Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

July 15, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) Versus Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Santa Fe, Argentina, 3000
        • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105)
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, B1629AHJ
        • Hospital Universitario Austral ( Site 0101)
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires ( Site 0102)
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IKO
        • C.I.C.E. 9 de Julio ( Site 0104)
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2115
        • Westmead Hospital ( Site 0201)
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203)
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health-Haematology Research ( Site 0202)
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health-Cancer Clinical Trials Centre ( Site 0206)
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital-Haematology ( Site 0204)
  • Austria
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Ordensklinikum Linz GmbH Elisabethinen ( Site 0562)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0038)
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0037)
  • Chile
    • Biobio
      • Concepción, Biobio, Chile, 4070196
        • Biocenter ( Site 0149)
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chile, 1720430
        • IC La Serena Research ( Site 0150)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • FALP-UIDO ( Site 0148)
      • Santiago, Region M. de Santiago, Chile, 7580206
        • Clínica Inmunocel ( Site 0147)
      • Santiago, Region M. de Santiago, Chile, 7650568
        • Clínica Alemana de Santiago ( Site 0143)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Bradfordhill-Clinical Area ( Site 0142)
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Afflilated Hospital of Bengbu Medical College ( Site 0651)
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital ( Site 0657)
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital-Hematology ( Site 0659)
      • Beijing, Beijing Municipality, China, 100730
        • Chinese Academy of medical science, Peking Union Medical College Hospital(Dongdan) ( Site 0675)
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Chongqing University Cancer Hospital ( Site 0666)
    • Fujian
      • Quanzhou, Fujian, China, 362000
        • The Second Affiliated Hospital of Fujian Medical University ( Site 0671)
      • Xiamen, Fujian, China, 361003
        • The First Affiliated hospital of Xiamen University ( Site 0658)
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University-hematology department ( Site 0668)
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 0655)
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Afilliated Hospital of Hebei Medical University ( Site 0650)
      • Shijiazhuang, Hebei, China, 050031
        • The First Hospital of Hebei Medical University ( Site 0649)
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital-hematology department ( Site 0644)
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0642)
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University ( Site 0676)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330209
        • The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0645)
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University-Hematology ( Site 0672)
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Shaanxi provincial people's hospital ( Site 0652)
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital ( Site 0667)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital,Fudan University-Hematology ( Site 0674)
      • Shanghai, Shanghai Municipality, China, 200040
        • Huashan Hospital, Fudan University ( Site 0669)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University ( Site 0661)
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 301636
        • Institute of hematology&blood disease hospital-Hematology ( Site 0641)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 0646)
      • Yiwu, Zhejiang, China, 322000
        • Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 0662)
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050030
        • Fundacion Colombiana de Cancerología Clinica Vida ( Site 0164)
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110121
        • Los Cobos Medical Center ( Site 0165)
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • IMAT S.A.S ( Site 0162)
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Rigshospitalet-Hematology - CTU ( Site 0321)
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324)
    • Region Sjælland
      • Roskilde, Region Sjælland, Denmark, 4000
        • Roskilde Sygehus-Department of Hematology ( Site 0323)
    • Region Syddanmark
      • Odense C, Region Syddanmark, Denmark, 5000
        • Odense Universitetshospital-Department of Hematology ( Site 0325)
  • France
      • Paris, France, 75010
        • Hopital Saint-Louis ( Site 0341)
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology ( Site 0349)
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • CHU Bordeaux Haut-Leveque-service de mèdecine interne et maladies infectieuses ( Site 0346)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13005
        • Hôpital de la Conception ( Site 0351)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0352)
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87042
        • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0344)
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37000
        • Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0342)
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44093
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0347)
    • Rhone
      • Pierre-Bénite, Rhone, France, 69310
        • centre hospitalier lyon sud ( Site 0343)
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • HENRI MONDOR HOSPITAL ( Site 0348)
  • Germany
      • Berlin, Germany, 13353
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0369)
    • Bavaria
      • Landshut, Bavaria, Germany, 84036
        • VK&K Studien GbR ( Site 0370)
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover ( Site 0371)
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • Universitätsklinikum Aachen ( Site 0367)
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Universitaetsklinikum Essen ( Site 0366)
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Site 0365)
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Universitätsklinikum Halle ( Site 0361)
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Universitätsklinikum Jena-Klinik für Innere Medizin II, Abt. Hämatologie und Internistische Onkolog ( Site 0364)
  • Hong Kong
      • Hksar, Hong Kong
        • Queen Mary Hospital ( Site 0221)
  • Hungary
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6725
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 0407)
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Petz Aladar Egyetemi Oktato Korhaz-Hematológia ( Site 0405)
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Vármegyei Kaposi Mór Oktató Kórház-Haematológiai osztály ( Site 0406)
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0404)
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center ( Site 0427)
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus ( Site 0429)
      • Haifa, Israel, 3436212
        • Carmel Hospital ( Site 0426)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center ( Site 0424)
      • Nahariya, Israel, 2201202
        • Galilee Medical Center ( Site 0431)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 0425)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center ( Site 0428)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center ( Site 0422)
      • Ẕerifin, Israel, 7033001
        • Yitzhak Shamir Medical Center. ( Site 0421)
  • Italy
      • Alessandria, Italy, 15121
        • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0443)
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0446)
      • Milan, Italy, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0447)
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0444)
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0445)
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi Varese ( Site 0442)
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi ( Site 0441)
  • Japan
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital ( Site 0605)
      • Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital ( Site 0616)
      • Miyazaki, Japan, 889-1692
        • University of Miyazaki Hospital ( Site 0609)
      • Okayama, Japan, 700-8558
        • Okayama University Hospital ( Site 0604)
      • Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital ( Site 0608)
    • Aichi-ken
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Fujita Health University Hospital ( Site 0613)
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University Hospital ( Site 0612)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital ( Site 0601)
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Medical Center General Hospital ( Site 0603)
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital ( Site 0614)
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Mie University Hospital ( Site 0615)
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8520
        • National Hospital Organization Sendai Medical Center ( Site 0617)
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital ( Site 0607)
      • Sakai, Osaka, Japan, 590-0197
        • Kindai University Hospital ( Site 0600)
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital ( Site 0611)
    • Yamanashi
      • Chūō, Yamanashi, Japan, 409-3898
        • University of Yamanashi Hospital ( Site 0606)
  • Mexico
    • Chihuahua
      • Chihuahua City, Chihuahua, Mexico, 31203
        • Medivest Centro de Investigación Integral ( Site 0183)
    • Mexico City
      • Mexico City, Mexico City, Mexico, 11819
        • Higiea Oncologia ( Site 0184)
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Centro de Investigacion Clinica de Oaxaca ( Site 0181)
  • Poland
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-081
        • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp ( Site 0463)
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-519
        • Pratia Onkologia Katowice ( Site 0461)
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 0466)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0489)
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre ( Site 0494)
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 0488)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0490)
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Institut Català d'Oncologia - L'Hospitalet ( Site 0482)
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla-Haematology ( Site 0486)
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 0481)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28027
        • Clinica Universidad de Navarra-Hematology Department ( Site 0485)
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramón y Cajal-Hematology ( Site 0484)
    • Malaga
      • Marbella, Malaga, Spain, 29603
        • Hospital Costa del Sol-Hematology Service ( Site 0493)
  • Sweden
    • Skåne County
      • Lund, Skåne County, Sweden, 22185
        • Skånes Universitetssjukhus Lund-Department of Hematology ( Site 0544)
    • Stockholm County
      • Huddinge, Stockholm County, Sweden, 141 86
        • Karolinska Universitetssjukhuset Huddinge ( Site 0541)
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 751 85
        • Akademiska sjukhuset ( Site 0545)
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset-Department of hematology and coagulation ( Site 0543)
    • Örebro County
      • Örebro, Örebro County, Sweden, 701 85
        • Universitetssjukhuset Örebro ( Site 0542)
  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital-Clinical Trial Center ( Site 0245)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 0241)
      • Taoyuan, Taiwan, 33305
        • Chang Gung Medical Foundation-Linkou Branch ( Site 0243)
    • Chiayi
      • Chiayi City, Chiayi, Taiwan, 613
        • Chang Gung Memorial Hospital- Chiayi ( Site 0242)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06200
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-Hemotology ( Site 0510)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universite Hastaneleri-Department of Hematology ( Site 0505)
      • Ankara, Turkey (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0502)
      • Ankara, Turkey (Türkiye), 6620
        • Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 0511)
      • Antalya, Turkey (Türkiye), 07100
        • Antalya Egitim ve Arastırma Hastanesi ( Site 0508)
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University Medical Faculty Hospital-Hematology ( Site 0501)
      • Istanbul, Turkey (Türkiye), 34214
        • Medipol Mega Universite Hastanesi ( Site 0504)
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli Üniversitesi-Hematology ( Site 0506)
      • Samsun, Turkey (Türkiye), 55139
        • Ondokuz Mayıs Universitesi-hematology ( Site 0507)
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Ege Universitesi Hastanesi ( Site 0503)
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital ( Site 0532)
      • Newport, United Kingdom, NP20 2EF
        • Royal Gwent Hospital ( Site 0524)
    • Denbighshire
      • Bodelwyddan, Denbighshire, United Kingdom, LL18 5UJ
        • Glan Clwyd Hospital ( Site 0528)
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, Gl1 3NN
        • Gloucestershire Royal Hospital ( Site 0521)
    • Great Britain
      • Lincoln, Great Britain, United Kingdom, LN2 5QY
        • Lincoln County Hospital ( Site 0535)
    • Lincolnshire
      • Boston, Lincolnshire, United Kingdom, PE21 9QS
        • Boston Pilgrim Hospital ( Site 0525)
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • University College London Hospital ( Site 0527)
      • London, London, City of, United Kingdom, SE1 9RT
        • Guy's & St Thomas' NHS Foundation Trust ( Site 0523)
      • London, London, City of, United Kingdom, W12 OHS
        • Hammersmith Hospital ( Site 0533)
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Palo Verde Cancer Specialists ( Site 0052)
    • California
      • Glendale, California, United States, 91206
        • Los Angeles Cancer Network ( Site 0025)
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Center ( Site 0024)
    • Colorado
      • Golden, Colorado, United States, 80401
        • Exempla Lutheran Medical Center ( Site 0014)
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine ( Site 0051)
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Research Center at Parkview Regional Medical Center ( Site 0006)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan ( Site 0003)
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Optum Care Cancer Center ( Site 0053)
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute ( Site 0009)
      • Durham, North Carolina, United States, 27710
        • Duke University Health System (DUHS) ( Site 0012)
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013)
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center ( Site 0028)
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8005)
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University ( Site 0018)
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • TriStar Bone Marrow ( Site 7000)
    • Texas
      • Amarillo, Texas, United States, 79124
        • Texas Oncology - West Texas ( Site 8003)
      • Dallas, Texas, United States, 75246
        • Texas Oncology - DFW ( Site 8006)
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center ( Site 0026)
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio ( Site 0021)
      • Webster, Texas, United States, 77598
        • Texas Oncology - Gulf Coast ( Site 8008)
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia ( Site 0020)
      • Richmond, Virginia, United States, 23219
        • VCU Health Adult Outpatient Pavillion ( Site 0008)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status
  • 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 received no prior cytoreductive treatment for their ET
  • Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
  • Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

  • History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
  • History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has an active infection requiring systemic therapy
  • Has had a major surgery <4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery >4 weeks prior to first dose

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bomedemstat
Participants will receive active bomedemstat and hydroxyurea placebo daily for up to approximately 52 weeks. 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. Participants who complete treatment at Week 52 will be eligible to continue treatment in the extended treatment phase. Unblinding will occur and placebo discontinued once all participants have completed at least 52 weeks of therapy or otherwise discontinued.
Drug: Bomedemstat
Oral capsule
Other Names:
  • IMG-7289
  • MK-3543
Drug: Hydroxyurea placebo
Oral capsule placebo
Active Comparator: Hydroxyurea
Participants will receive active hydroxyurea and bomedemstat placebo daily for up to 52 weeks. 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. Participants who complete treatment at Week 52 will be eligible to continue treatment in the extended treatment phase. Unblinding will occur and placebo discontinued once all participants have completed at least 52 weeks of therapy or otherwise discontinued.
Drug: Hydroxyurea
Oral capsule
Drug: Bomedemstat placebo
Oral capsule placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Durable Clinicohematologic Response (DCHR) Rate
Time Frame: Up to Week 52
DCHR rate is the percentage of participants with DCHR, defined as a confirmed reduction of platelet count to ≤400 × 10^9/L, absence of white blood cell (WBC) count elevation to >10 × 10^9/L locally assessed to be due to ET, starting by Week 24 and maintained for at least 24 weeks, and the absence of any thrombotic or major hemorrhagic events or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) by Week 52.
Up to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) Individual Fatigue Symptom Item Score
Time Frame: Baseline and pre-specified timepoints up to Week 52
The MFSAF v4.0 is a 7-item participant-reported myelofibrosis symptom assessment which asks respondents to report symptom severity at its worst for each of the 7 items on a 0 (Absent) to 10 (Worst Imaginable) numeric rating scale.
Baseline and pre-specified timepoints up to Week 52
Change From Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score
Time Frame: Baseline and pre-specified timepoints up to Week 52
The PROMIS F SF-7a is a 7-item participant-reported assessment that measures both the experience of fatigue and the interference of fatigue on daily activities over the past week. Response options are on a 5-point Likert scale, ranging from 1 = never to 5 = always.
Baseline and pre-specified timepoints up to Week 52
Change From Baseline in MFSAF v4.0 Total Symptom Score
Time Frame: Baseline and Week 52
The MFSAF v4.0 is a 7-item participant-reported myelofibrosis symptom assessment which asks respondents to report symptom severity at its worst for each of the 7 items on a 0 (Absent) to 10 (Worst Imaginable) numeric rating scale. The change from baseline in MFSAF total score for all symptoms will be presented.
Baseline and Week 52
Duration of Hematologic Remission (DOHR)
Time Frame: Up to Week 52
For participants who demonstrate hematologic remission, DOHR is defined as the time from the first documented evidence of platelet and WBC counts reduction until platelet or WBC counts increase to above acceptable threshold.
Up to Week 52
Number of Participants Who Experience Thrombotic Events
Time Frame: Up to approximately 52 weeks
Thrombotic events include but are not limited to new or recurrent acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep venous thrombosis, pulmonary embolism, thrombotic digital ischemia, or other thrombotic events.
Up to approximately 52 weeks
Number of Participants Who Experience Major Hemorrhagic Events
Time Frame: Up to approximately 52 weeks
Major hemorrhagic events include but are not limited to fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a decrease in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells.
Up to approximately 52 weeks
Disease Progression Rate
Time Frame: Up to Week 52
Disease progression rate is the percentage of participants with disease progression, defined as the transformation to post-essential thrombocythemia myelofibrosis, myelodysplastic syndrome, or AML as assessed by the adjudication committee.
Up to Week 52
Number of Participants Who Experience One or More Adverse Events (AEs)
Time Frame: Up to approximately 52 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 52 weeks
Number of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately 52 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2024

Primary Completion (Estimated)

September 28, 2027

Study Completion (Estimated)

March 24, 2028

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3543-007
  • MK-3543-007 (Other Identifier: MSD)
  • jRCT2031240181 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
  • U1111-1290-8287 (Registry Identifier: UTN)
  • 2023-505232-36-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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