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Study of decitabine and cedazuridine combination in patients with lower-risk myelodysplastic syndromes

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with Myelodysplastic Syndromes (MDS), a group of blood disorders where the bone marrow does not produce enough healthy blood cells. The study will test a medication called ASTX727, which contains two active substances: decitabine and cedazuridine. These are given as tablets that are taken by mouth.

The purpose of this study is to evaluate different doses and schedules of ASTX727 in people with lower-risk MDS. The study is divided into two phases. The first phase will determine the safety of different doses and schedules, while the second phase will assess how well the selected doses work in treating the disease.

During the study, participants will take ASTX727 tablets according to a specified schedule. The treatment period may last up to 84 days, during which doctors will monitor the participants' blood counts and overall health. The study will look at how the medication affects blood cell production and whether it helps reduce the need for blood transfusions. Researchers will also track how the body processes the medication and observe any side effects that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility for the study will be evaluated based on specific medical criteria, including blood test results from the past 8 weeks.

    A medical examination will check your liver and kidney function through blood tests.

    If you are of childbearing age, a pregnancy test will be performed.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive ASTX727 treatment, which contains two medicines: decitabine and cedazuridine.

    The medication will be provided in tablet form for oral use.

  3. Step 3

    Treatment period

    You will take the medication according to the prescribed schedule.

    Regular blood tests will monitor your response to treatment.

    Your bone marrow function will be evaluated periodically.

    The study team will monitor and record any side effects you may experience.

  4. Step 4

    Follow-up assessments

    Your blood cell counts will be regularly checked to measure treatment effectiveness.

    The medical team will assess your need for blood transfusions during the study.

    Bone marrow examinations will be performed to monitor disease status.

  5. Step 5

    Study completion

    The study is expected to continue until October 2025.

    Your participation may end earlier based on your response to treatment or other medical factors.

    After completing treatment, you will need to use effective birth control for 3 months (males) or 6 months (females).

Who can join the trial?

16 criteria

  • Must be able to understand the study procedures, risks, and provide informed consent
  • Must be aged 18 years or older with low or intermediate-1 risk MDS and have at least one of these conditions in the past 8 weeks:
    • Need for 2 or more red blood cell transfusions
    • Hemoglobin level of 9.0 g/dL or lower in at least 2 blood tests
    • Low white blood cell count (neutrophils below 0.5×10^9/L) in at least 2 blood tests
    • Low platelet count (below 50×10^9/L) in at least 2 blood tests
    • Must have an ECOG performance status between 0-2 (ability to perform daily activities)
    • Must have adequate liver function:
      • Bilirubin levels no more than 2 times above normal
      • Liver enzymes (AST and ALT) no more than 5 times above normal
      • Must have adequate kidney function:
        • Creatinine levels no more than 1.5 times above normal
        • Kidney filtration rate of at least 50 mL/min
        • Women who can become pregnant must:
          • Not be pregnant or breastfeeding
          • Have a negative pregnancy test
          • Use effective birth control during the study and for 6 months after
          • Men with partners who can become pregnant must:
            • Use condoms during the study
            • Have their partners use effective birth control
            • Agree not to father a child during treatment and for 3 months after

Who cannot join the trial?

15 criteria

  • Prior treatment with hypomethylating agents (drugs that affect DNA methylation)
  • Active or uncontrolled systemic infections requiring treatment
  • Severe heart conditions including uncontrolled high blood pressure, heart failure, or recent heart attack
  • Severe kidney dysfunction requiring dialysis
  • Severe liver dysfunction or active liver disease
  • Known HIV infection
  • Active hepatitis B or C infection
  • Other active cancers requiring treatment
  • Pregnant or breastfeeding women
  • Unable to swallow oral medications
  • Participation in other clinical trials within 30 days
  • Known allergies to the study medication or its components
  • Mental conditions that could interfere with study compliance
  • Life expectancy less than 3 months
  • Blood disorders not related to MDS that could affect study results
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Investigated drugs

ASTX727 is an oral medication being studied for the treatment of myelodysplastic syndromes (MDS), a group of blood disorders. It is designed to work by helping to correct abnormal blood cell production in the bone marrow. This medication is being tested specifically in patients with lower-risk MDS, where it may help improve blood cell counts and reduce the need for blood transfusions.

What is already known about the treatment

ASTX727 – An investigational oral medication being studied in clinical trials for the treatment of Myelodysplastic Syndromes (MDS), specifically in patients with lower-risk disease. This drug is administered orally and represents a novel approach to treating MDS compared to traditional injectable treatments. ASTX727 is currently undergoing Phase 1-2 clinical trials to evaluate its safety profile and determine optimal dosing schedules, with particular focus on a low-dose extended schedule protocol. The medication belongs to the class of drugs that affect blood cell production in bone marrow, though its exact molecular mechanism of action needs further research to be fully understood.

Investigated diseases

Myelodysplastic Syndromes (MDS) - A group of blood disorders where the bone marrow does not produce enough healthy blood cells. In MDS, immature blood cells (blasts) fail to develop properly and often die in the bone marrow. This condition affects the production of red blood cells, white blood cells, and platelets. The abnormal blood cells can gradually fill up the bone marrow, leading to decreased production of normal blood cells. MDS can develop gradually over time, and symptoms may include fatigue, frequent infections, and easy bruising or bleeding. The condition primarily affects older adults, though it can occur at any age.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516296-32-00Protocol codeASTX727-03Estimated enrolment55 patientsSponsorTaiho Oncology Inc.

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