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RECRUITING
NCT06923488
PHASE1/PHASE2

Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes

Sponsor: West Virginia University

View on ClinicalTrials.gov

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.

Official title: Phase I/II Study of Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2025-08

Completion Date

2028-10

Last Updated

2025-07-20

Healthy Volunteers

No

Interventions

DRUG

Leflunomide 10mg

Leflunomide 10mg tablet

DRUG

Leflunomide 20mg

Leflunomide 20mg tablet

DRUG

Decitabine

Decitabine dose of 20 mg/m2

Locations (1)

West Virginia University Cancer Institute

Morgantown, West Virginia, United States