Trials / Recruiting
RecruitingNCT05534620
Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics
An Open-label, Non-randomized, Prospective Trial to Evaluate the Effect of Renal Function Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics in Patients With AML or MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- medac GmbH · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Acute Myeloid Leukaemia (AML)
- Myelodysplastic Syndrome (MDS)
- Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Treosulfan | IV infusion |
| DRUG | Fludarabine | IV infusion |
Timeline
- Start date
- 2024-02-01
- Primary completion
- 2026-03-01
- Completion
- 2026-12-01
- First posted
- 2022-09-09
- Last updated
- 2025-12-02
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05534620. Inclusion in this directory is not an endorsement.