Study on Extended Access to Momelotinib for Patients with 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 bone marrow disorder. The study includes patients with primary myelofibrosis as well as those who have developed myelofibrosis after having other conditions like polycythemia vera or essential thrombocythemia. The treatment being tested in this study is a medication called momelotinib dihydrochloride monohydrate, which is taken in the form of a tablet.

The purpose of this study is to provide extended access to momelotinib and to assess its long-term safety for patients who are already receiving this treatment and have not experienced a worsening of their disease. Participants in the study will continue to take the medication as they have been, and their health will be monitored over time to ensure the treatment remains safe and effective.

Throughout the study, researchers will keep track of any side effects that occur, as well as how serious they are and whether they are related to the medication. They will also look at how long patients live without their disease getting worse and whether they remain free from developing leukemia. This information will help determine the long-term safety and benefits of using momelotinib for treating myelofibrosis.

1 joining the study

Participation begins after enrollment in one of the specified studies: GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301.

Eligibility requires the ability to understand and sign the informed consent form.

2 medication administration

The medication used in this study is momelotinib dihydrochloride monohydrate, administered in the form of a tablet.

The route of administration is oral use.

3 treatment duration

The study provides extended access to the medication for subjects who have not experienced disease progression.

The estimated end date for the trial is December 31, 2026.

4 safety monitoring

The primary focus is on safety, monitoring the incidence, severity, and seriousness of any adverse effects.

Adverse effects are assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.

5 efficacy assessment

Secondary assessments include measuring overall survival and leukemia-free survival.

Who Can Join the Study?

  • Must be currently enrolled in one of the following studies: GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301.
  • Must be able to understand and willing to sign the informed consent form. This means you agree to participate in the study after understanding what it involves.
  • Both men and women can participate.
  • Participants can be from vulnerable populations, which means groups that might need special protection or care.

Who Cannot Join the Study?

  • Patients who have experienced a progression of disease. This means that their condition has gotten worse.
  • Patients who are not currently receiving treatment with MMB (momelotinib), which is a specific medication used in the study.
  • Patients who are not part of the specific studies mentioned (GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, SRA-MMB-301) related to Primary Myelofibrosis or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis. These are specific types of blood disorders.

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
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Spitalul Clinic Coltea Bucharest Romania
Groupe D’Etude Des Lymphomes De L’Adulte Pierre Benite France
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Aalborg University Hospital Aalborg Denmark
Gasthuiszusters Antwerpen Antwerp Belgium
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Onco Card S.R.L. Brasov Romania
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
IRCCS CROB Rionero In Vulture Italy
Specialized Hospital For Active Treatment Of Hematological Diseases EAD Sofia Bulgaria
Ueetujgjjp Dftux Sbzrb Du Rtkq Lh Swhiqhkq Rome Italy
Snwmbbe Wwfhllfqwv W Onqkv Snp z ozdv Opole Poland
Wwryowbjyjfubrgxzffn Sgyfeyr Mynqbjj Itd Jkwumi Shhfddx Z Zilansqh Omzpdudomn Lbdxwsmrtno Sifibvowzmw Plgsfqcfj Zowomk Ocoblu Zfnhpmulrs Z Sczrmtpv W Ppdkjlqb Phpq Ucc Sqvdsramujckg 3 Poznan Poland
Sppvvpzp Chyqjt Myawotcci Fggifftjyxm Clvigli Craiova Romania
Aztqibh Okadvusplmi Umkryflvuqjhg Ctwnztwytwbr Dskoq Szgvdu E Duvhs Sddgccg De Tjigcj Turin Italy
Ulnmadilwhbujc Cdgbqbl Kjfphaddc Gdansk Poland
Hztulqeg Uvewxrnmwbbnq Hlhlmekv Tcznd y Ppcyqz Igjosoze Cdjbhf dxmlhvjhodqlrwswv (bxcg Badalona Spain
Hixubbcy Vczf dgtezire Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.03.2018
Bulgaria Bulgaria
Not recruiting
01.03.2018
Denmark Denmark
Not recruiting
01.03.2018
France France
Not recruiting
01.03.2018
Germany Germany
Not recruiting
01.03.2018
Hungary Hungary
Not recruiting
01.03.2018
Italy Italy
Not recruiting
01.03.2018
Poland Poland
Not recruiting
01.03.2018
Romania Romania
Not recruiting
01.03.2018
Spain Spain
Not recruiting
01.03.2018

Trial locations

Momelotinib is a medication being studied for its potential to help people with a type of bone marrow disorder called myelofibrosis. This condition can occur on its own or after other blood disorders like polycythemia vera or essential thrombocythemia. The trial aims to provide extended access to this medication for patients who are already receiving it and to monitor its long-term safety.

Investigated diseases:

Primary Myelofibrosis – A rare bone marrow disorder where the marrow is replaced by fibrous tissue, leading to severe anemia, weakness, and fatigue. Over time, the spleen and liver may enlarge due to the body’s attempt to produce blood cells outside the bone marrow. Patients often experience symptoms like night sweats, fever, and weight loss. The disease progresses slowly, but the fibrous tissue can eventually lead to bone marrow failure. Blood cell production becomes increasingly impaired, causing complications related to low blood counts.

Post-polycythemia Vera Myelofibrosis – This condition arises as a progression from polycythemia vera, a disorder where the body produces too many red blood cells. Over time, the bone marrow becomes fibrotic, leading to symptoms similar to primary myelofibrosis, such as anemia and an enlarged spleen. Patients may experience fatigue, night sweats, and weight loss. The disease progression involves increasing difficulty in producing blood cells, leading to various complications. The fibrotic transformation can cause significant changes in blood cell counts and function.

Post-essential Thrombocythemia Myelofibrosis – This disease develops from essential thrombocythemia, a condition characterized by excessive platelet production. As the disease progresses, the bone marrow becomes fibrotic, resulting in symptoms like anemia, fatigue, and an enlarged spleen. Patients may also experience night sweats and weight loss. The progression involves a gradual decline in the bone marrow’s ability to produce blood cells effectively. This leads to complications associated with low blood counts and impaired blood cell function.

Trial ID:
2023-508018-41-00
Protocol code:
SRA-MMB-4365/219627
NCT ID:
NCT03441113
Trial Phase:
Therapeutic exploratory (Phase II)

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