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Study of momelotinib tablets in patients with anemia caused by low-risk myelodysplastic syndrome

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What is this trial about?

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

This study focuses on Myelodysplastic Syndrome, a condition where the bone marrow does not produce enough healthy blood cells. The research specifically looks at patients with low-risk form of this disease who have anemia (low red blood cell counts) and require regular blood transfusions. The study will test a new medication called momelotinib, which is given as tablets taken by mouth.

The purpose of this research is to determine if momelotinib can help patients become less dependent on blood transfusions. The study will be conducted in two parts - first to find the right dose of the medication, and then to see how well it works in reducing the need for blood transfusions over a 24-week period.

During the study, participants will receive momelotinib tablets and will be monitored for how their body responds to the treatment. The researchers will track how many blood transfusions patients need and will also check for any side effects of the medication. The total treatment period may last up to 76 weeks, during which patients will have regular check-ups to monitor their health and blood counts.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the study will be evaluated based on specific medical criteria, including confirmation of myelodysplastic syndrome (MDS) diagnosis

    Your medical history and previous treatments with ESA or other approved therapies will be reviewed

    Basic health assessments will be performed to ensure adequate organ function

  2. Step 2

    Treatment initiation

    You will receive momelotinib tablets for oral use

    The medication must be taken according to the prescribed schedule

    Your red blood cell transfusion needs will be monitored throughout the study

  3. Step 3

    24-week monitoring period

    Regular assessments will track your response to the treatment

    Blood tests will be conducted to monitor your condition

    Any side effects or changes in your health will be recorded

    The main goal is to evaluate if you can become independent from red blood cell transfusions for at least 12 weeks

  4. Step 4

    Long-term follow-up

    Continued monitoring of your health status and response to treatment

    Regular evaluation of laboratory test results

    Assessment of any long-term effects of the medication

    The study is expected to continue until October 2028

Who can join the trial?

10 criteria

  • Must be at least 18 years old or of legal age to consent in your area
  • Must have been diagnosed with Myelodysplastic Syndrome (MDS) classified as very low, low, or intermediate risk
  • Must have previously received treatment with ESA (drugs that stimulate red blood cell production) or luspatercept (a medication for anemia) and either did not respond to treatment or lost response over time
  • Must require regular blood transfusions - specifically at least 4 units of red blood cells over an 8-week period in the past 16 weeks
  • For female participants:
    • Must not be pregnant or breastfeeding
    • Must either be unable to have children, or
    • If able to have children, must use highly effective birth control (99% effective) starting 28 days before the study and continuing until 1 week after the last dose
    • Must be able to understand and sign the informed consent form
    • Must have an ECOG performance status of 2 or better (meaning able to carry out most daily activities)
    • Must have adequate organ function based on medical tests

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Previous treatment with momelotinib (the study medication)
  • Active or chronic infections
  • Significant heart conditions or uncontrolled high blood pressure
  • History of other cancers within the past 3 years (except for successfully treated skin cancer or early-stage cancer)
  • Severe liver problems
  • Severe kidney problems
  • Pregnant or breastfeeding women
  • Unable to swallow oral medications
  • Currently participating in other clinical trials
  • Mental conditions that could interfere with following study procedures
  • Known allergies to similar medications
  • Unstable medical conditions that could affect study participation
  • Major surgery within 4 weeks before starting the study
  • Use of medications that could interact with the study drug
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Investigated drugs

Momelotinib is a medication being studied for treating anemia in patients with low-risk myelodysplastic syndrome. It is designed to help patients who have low red blood cell counts. This medication works by targeting specific proteins involved in blood cell production and may help reduce the need for blood transfusions.

What is already known about the treatment

Momelotinib - An oral medication administered in tablet form that belongs to the class of JAK inhibitors, currently being investigated in clinical trials for the treatment of anemia in patients with low-risk Myelodysplastic Syndrome (MDS). The drug works by selectively blocking JAK1 and JAK2 enzymes, which are involved in blood cell production and inflammatory signaling pathways. This targeted molecular approach aims to improve red blood cell production and reduce transfusion dependency in MDS patients, with the medication showing promising results in Phase 2 clinical trials for managing anemia symptoms.

Investigated diseases

Myelodysplastic Syndrome - A group of blood disorders where the bone marrow doesn't produce enough healthy blood cells. The condition occurs when the blood-forming cells in the bone marrow become abnormal and have problems creating new blood cells. This leads to low numbers of one or more types of blood cells (red blood cells, white blood cells, or platelets). The bone marrow may produce immature cells called blasts that don't develop into normal blood cells. Over time, the abnormal cells can crowd out the healthy blood cells in the bone marrow.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519928-24-00Protocol code223584Estimated enrolment91 patientsSponsorGlaxosmithkline Research & Development Limited

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