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Study of Momelotinib and Luspatercept for Patients with Transfusion-Dependent Myelofibrosis

Verified siteRegistered drugNo 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 is focused on studying a condition called Myelofibrosis, which is a type of blood cancer that affects the bone marrow. The study will explore the effects of a combination treatment using two medications: Momelotinib and Luspatercept. Momelotinib is taken orally in the form of a tablet, while Luspatercept is administered as a solution for injection under the skin. The purpose of the study is to assess how well this combination can help patients who are dependent on blood transfusions due to their condition.

Participants in the study will receive the combination treatment over a period of up to 24 weeks. During this time, researchers will monitor the participants to see if they can achieve a transfusion independence (TI) response, meaning they do not need blood transfusions for a certain period. The study will also track any side effects or changes in health that may occur during the treatment. The goal is to understand if this combination can improve the quality of life for those with transfusion-dependent Myelofibrosis.

The study is open-label, which means both the participants and the researchers know which treatments are being administered. This trial aims to provide valuable insights into the potential benefits of using Momelotinib and Luspatercept together for managing Myelofibrosis and reducing the need for blood transfusions. The findings from this study could help in developing better treatment strategies for patients with this condition.

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

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history, current health status, and ensuring all criteria are met.

    A pregnancy test is required for women of childbearing potential to ensure they are not pregnant before starting the study.

  2. Step 2

    Start of treatment

    The treatment involves taking two medications: momelotinib and luspatercept.

    Momelotinib is taken orally in the form of a tablet. The specific dosage and frequency will be provided by the study team.

    Luspatercept is administered as a subcutaneous injection, which means it is injected under the skin. The dosage and frequency will also be provided by the study team.

  3. Step 3

    Regular monitoring

    Throughout the study, regular monitoring is conducted to assess health status and response to treatment.

    This includes blood tests to check hemoglobin levels and other important health indicators.

    Participants are monitored for any side effects or adverse events, and adjustments to treatment may be made if necessary.

  4. Step 4

    Evaluation of treatment response

    The main goal is to assess the effect of the treatment on transfusion independence by week 24.

    Transfusion independence means not needing a red blood cell transfusion for a period of 12 weeks, except in cases of significant bleeding.

  5. Step 5

    End of study participation

    At the end of the study, a final assessment is conducted to evaluate overall health and the effects of the treatment.

    Participants will receive guidance on next steps and any necessary follow-up care.

Who can join the trial?

11 criteria

  • Must be at least 18 years old or the legal age of consent in the area where the study is conducted.
  • Must have a confirmed diagnosis of Primary Myelofibrosis (PMF) or Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) according to specific medical criteria.
  • Must be either new to JAK inhibitor treatment or have been treated with certain medications like ruxolitinib or fedratinib for at least 90 days, or 28 days if there were complications requiring blood transfusions or severe side effects like low platelet count, anemia, or bruising.
  • Must be classified as high risk, intermediate-2, or intermediate-1 risk according to specific scoring systems (DIPSS or DIPSS-plus).
  • Must need regular red blood cell (RBC) transfusions or have low hemoglobin levels in the 8 weeks before starting the study treatment. Transfusions due to bleeding or injury are not counted.
  • Must not have a planned allogeneic stem cell transplant (a procedure where a person receives blood-forming stem cells from a donor).
  • Must have a life expectancy of more than 24 weeks.
  • Female participants must not be pregnant or breastfeeding and must use a highly effective method of birth control if they are of childbearing potential. They must also have a negative pregnancy test before starting the study and monthly during the study.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, which is a scale used to assess how a disease affects a patient's daily living abilities.
  • Must have adequate organ function.
  • Must be able to give informed consent and agree to follow the study requirements.

Who cannot join the trial?

1 criterion

  • Patients with a condition called Myelofibrosis cannot participate.
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Investigated drugs

  • Momelotinib

    is a medication being studied for its potential to help people with a condition called myelofibrosis, which affects the bone marrow and can lead to severe anemia. This medication works by targeting specific pathways in the body that are involved in the production of blood cells. By doing so, it may help improve the symptoms of myelofibrosis and reduce the need for blood transfusions.

  • Luspatercept

    is another medication being tested in this study. It is designed to help the body produce more red blood cells, which are crucial for carrying oxygen throughout the body. People with myelofibrosis often have low levels of red blood cells, leading to fatigue and other health issues. Luspatercept aims to increase red blood cell production, potentially reducing the need for regular blood transfusions and improving overall quality of life for patients with this condition.

What is already known about the treatment

  • Momelotinib

    Momelotinib is taken orally in the form of a tablet and is currently being studied in clinical trials for its potential use in treating myelofibrosis, a type of bone marrow cancer. It is not yet widely used in standard medical practice, as research is ongoing to determine its effectiveness and safety. The medication works by blocking certain enzymes in the body that contribute to the growth of cancer cells, helping to reduce symptoms and improve quality of life. It is classified as a Janus kinase (JAK) inhibitor, which is a type of drug that interferes with specific pathways involved in inflammation and cell growth.

  • Luspatercept

    Luspatercept is administered through an injection under the skin and is being explored in clinical trials for its use in treating myelofibrosis, particularly in patients who require regular blood transfusions. While it is approved for other conditions, its role in myelofibrosis is still under investigation. Luspatercept works by helping the body produce more red blood cells, which can reduce the need for transfusions and improve anemia symptoms. It belongs to a class of medications known as erythroid maturation agents, which support the development of red blood cells in the bone marrow.

Investigated diseases

Myelofibrosis – Myelofibrosis is a rare bone marrow disorder characterized by the replacement of bone marrow with fibrous tissue. This process disrupts the body's ability to produce blood cells, leading to anemia, weakness, and fatigue. As the disease progresses, the spleen and liver may enlarge due to the increased workload of producing blood cells. Patients may experience symptoms such as night sweats, fever, and bone pain. Over time, myelofibrosis can lead to severe anemia and other complications related to blood cell production. The disease can also cause a significant reduction in the quality of life due to its chronic nature and associated symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518225-15-00Protocol code220752Estimated enrolment73 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

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