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NCT06923488 · ClinicalTrials.gov registry record · Phase 1
Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes
A Phase 1 study of Myelodysplastic Syndromes, sponsored by West Virginia University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT06923488 is a Phase 1 study of Myelodysplastic Syndromes that is actively recruiting participants, run by West Virginia University. The registered enrollment target is 26 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06923488, a Phase 1 study of Myelodysplastic Syndromes, is actively recruiting participants, sponsored by West Virginia University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this interventional clinical trial is to evaluate the safety and tolerability of leflunomide in combination with decitabine as treatment for patients with relapsed or refractory myelodysplastic syndromes (R/R MDS). The main question this study aims to answer are to evaluate and estimate the maximum tolerated doses and/or biologically active doses of the combination of leflunomide-decitabine in participants. Decitabine will be administered at a dose of 20 mg/m2 by continuous intravenous infusion over one hour repeated daily for 5 days with repeating cycle every 4 weeks. Leflunomide is administered orally at 10 to 20 mg once daily (without a loading dose) for 14 to 21 days, as part of a 28-day treatment cycle in adult subjects with R/R MDS. After 12 cycles (study duration) responding patients can continue progression with the assigned doses.
Conditions Studied
Interventions
- DRUG Decitabine
- DRUG Leflunomide 10mg
- DRUG Leflunomide 20mg
Study Locations (1)
West Virginia
- West Virginia University Cancer Institute - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2025-08 |
| Est. Completion | 2028-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06923488
The ClinicalTrials.gov registry entry for NCT06923488 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (91% lower). The listed sponsor is West Virginia University, which has 122 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 3 interventions - of which Decitabine is the first listed.
NCT06923488 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.
Frequently Asked Questions
What is clinical trial NCT06923488 about?
NCT06923488 is a clinical study titled "Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes". The goal of this interventional clinical trial is to evaluate the safety and tolerability of leflunomide in combination with decitabine as treatment for patients with relapsed or refractory myelodysplastic syndromes (R/R MDS). The main question this study aims to answer are to evaluate and estimate...
What is the current status of trial NCT06923488?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2025-08. Estimated completion is 2028-10.
What conditions does trial NCT06923488 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes.
What interventions are being tested in trial NCT06923488?
The interventions under investigation include: Decitabine (DRUG), Leflunomide 10mg (DRUG), Leflunomide 20mg (DRUG).
Who is sponsoring clinical trial NCT06923488?
This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06923488 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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