RecruitingPhase 1

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

United States36 participantsStarted 2024-02-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants with AML or MDS who qualify for treosulfan-based conditioning treatment, indicated for alloHSCT.
✓. 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.
✓. Are adults of either sex, age 18-80 years (inclusive).
✓. Have a Karnofsky Index of greater than or equal to (\>=) 60 percent (%).
✓. 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).
✓. 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.
✓. Have a negative pregnancy test, if females of childbearing potential.
✓. Have provided a written informed consent.

Exclusion criteria

What they're measuring

Area Under the Concentration-time Curve From Time of Administration to the Last Measurable Concentration (AUClast) for Treosulfan

Timeframe: Day -4 and Day -2: Pre-dose, at end of infusion and at 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose

Area Under the Concentration-time Curve From Time of Administration to Time of Infinity (AUCinf) for Treosulfan

Timeframe: Day -4 and Day -2: Pre-dose, at end of infusion and at 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose

Trial details

NCT IDNCT05534620

Sponsormedac GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Clinical Trial Information

+49 40103 8006-0 ClinicalTrialInformation@medac.de

View on ClinicalTrials.gov More Acute Myeloid Leukaemia (AML) trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants with AML or MDS who qualify for treosulfan-based conditioning treatment, indicated for alloHSCT.
✓. 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.
✓. Are adults of either sex, age 18-80 years (inclusive).
✓. Have a Karnofsky Index of greater than or equal to (\>=) 60 percent (%).
✓. 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).
✓. 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.
✓. Have a negative pregnancy test, if females of childbearing potential.
✓. Have provided a written informed consent.

Exclusion criteria

What they're measuring

Area Under the Concentration-time Curve From Time of Administration to the Last Measurable Concentration (AUClast) for Treosulfan

Timeframe: Day -4 and Day -2: Pre-dose, at end of infusion and at 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose

Area Under the Concentration-time Curve From Time of Administration to Time of Infinity (AUCinf) for Treosulfan

Timeframe: Day -4 and Day -2: Pre-dose, at end of infusion and at 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose