OncoMatch/Clinical Trials/NCT06923488
Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes
Is NCT06923488 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Leflunomide 10mg and Leflunomide 20mg for myelodysplastic syndromes.
Treatment: Leflunomide 10mg · Leflunomide 20mg · Decitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Biomarker criteria
Allowed: IDH1 mutation
Allowed: IDH2 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: DNA methyltransferase inhibitor
Patient has received one prior treatment with a DNA methyltransferase inhibitor (DNMTi), also commonly called hypomethylating agent (HMA)
Must have received: IDH1 inhibitor
Patients whose MDS has IDH1/IDH2 mutations should have received at least one available IDH1/IDH2 inhibitor
Must have received: IDH2 inhibitor
Patients whose MDS has IDH1/IDH2 mutations should have received at least one available IDH1/IDH2 inhibitor
Lab requirements
Blood counts
Absolute neutrophil count (ANC) less than 1,000/mcL, and/or platelet count less than 100,000/mcL and/or hemoglobin levels less than 10g/dL
Kidney function
Estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m2
Liver function
Total serum bilirubin level less than or equal to 2 times ULN
Total serum bilirubin level less than or equal to 2 times ULN; Estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m2; Absolute neutrophil count (ANC) less than 1,000/mcL, and/or platelet count less than 100,000/mcL and/or hemoglobin levels less than 10g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- West Virginia University Cancer Institute · Morgantown, West Virginia
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