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Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT05534620•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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants with AML or MDS who qualify for treosulfan-based conditioning treatment, indicated for alloHSCT.
•2. Have available matched-related, matched-unrelated, haploidentical, or a mismatched unrelated donor. Match is defined as at least 9/10 allele matches in human leucocyte antigen (HLA)-A, -B, -C, -DRB1 and DQB1 or 7/8 allele matches in (HLA)-A, -B, -C and -DRB1. Haploidentical is defined as any family member with 2, 3 or 4 (out of 8) HLA-loci mismatch; at the same time, the donor and recipient must be HLA identical for at least one antigen at the following genetic loci: (HLA)-A, -B, -C, and -DRB1. High resolution deoxyribonucleic acid (DNA) typing must be used.
•3. Are adults of either sex, age 18-80 years (inclusive).
•4. Have a Karnofsky Index of greater than or equal to (\>=) 60 percent (%).
•5. Have a creatinine clearance (CLcre) \>=30 milliliters per minute (mL/min) (Cockcroft Gault: normal renal function: CLcre \>=90 mL/min, mild renal impairment: CLcre 60-89 mL/min, moderate renal impairment: CLcre 30-59 mL/min).
•6. Are willing to consent to using a highly effective method of birth control, such as condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner while on treatment and for at least 6 months thereafter, if females of childbearing potential (defined according to the Clinical Trials Facilitation and Coordination Group guidelines as a fertile woman, following menarche and until becoming postmenopausal unless permanently sterile) and males capable of reproduction.
•7. Have a negative pregnancy test, if females of childbearing potential.
•8. Have provided a written informed consent.

Exclusion Criteria

•* Have severe renal impairment, example, are on dialysis, have renal transplantation history, or calculated CLcre of less than (\<) 30 mL/min.
•* Have severe pulmonary impairment, single-breath diffusion capacity of the lung for carbon monoxide (DLCO) (haemoglobin adjusted) or forced expiratory volume (FEV1) of \<50%, or severe dyspnoea at rest or requiring oxygen supplementation.
•* Have moderate or severe hepatic impairment (Child-Pugh B or C classification, respectively) and with documented medical history of chronic liver disease..
•2. 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 \[ms\]).
•3. Have Fredericia-corrected QTc (QTcF) interval \>450 ms in men and \>470 ms in women.
•4. Have active malignant involvement of the central nervous system.
•5. Are human immunodeficiency virus (HIV) positive or have an active non controlled infectious disease under treatment including fungal infection, active viral liver infection, or known severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) viral infection at the time of enrolment.
•6. Have previously had more than one alloHSCT.
•7. Have pleural effusion or ascites of \>1.0 liters (L).
•8. Are pregnant or breast-feeding.
+5 more criteria

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

Key Dates

Start Date

February 1, 2024

Primary Completion Date

March 1, 2026

Completion Date

December 1, 2026

Last Updated

December 2, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukaemia (AML)Myelodysplastic Syndrome (MDS)Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Interventions

Treosulfan

DRUG

Fludarabine

DRUG

Contacts

Clinical Trial Information

CONTACT

+49 40103 8006-0 ClinicalTrialInformation@medac.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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