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RECRUITING
NCT05534620
PHASE1

Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics

Sponsor: medac GmbH

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-02-01

Completion Date

2026-12

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

DRUG

Treosulfan

IV infusion

DRUG

Fludarabine

IV infusion

Locations (4)

University of Illinois

Chicago, Illinois, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

VCU Massey Cancer Center

Richmond, Virginia, United States