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NCT05534620 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML), sponsored by medac.

Recruiting
Registry status
Phase 1
Development phase
36
Enrollment target
4
Study locations

NCT05534620 is a Phase 1 study of Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML) that is actively recruiting participants, run by medac. The registered enrollment target is 36 participants, below the 91-participant average among 17 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (60% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT05534620, a Phase 1 study of Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML), is actively recruiting participants, sponsored by medac.

RECRUITING
Registry status
Phase 1
Development phase
36 participants
Enrollment target
4
Study locations

Study 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 Studied

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

Interventions

  • DRUG Fludarabine
  • DRUG Treosulfan

Study Locations (4)

Illinois

  • University of Illinois - Chicago

New York

  • Memorial Sloan Kettering Cancer Center - New York

Ohio

  • The Ohio State University - Columbus

Virginia

  • VCU Massey Cancer Center - Richmond

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2024-02-01
Est. Completion 2026-12
Phase Phase 1

Sponsor

medac

4 total trials

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What the Registry Record Tells You About NCT05534620

The ClinicalTrials.gov registry entry for NCT05534620 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 17 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (60% lower). The listed sponsor is medac, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Myelodysplastic Syndrome (MDS) appearing as the primary indexed condition, and to 2 interventions - of which Fludarabine is the first listed.

NCT05534620 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Illinois, New York, Ohio.

Frequently Asked Questions

What is clinical trial NCT05534620 about?

NCT05534620 is a clinical study titled "Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics". 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 a...

What is the current status of trial NCT05534620?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2024-02-01. Estimated completion is 2026-12.

What conditions does trial NCT05534620 study?

This clinical trial studies the following conditions: Myelodysplastic Syndrome (MDS), Acute Myeloid Leukaemia (AML), Allogeneic Hematopoietic Stem Cell Transplantation (HSCT).

What interventions are being tested in trial NCT05534620?

The interventions under investigation include: Fludarabine (DRUG), Treosulfan (DRUG).

Who is sponsoring clinical trial NCT05534620?

This trial is sponsored by medac, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05534620 being conducted?

This trial has 4 study locations across Illinois, New York, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.