Recruiting

Bomedemstat for Essential Thrombocythemia with Hydroxyurea Intolerance

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What is being tested

Bomedemstat

+ Anagrelide

+ Busulfan

Drug
Who is being recruted

Blood Coagulation Disorders+6

+ Blood Platelet Disorders

+ Bone Marrow Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2023
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 31, 2023

Actual date on which the first participant was enrolled.

The study aims to compare the safety and effectiveness of a new treatment called bomedemstat with the current best available therapies for individuals with essential thrombocythemia (ET). ET is a condition characterized by the overproduction of platelets, which can lead to complications like blood clots. This study focuses on those who do not respond well to or cannot tolerate the standard treatment, hydroxyurea. The goal is to determine if bomedemstat provides a better and more lasting improvement in managing the condition, potentially offering a new option for patients who struggle with current treatments. Participants in the study will receive either bomedemstat or one of the best available therapies, as determined by their healthcare provider. The treatment effects are closely monitored to evaluate the overall improvements in blood cell levels and other health indicators. The study's primary focus is on achieving a durable clinicohematologic response, meaning a stable and sustained improvement in the participants' condition. This approach helps ensure that the new treatment is not only effective but also safe for long-term use. As the study progresses, both the benefits and any side effects of the treatment will be carefully assessed.

Official TitleA Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543/IMG-7289) Versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia Who Have an Inadequate Response to or Are Intolerant of Hydroxyurea
NCT06079879
Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

340 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Coagulation DisordersBlood Platelet DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersMyeloproliferative DisordersThrombocythemia, EssentialThrombocytosis

Criteria

7 inclusion criteria required to participate
Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist)
Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance
Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
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5 exclusion criteria prevent from participating
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
Evidence at the time of Screening of increased risk of bleeding
History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will begin treatment at a dose of 50 mg of bomedemstat daily. Dosage will be adjusted either up or down within specified time parameters for each participant to the dose that provides sufficient exposure to safely inhibit thrombopoiesis to decrease platelet counts to the target range. All participants will be treated daily for up to 52 weeks, and are eligible for an extended treatment phase up to 156 weeks.

Group II

Active Comparator
Each participant will receive either anagrelide, busulfan, interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b, or ruxolitinib as determined by investigator. All participants will be treated per respective approved product labels for up to 52 weeks. Participants receiving BAT for 52 weeks who stop responding to BAT are eligible to switch to bomedemstat and receive this for up to 156 weeks at the investigators discretion.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 161 locations

Recruiting

Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496)

Glendale, United StatesOpen Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496) in Google Maps
Recruiting

Los Angeles Cancer Network ( Site 3491)

Glendale, United States
Recruiting

Stanford Cancer Institute ( Site 0107)

Stanford, United States
Recruiting

The Lundquist Institute ( Site 3423)

Torrance, United States
Recruiting
161 Study Centers