidisciplinary Efforts to Improve Outcomes in Older Adults Undergoing Hematopoietic Stem-Cell Transplant.JCO oncology practice · 2023Article
- Fludarabine plus reduced-intensity busulfan versus fludarabine plus myeloablative busulfan in patients with non-Hodgkin lymphoma undergoing allogeneic hematopoietic cell transplantation.Annals of hematology · 2023Article
- Acute graft-versus-host disease is the foremost cause of late nonrelapse mortality.Bone marrow transplantation · 2021Article
- Kidney injury and disease in patients with haematological malignancies.Nature reviews. Nephrology · 2021Review
- Article
- Optimizing Transplant Approaches and Post-Transplant Strategies for Patients With Acute Myeloid Leukemia.Frontiers in oncology · 2021Review
- Summary of the Highlights of 2019 ASTCT Meeting by iNDUS BMT Group at Chennai, India.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2019Review
Corrections and comments
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Authors and funding
29 authors.
Funding
Abstract
backgroundHaemopoietic stem-cell transplantation (HCT) conditioning regimens that can reduce risk of relapse without increasing non-relapse mortality are needed. We aimed to test the safety of timed-sequential delivery of low-dose versus high-dose myeloablative busulfan in older patients and patients with comorbidities.
methodsThis non-stratified, open-label, randomised phase 2 trial was done at The University of Texas MD Anderson Cancer Center (Houston, TX, USA). Patients with haematological cancers aged between 5 and 75 years were eligible to participate in the study. Patients who had HIV or uncontrollable infections were excluded. Eligible patients were randomly assigned (1:1 by a computer-generated programme in block sizes of four) to receive a total intravenous busulfan dose to achieve an area under the curve of 16 000 μmol/min (16K group) or 20 000 μmol/min (20K group) on the basis of pharmacokinetic analysis, plus intravenous fludarabine 40 mg/m
findingsBetween April 18, 2012, and Dec 9, 2015, 98 patients were enrolled. 49 patients were randomly assigned to the 16K group and 49 to the 20K group, one of which was removed from the study before starting the intervention. Median age was 60 years (IQR 54-67). 50 (52%) patients had an HCT-specific comorbidity index score of 3 or more, and 41 (42%) had a high or very high Disease Risk Index score. Day 100 non-relapse mortality was 4% (95% CI 0-10) in the 16K group and 6% (0-13) in the 20K group (p=0·65). Infection was the most common grade 3-5 toxicity in both the 20K group (25 [52%] of 48 patients) and the 16K group (24 [49%] of 49 participants). Mucositis (nine [19%] of 48 patients vs three [6%] of 49 patients), idiopathic pneumonia syndrome (nine [19%] of 48 patients vs two [4%] of 49 patients), and culture-negative neutropenic fever (16 [33%] of 48 patients vs eight [16%] of 49 patients) were more common in the 20K group than in the 16K group.
interpretationMyeloablative doses of busulfan administered in a timed-sequential manner with fludarabine is associated with low non-relapse mortality in older patients and patients with comorbidities. Additional studies are required to show whether this approach can reduce the risk of relapse.
fundingCancer Center Support Grant (US National Cancer Institute, National Institutes of Health).
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