Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS)
Sponsor study identifier
interventional
222
1 country
9
Study Start
October 19, 2023
Actual (reported)Primary Completion
October 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15\~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (\<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 8, 2023
Actual (reported)August 15, 2023
Actual (reported)October 19, 2023
Actual (reported)October 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
disease-free survival
event defined as relapse and death of any causes
2 year
overall survival
2 year
incidence of relapse
2 year
non relapse mortality
day 100
non relapse mortality
2 year
Patients receive fludarabine, busulfan and melphalan as conditioning regimen
Patients receive fludarabine and busulfan as conditioning regimen
FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2
FLudarabine 150mg/m2 + Busulfan 12.8mg.kg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Fludarabine, busulfan and melphalan
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Fludarabine and Busulfan
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordFujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Zhongshan Hospital, Xianmen University
Xiamen, Fujian, 361004, China
Chun Wang
Go Broad Health Center, Zhaxin Hospital
First Submitted
August 8, 2023
First Posted
August 15, 2023
Study Start
October 19, 2023
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
923th Hospital PLA
Nanning, Guangxi, 530021, China
First Affiliated Hospital of Nanjin Medical Unviersity
Nanjin, Jiangsu, 210029, China
First Affiliatied Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
Shanghai No10 Hospital
Shanghai, Shanghai Municipality, China
920th Hospital PLA
Kunming, 650000, China
Shanghai No 6 Hospital
Shanghai, China
October 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 18, 2025
Record last verified: 2025-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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