Study Comparing Bomedemstat and Hydroxycarbamide for Patients with Essential Thrombocythemia

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What is this study about?

This clinical trial is focused on studying a condition called Essential Thrombocythemia, which is a type of blood disorder where the body produces too many platelets. Platelets are small blood cells that help with clotting, and having too many can lead to problems like blood clots or bleeding. The study is comparing two treatments: Bomedemstat, also known by its code name MK-3543, and Hydroxycarbamide, which is also known as Hydroxyurea. These medications are being tested to see how effective and safe they are for people who have not received any previous treatment to reduce their platelet count.

The purpose of the study is to compare the effectiveness of Bomedemstat to Hydroxycarbamide in managing Essential Thrombocythemia. Participants in the study will be randomly assigned to receive either Bomedemstat, Hydroxycarbamide, or a placebo. The study will last for a period of up to 36 months, during which participants will take the medication orally in the form of capsules. Throughout the study, participants will be monitored regularly to assess their response to the treatment and to check for any side effects.

This trial aims to provide valuable information on which treatment might be more beneficial for managing Essential Thrombocythemia. By participating, individuals contribute to research that could improve future treatment options for this condition. The study is designed to ensure the safety and well-being of all participants, with regular check-ups and assessments conducted by healthcare professionals.

1 joining the study

Upon joining the study, the participant is confirmed to have a diagnosis of essential thrombocythemia based on specific criteria. The participant must not have received any prior treatment for this condition.

2 randomization

The participant is randomly assigned to receive either bomedemstat (MK-3543) or hydroxyurea. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

3 treatment administration

The participant takes the assigned medication orally in the form of a hard capsule. The specific dosage and frequency are determined by the study protocol and are followed throughout the trial.

4 monitoring and assessments

Regular monitoring is conducted to assess the participant’s response to the treatment. This includes evaluating the durable clinicohematologic response and other health indicators.

Participants are also assessed for any changes in symptoms and overall health status using specific forms and questionnaires.

5 completion of the study

The study is estimated to conclude by May 14, 2029. Upon completion, the participant’s overall health and response to the treatment are thoroughly evaluated.

Who Can Join the Study?

  • Must have a diagnosis of Essential Thrombocythemia (ET), which is a condition where the body makes too many blood cells called platelets, based on specific medical guidelines.
  • Must have a bone marrow fibrosis score of Grade 0 or Grade 1. This means the bone marrow, where blood cells are made, is in a healthy or slightly affected state.
  • Must not have received any previous treatment aimed at reducing blood cell production for their ET.
  • If the participant has HIV (a virus that affects the immune system), it must be well controlled with medication.
  • If the participant has tested positive for Hepatitis B (a liver infection), they must have been on treatment for at least 4 weeks and have no detectable virus in their blood.
  • If the participant has a history of Hepatitis C (another liver infection), the virus must not be detectable in their blood.
  • Both male and female participants are eligible to join the study.

Who Cannot Join the Study?

  • Patients with medical conditions other than Essential thrombocythemia cannot participate. Essential thrombocythemia is a condition where the body produces too many blood platelets, which are cells that help with blood clotting.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may have a higher risk of harm or exploitation.

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
Region Oerebro Laen Orebro Sweden
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Universitario 12 De Octubre Madrid Spain
Pratia Hematologia Sp. z o.o. Katowice Poland
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Odense University Hospital Odense Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Hospital Clinic De Barcelona Barcelona Spain
Karolinska University Hospital Solna Sweden
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Centre Hospitalier Universitaire De Nice Nice France
Dr. Vehling-Kaiser MVZ GmbH Landshut Germany
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
University Of Szeged Szeged Hungary
Hospital Costa del Sol Marbella Spain
Region Sjaelland Holbæk Denmark
Upmvcveufrnixyxjmqjmd Eyfty Aep Essen Germany
Oblprqaughiyxs Lgmc Gndh Linz Austria
Mtyunucbieguowcmxgynjjrsea Hxnzhncputnfpycr Halle (Saale) Germany
Hcpknvfp Urbyulsqovhns Mptmlck Dp Vusaadeyki Santander Spain
Itpyikho Ccszhz Dbvllwquhzutqwvna L'hospitalet De Llobregat Spain
Iisqadblw Dw Iwcchpsffprtr Ek Cdoflipz Dh Lh Sxwgi Ggonvin Tyibq I Psebk Barcelona Spain
Abtlgmjzzy Pihdkzvx Hybrspos Dt Pfdkl Paris France
Aqjlxtaxqh Pzudsyxo Hhvylfqy Dd Mgeckuocr Marseille France
Ualbqoj Unoawxstko Hdlorsht Uppsala Sweden
Cbcpfh Hsmcvmfowrz Rnozwubm Ugzwqdvfanbjv Dm Tlmbj Tours France
Gepsaywhwsyflvska Vqjhxgqdt Pjnb Acxwra Eimfomku Opprkw Kxycif Gyor Hungary
Afdpdkb Ohcjjhrzsei Nwgpbwivw Sj Ayutdky E Bkfzse E C Apvzvl Akrofmkkdfu Alexandria Italy
Ajzqrqi Uqroo Siwiiaavu Lxthmd Dg Bhcnuoh Bologna Italy
Hpiuqwvy Vzua dikmvwxm Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
07.10.2024
Denmark Denmark
Recruiting
07.10.2024
France France
Recruiting
07.10.2024
Germany Germany
Recruiting
07.10.2024
Hungary Hungary
Recruiting
07.10.2024
Italy Italy
Recruiting
07.10.2024
Poland Poland
Recruiting
07.10.2024
Spain Spain
Recruiting
07.10.2024
Sweden Sweden
Recruiting
07.10.2024

Trial locations

Bomedemstat (MK-3543) is a medication being studied for its effectiveness and safety in treating essential thrombocythemia, a condition characterized by an overproduction of platelets in the blood. This medication is being compared to another treatment to see how well it works in managing the disease.

Hydroxyurea is a medication commonly used to treat essential thrombocythemia. It helps to reduce the number of platelets in the blood, which can help prevent complications associated with the condition. In this study, it serves as a comparison to evaluate the effectiveness of bomedemstat.

Essential thrombocythemia – This is a chronic blood disorder characterized by the overproduction of platelets by the bone marrow. It often progresses slowly and may not cause symptoms initially. Over time, individuals may experience headaches, dizziness, or vision changes due to increased blood viscosity. Some people may also develop blood clots or bleeding issues. The condition can lead to complications such as an enlarged spleen or changes in blood cell counts. It is considered a type of myeloproliferative neoplasm, which involves the abnormal growth of blood cell precursors.

Trial ID:
2023-505232-36-00
Protocol code:
MK-3543-007
Trial Phase:
Therapeutic confirmatory (Phase III)

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