RecruitingPhase 1NCT05534620

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


Sponsor

medac GmbH

Enrollment

36 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how kidney function and race/ethnicity affect the way the body processes treosulfan, a chemotherapy drug used as part of the preparation regimen before a stem cell transplant (allogeneic HSCT) in people with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). **You may be eligible if...** - You are 18–80 years old with AML or MDS who qualifies for treosulfan-based conditioning before a stem cell transplant - You have a suitable donor (matched, haploidentical, or partially matched) - Your kidney function is at least moderately functional (creatinine clearance ≥30 mL/min) - Your Karnofsky performance score is 60% or higher - You agree to use effective contraception if applicable **You may NOT be eligible if...** - You have severe kidney failure (creatinine clearance below 30 mL/min) - You do not have an available donor - You do not qualify for a stem cell transplant by your medical team's assessment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTreosulfan

IV infusion

DRUGFludarabine

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

View Full Details on ClinicalTrials.gov

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NCT05534620


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