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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: Recruiting Phase 1 study of Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML), sponsored by medac.
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 84-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (57% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-02-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05534620 shows while recruiting
NCT05534620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 84-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (57% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome (MDS)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05534620's enrollment target sits among peer trials
36 13th of 19 higher than 6 of 19 other Myelodysplastic Syndrome (MDS) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome (MDS) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome
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-
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
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-
A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
RECRUITING · Phase 1
-
CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant
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-
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN
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-
Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations
ACTIVE NOT RECRUITING · Phase 1
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