OncoMatch/Clinical Trials/NCT05534620
Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics
Is NCT05534620 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Treosulfan and Fludarabine for acute myeloid leukaemia (aml).
Treatment: Treosulfan · Fludarabine — This study aim is to assess, if treosulfan pharmacokinetics are influenced by declined renal function and by race/ethnicity of patients. The study also aims to determine an appropriate safe dose of treosulfan, when patient's renal function is impaired. The participants of this study are undergoing allogenic hematopoietic stem cell transplantation for treatment of acute myeloid leukemia or myelodysplastic syndrome.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Prior therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: no more than one prior alloHSCT allowed
Have previously had more than one alloHSCT.
Lab requirements
Kidney function
creatinine clearance (CLcre) >=30 mL/min required; severe renal impairment (on dialysis, renal transplantation history, or CLcre <30 mL/min) excluded
Liver function
moderate or severe hepatic impairment (Child-Pugh B or C classification, respectively) and with documented medical history of chronic liver disease [excluded]
Cardiac function
known coronary artery disease, history of myocardial infarction, cardiac dysfunction (including cardiomyopathies, heart failure NYHA Class II and above, arrhythmias including paroxysmal and permanent atrial fibrillation, interventricular conduction delay and/or bundle branch block [QRS >120 ms]), Fredericia-corrected QTc (QTcF) interval >450 ms in men and >470 ms in women [excluded]
Have severe renal impairment, example, are on dialysis, have renal transplantation history, or calculated CLcre of less than (<) 30 mL/min. Have moderate or severe hepatic impairment (Child-Pugh B or C classification, respectively) and with documented medical history of chronic liver disease. Have a known coronary artery disease, history of myocardial infarction, cardiac dysfunction, including cardiomyopathies, heart failure (New York Heart Association Class II and above), and cardiac arrhythmias (including paroxysmal and permanent atrial fibrillation), interventricular conduction delay and / or bundle branch block (QRS duration >120 milliseconds [ms]). Have Fredericia-corrected QTc (QTcF) interval >450 ms in men and >470 ms in women.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Illinois · Chicago, Illinois
- Memorial Sloan Kettering Cancer Center · New York, New York
- The Ohio State University · Columbus, Ohio
- VCU Massey Cancer Center · Richmond, Virginia
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