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

2 1 1

What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Mtz Clinical Research Powered By Pratia Warsaw Poland
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Pratia Hematologia Sp. z o.o. Katowice Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Nice Nice France
Wojewodzki Szpital Specjalistyczny W Legnicy Legnica Poland
Hopital Beaujon Clichy France
Hospital Universitario Virgen De La Victoria Malaga Spain
Iedwcggs Cuugly Dshrfjvfyfvqtsjnn L'hospitalet De Llobregat Spain
Urpplvxxzqoardkusjpob Mpzetlhw Abf Munster Germany
Hgeivajv Vyux dbvyuctf Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
24.06.2025
Germany Germany
Recruiting
24.06.2025
Italy Italy
Recruiting
24.06.2025
Poland Poland
Recruiting
24.06.2025
Spain Spain
Recruiting
24.06.2025

Trial locations

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.

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 ID:
2024-519928-24-00
Protocol code:
223584
NCT ID:
NCT06847867
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Phase 1/2 Study of LB-208 in Adults with Relapsed or Refractory Acute Myeloid Leukaemia and High‑Risk Myelodysplastic Syndrome

    Recruiting

    1 1 1
    Spain
  • Study of venetoclax, treosulfan and fludarabine before stem cell transplant in patients with acute myeloid leukemia and myelodysplastic syndrome

    Recruiting

    2 1 1 1
    Germany