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Leflunomide and Decitabine for Relapsed or Refractory Myelodysplastic Syndromes

This study is testing a combination of two drugs, leflunomide and decitabine, for adults with myelodysplastic syndromes (MDS) that have come back or haven't responded to previous treatment. MDS is a type of cancer where the bone marrow doesn't make enough healthy blood cells. Researchers want to see how safe this drug combination is and what doses can be given without causing too many side effects. You might be able to join if you have a confirmed diagnosis of MDS, have certain blood count levels, and have had one prior treatment. The study aims to find the highest safe dose of this combination. The study is currently unclear on its recruitment status and plans to enroll 26 participants.

Study design
This is a dose-escalation study (meaning drug doses will be gradually increased) to evaluate the safety and effectiveness of leflunomide and decitabine. It plans to enroll 26 adult participants.
What's involved
You will receive decitabine intravenously (through a vein) for 5 days every 4 weeks, and take leflunomide by mouth daily for 14 to 21 days within each 28-day cycle. Bone marrow biopsies and blood tests will be done at specific times throughout the study and at the end.
Compensation
Not stated in the trial record.
Follow-up
The study will determine side effects from the first day of treatment up to 13 months. Responding patients can continue treatment after 12 cycles.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06923488

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
West Virginia University
~26 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Leflunomide 10mgLeflunomide 20mgDecitabine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of incidences of regimen limiting toxicities (RLTs)
Measured over Date of first treatment up to 13 months

Conditions

Myelodysplastic Syndromes

Explore related trials

Myelodysplastic Syndrome

Where it's being run

1 sites across 1 states
West Virginia1

Study leadership

  • Konstantinos Sdrimas, MD · PRINCIPAL_INVESTIGATOR · West Virginia University

Who to contact

Konstantinos Sdrimas, MD
[email protected]
304-598-4520
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient has pathologically confirmed diagnosis of MDS
Patient has currently measurable disease meeting the following criteria:
Bone marrow biopsy with more than 5% blasts, AND
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
Patient has received one prior treatment with a DNA methyltransferase inhibitor (DNMTi), also commonly called hypomethylating agent (HMA). Patients whose MDS has IDH1/IDH2 mutations should have received at least one available IDH1/IDH2 inhibitor
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Patient has the following required baseline laboratory data (eligibility can be based on local lab results):
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
Patients who have undergone alloHSCT are eligible if they are more than 28 days post stem cell infusion, have no evidence of GVHD \> Grade 1, and are more than a week off all immunosuppressive therapy
If a female of childbearing potential, the patient has a negative serum or urine pregnancy test result within 7 days prior to the first dose of treatment. Women of non-childbearing potential are those who are postmenopausal greater than one year or who have had a bilateral tubal ligation or hysterectomy
If female of childbearing potential or a male patient, patient agrees to use an effective contraceptive method from the time of informed consent, during the course of the study, and for 3 months following the last dose of treatment
Patient understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution

Exclusion

Patients receiving any other investigational agents, or concurrent chemotherapy or immunotherapy
Patients with progression to acute myeloid leukemia
Patients with other malignancies requiring systemic chemotherapy, immunotherapy or targeted therapy in the last four weeks
Patients with uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms)
Patients with active or latent tuberculosis
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that per Principal Investigator's judgment would limit compliance with study requirements
Females who are pregnant or breast feeding
Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study

What this trial measures

  • Percentage of incidences of regimen limiting toxicities (RLTs)Date of first treatment up to 13 months

    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