drugset / Trial / NCT05534620
Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics
NaSingle-groupOpen-labelOther
Summary
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.
Timeline
- Start
- 2024-02-01
- Primary completion
- 2025-05-14
- Completion
- 2025-06-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Treosulfan | Small molecule | 10 g | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |