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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

Patients with a condition called Myelofibrosis cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
University Hospital Jena KöR	Jena	Germany
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
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 Nimes	Nimes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Umuihwtlquujcuwdkmqaq Egsvh Avh	Essen	Germany
Issrftqt Rsljlqfkx Pud Lp Sejfmo Dse Tgfyhv Dyfe Amdxkko Ixvw Sdqfoe	Meldola	Italy
Asriihjtcp Pamsaegp Hygxwrqd Dg Pgzwr	Paris	France
Aoiviwq Ucwgh Sioatzxsk Lcoeul Dy Bgnpiik	Bologna	Italy
Ukopsexmey Dmlvs Swdlc Du Rbos Lb Sliiyobe	Rome	Italy
Ijlsesrv Ckuhnj Dvxfalmdkrsfhmnjs	L'hospitalet De Llobregat	Spain
Crcair Hxbjomrlgjk Rwzqszxg Dizgsgscobjgin	Angers	France
Hxvqokiz Vmyw dazhtjfv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	14.02.2025
Germany	Not yet recruiting	14.02.2025
Italy	Not yet recruiting	14.02.2025
Spain	Not yet recruiting	14.02.2025

Trial locations

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.

Investigated diseases:

Primary myelofibrosis

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 ID:

2024-518225-15-00

Protocol code:

220752

NCT ID:

NCT06517875

Trial Phase:

Therapeutic exploratory (Phase II)

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

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