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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: Recruiting Phase 1 study of Myelodysplastic Syndromes, sponsored by West Virginia University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentages of incidences of RLTs defined as: * A need to reduce the dose of one or both of the treatments * Discontinue the treatment due to dose limiting toxicities, AE/SAE * Be withheld at the discretion of the treating physician and on the basis of the expected adverse event
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 |
What NCT06923488 shows while recruiting
NCT06923488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06923488's enrollment target sits among peer trials
26 127th of 173 higher than 46 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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.
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