Study on Leflunomide and Decitabine for Treating Relapsed or Hard-to-Treat Myelodysplastic Syndromes

Sponsor: West Virginia University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06923488

Provider View

This clinical trial is testing a combination of two drugs, leflunomide and decitabine, to see if they are safe and effective for patients with myelodysplastic syndromes (MDS) that have returned or are difficult to treat.

Patient Parameters

Program Overview

The purpose of this study is to find out if using leflunomide together with decitabine can be a safe and effective treatment for patients with myelodysplastic syndromes (MDS) that have come back or are not responding to other treatments. The study will determine the best doses of these drugs when used together. Decitabine is given through an IV for five days in a row every four weeks, while leflunomide is taken as a pill once a day for 14 to 21 days in a 28-day cycle. Patients who respond well can continue the treatment after 12 cycles.

Description

This study is in two phases (Phase I/II) and aims to find the best dose of leflunomide when used with decitabine for treating relapsed or hard-to-treat myelodysplastic syndromes (MDS). Patients will take leflunomide by mouth daily and receive decitabine through an IV for five days in a 28-day cycle. The study will test different doses to ensure the combination is safe and well-tolerated. If any serious side effects occur, the doctor may adjust the treatment. Patients will have regular check-ups, including bone marrow tests and blood counts, to monitor their progress. After 12 cycles, patients who are doing well can continue the treatment. The study will also track any side effects using a standard grading system.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with myelodysplastic syndromes (MDS).
  • Have measurable disease with more than 5% blasts in bone marrow, low neutrophil or platelet counts, or low hemoglobin levels.
  • Previously treated with a DNA methyltransferase inhibitor (DNMTi) or hypomethylating agent (HMA). If MDS has IDH1/IDH2 mutations, must have tried an IDH1/IDH2 inhibitor.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Meet specific lab test requirements for liver and kidney function.
  • If previously had a stem cell transplant, must be more than 28 days post-transplant, with no severe graft-versus-host disease, and off immunosuppressive therapy for over a week.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
  • Understand and sign a consent form before starting the study.

Exclusion Criteria

  • Currently taking other experimental drugs or undergoing chemotherapy or immunotherapy.
  • Progressed to acute myeloid leukemia.
  • Have other cancers needing treatment in the last four weeks.
  • Have uncontrolled infections or active tuberculosis.
  • Have serious health issues like heart failure or unstable mental health that could affect participation.
  • Pregnant or breastfeeding women.
  • Any other conditions that the study doctor thinks would make participation unsuitable.

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