Actively Recruiting
Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes
Led by West Virginia University · Updated on 2026-04-23
26
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has pathologically confirmed diagnosis of MDS
- Patient has currently measurable disease with bone marrow blasts more than 5% and low neutrophils, platelets, or hemoglobin
- Patient has received one prior treatment with a DNA methyltransferase inhibitor or hypomethylating agent; patients with IDH1/IDH2 mutations should have received at least one IDH1/IDH2 inhibitor
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Baseline labs with total serum bilirubin less than or equal to 2 times the upper limit of normal
- Estimated glomerular filtration rate (eGFR) of at least 45 mL/min/1.73 m2
- Patients post allogeneic stem cell transplant are eligible if more than 28 days from infusion, no graft-versus-host disease above Grade 1, and more than one week off immunosuppressive therapy
- Negative pregnancy test within 7 days prior to first treatment for females of childbearing potential
- Women of non-childbearing potential are postmenopausal for more than one year or have had bilateral tubal ligation or hysterectomy
- Agreement to use effective contraception during the study and for 3 months after treatment if of childbearing potential
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Receiving any other investigational agents, chemotherapy, or immunotherapy concurrently
- Progression to acute myeloid leukemia
- Other cancers requiring systemic chemotherapy, immunotherapy, or targeted therapy within the last 4 weeks
- Uncontrolled bacterial, viral, or fungal infections
- Active or latent tuberculosis
- Uncontrolled illness such as symptomatic heart failure, unstable angina, arrhythmia, psychiatric illness, or social situations limiting compliance
- Pregnant or breastfeeding females
- Any clinical condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
West Virginia University Cancer Institute
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
K
Konstantinos Sdrimas, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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