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

Last updated: April 16, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Thrombosis

Platelet Disorders

Leukemia (Pediatric)

Treatment

Hydroxyurea placebo

Bomedemstat placebo

Hydroxyurea

Clinical Study ID

NCT06456346
3543-007
2023-505232-36
U1111-1290-8287
jRCT2031240181
MK-3543-007
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Essential Thrombocythemia (ET) based on World Health OrganizationCriteria for myeloproliferative neoplasms, and an indication for cytoreductivetherapy regardless of age or risk status

  • Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per amodified 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 onantiretroviral therapy

  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeksand have undetectable HBV viral load

  • Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCVviral load is undetectable

Exclusion

Exclusion Criteria:

  • History of any illness/impairment of gastrointestinal function that might interferewith drug absorption

  • History of a malignancy, unless potentially curative treatment has been completedwith no evidence of malignancy for 2 years

  • HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease

  • Has an active infection requiring systemic therapy

  • Has had a major surgery <4 weeks prior to first dose of study intervention or hasnot recovered from side effects of major surgery >4 weeks prior to first dose

Study Design

Total Participants: 300
Treatment Group(s): 4
Primary Treatment: Hydroxyurea placebo
Phase: 3
Study Start date:
July 16, 2024
Estimated Completion Date:
April 15, 2029

Connect with a study center

  • Hospital Universitario Austral ( Site 0101)

    Pilar, Buenos Aires B1629AHJ
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires ( Site 0102)

    ABB, Caba C1199ABB
    Argentina

    Active - Recruiting

  • C.I.C.E. 9 de Julio ( Site 0104)

    San Miguel de Tucumán, Tucuman T4000IKO
    Argentina

    Active - Recruiting

  • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105)

    Santa Fe, S3000BPJ
    Argentina

    Active - Recruiting

  • Westmead Hospital ( Site 0201)

    Westmead, New South Wales 2115
    Australia

    Active - Recruiting

  • Westmead Hospital-The Crown Princess Mary Cancer Care Centre ( Site 0201)

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203)

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Monash Health-Haematology Research ( Site 0202)

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Austin Health-Cancer Clinical Trials Centre ( Site 0206)

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Royal Perth Hospital-Haematology ( Site 0204)

    Perth, Western Australia 6000
    Australia

    Active - Recruiting

  • Ordensklinikum Linz GmbH Elisabethinen ( Site 0562)

    Linz, Oberosterreich 4020
    Austria

    Active - Recruiting

  • Biocenter ( Site 0149)

    Concepcion, Biobio 4070196
    Chile

    Active - Recruiting

  • IC La Serena Research ( Site 0150)

    La Serena, Coquimbo 1720430
    Chile

    Site Not Available

  • IC La Serena Research ( Site 0150)

    La Serena., Coquimbo 1720430
    Chile

    Active - Recruiting

  • Bradfordhill-Clinical Area ( Site 0142)

    Santiago, Region M. De Santiago 8420383
    Chile

    Active - Recruiting

  • Clínica Alemana de Santiago ( Site 0143)

    Santiago, Region M. De Santiago 7650568
    Chile

    Active - Recruiting

  • Clínica Inmunocel ( Site 0147)

    Santiago, Region M. De Santiago 7580206
    Chile

    Active - Recruiting

  • FALP-UIDO ( Site 0148)

    Santiago, Region M. De Santiago 7500921
    Chile

    Active - Recruiting

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 0164)

    Medellín, Antioquia 050030
    Colombia

    Active - Recruiting

  • IMAT S.A.S ( Site 0162)

    Monteria, Cordoba 230002
    Colombia

    Active - Recruiting

  • Oncomédica S.A.S ( Site 0162)

    Monteria, Cordoba 230002
    Colombia

    Active - Recruiting

  • Los Cobos Medical Center ( Site 0165)

    Bogota, Distrito Capital De Bogota 110121
    Colombia

    Active - Recruiting

  • Rigshospitalet-Hematology - CTU ( Site 0321)

    Copenhagen, Hovedstaden 2100
    Denmark

    Active - Recruiting

  • Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324)

    Aarhus, Midtjylland 8200
    Denmark

    Active - Recruiting

  • Roskilde Sygehus-Department of Hematology ( Site 0323)

    Roskilde, Sjaelland 4000
    Denmark

    Active - Recruiting

  • Odense Universitetshospital-Department of Hematology ( Site 0325)

    Odense C, Syddanmark 5000
    Denmark

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology ( Site 0349)

    Nice, Alpes-Maritimes 06202
    France

    Active - Recruiting

  • CHU Bordeaux Haut-Leveque-service de mèdecine interne et maladies infectieuses ( Site 0346)

    Pessac, Aquitaine 33600
    France

    Active - Recruiting

  • Hôpital de la Conception ( Site 0351)

    Marseille, Bouches-du-Rhone 13005
    France

    Active - Recruiting

  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0352)

    Toulouse, Haute-Garonne 31059
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0344)

    Limoges, Haute-Vienne 87042
    France

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Si

    Tours, Indre-et-Loire 37000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0347)

    Nantes, Loire-Atlantique 44000
    France

    Active - Recruiting

  • centre hospitalier lyon sud ( Site 0343)

    Pierre-Bénite, Rhone 69310
    France

    Active - Recruiting

  • HENRI MONDOR HOSPITAL ( Site 0348)

    Creteil, Val-de-Marne 94010
    France

    Active - Recruiting

  • Hopital Saint-Louis ( Site 0341)

    Paris, 75010
    France

    Active - Recruiting

  • VK&K Studien GbR ( Site 0370)

    Landshut, Bayern 84036
    Germany

    Active - Recruiting

  • Universitätsklinikum Aachen ( Site 0367)

    Aachen, Nordrhein-Westfalen 52074
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen ( Site 0366)

    Essen, Nordrhein-Westfalen 45147
    Germany

    Active - Recruiting

  • Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Sit

    Mainz, Rheinland-Pfalz 55131
    Germany

    Active - Recruiting

  • Universitätsklinikum Halle ( Site 0361)

    Halle, Sachsen-Anhalt 06120
    Germany

    Active - Recruiting

  • Universitätsklinikum Jena-Klinik für Innere Medizin II, Abt. Hämatologie und Internistische Onkolog

    Jena, Thuringen 07747
    Germany

    Active - Recruiting

  • Queen Mary Hospital ( Site 0221)

    Hksar,
    Hong Kong

    Active - Recruiting

  • Petz Aladar Egyetemi Oktato Korhaz-Hematológia ( Site 0405)

    Gyor, Gyor-Moson-Sopron 9024
    Hungary

    Active - Recruiting

  • Somogy Vármegyei Kaposi Mór Oktató Kórház-Haematológiai osztály ( Site 0406)

    Kaposvár, Somogy 7400
    Hungary

    Active - Recruiting

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0404)

    Nyiregyhaza, Szabolcs-Szatmar-Bereg 4400
    Hungary

    Active - Recruiting

  • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)

    Debrecen, 4032
    Hungary

    Active - Recruiting

  • Soroka Medical Center ( Site 0427)

    Be'er Sheva, 8410101
    Israel

    Active - Recruiting

  • Carmel Hospital ( Site 0426)

    Haifa, 3436212
    Israel

    Active - Recruiting

  • Rambam Health Care Campus ( Site 0429)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Hadassah Medical Center ( Site 0424)

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Rabin Medical Center ( Site 0425)

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 0428)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • Sourasky Medical Center ( Site 0422)

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Yitzhak Shamir Medical Center. ( Site 0421)

    Zerifin, 70300
    Israel

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0443)

    Alessandria, Ancona 15121
    Italy

    Active - Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0447)

    Milano, Lombardia 20122
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi ( Site 0441)

    Firenze, Toscana 50134
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo ( Site 0443)

    Alessandria, 15121
    Italy

    Active - Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0446)

    Bologna, 40138
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0444)

    Pavia, 27100
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (

    Roma, 00168
    Italy

    Active - Recruiting

  • Ospedale di Circolo e Fondazione Macchi Varese ( Site 0442)

    Varese, 21100
    Italy

    Active - Recruiting

  • Fujita Health University ( Site 0613)

    Toyoake, Aichi 470-1192
    Japan

    Active - Recruiting

  • Fujita Health University Hospital ( Site 0613)

    Toyoake, Aichi 470-1192
    Japan

    Active - Recruiting

  • Ehime University Hospital ( Site 0612)

    Toon, Ehime 791-0295
    Japan

    Active - Recruiting

  • Hokkaido University Hospital ( Site 0601)

    Sapporo, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital ( Site 0603)

    Kobe, Hyogo 650-0047
    Japan

    Active - Recruiting

  • Kanazawa University Hospital ( Site 0614)

    Kanazawa, Ishikawa 920-8641
    Japan

    Active - Recruiting

  • Mie University Hospital ( Site 0615)

    Tsu, Mie 514-8507
    Japan

    Active - Recruiting

  • National Hospital Organization Sendai Medical Center ( Site 0617)

    Sendai, Miyagi 983-8520
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital ( Site 0607)

    Hirakata, Osaka 573-1191
    Japan

    Active - Recruiting

  • Kindai University Hospital ( Site 0600)

    Osakasayama, Osaka 589-8511
    Japan

    Active - Recruiting

  • Kindai University Hospital- Osakasayama Campus-Hematology and Rheumatology ( Site 0600)

    Osakasayama, Osaka 589-8511
    Japan

    Active - Recruiting

  • Juntendo University Hospital ( Site 0611)

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • University of Yamanashi Hospital ( Site 0606)

    Chuo, Yamanashi 409-3898
    Japan

    Active - Recruiting

  • Kyushu University Hospital ( Site 0605)

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • Fukushima Medical University ( Site 0616)

    Fukushima, 960-1295
    Japan

    Active - Recruiting

  • Fukushima Medical University Hospital ( Site 0616)

    Fukushima, 960-1295
    Japan

    Active - Recruiting

  • University of Miyazaki Hospital ( Site 0609)

    Miyazaki, 889-1692
    Japan

    Active - Recruiting

  • Okayama University Hospital ( Site 0604)

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital ( Site 0608)

    Tokyo, 113-8603
    Japan

    Active - Recruiting

  • Medivest Centro de Investigación Integral ( Site 0183)

    Chihuahua City, Chihuahua 31203
    Mexico

    Active - Recruiting

  • Higiea Oncologia ( Site 0184)

    Mexico City, Distrito Federal 11819
    Mexico

    Active - Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 0181)

    Oaxaca de Juarez, Oaxaca 68020
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica de Oaxaca ( Site 0181)

    Oaxaca de Juarez., Oaxaca 68020
    Mexico

    Active - Recruiting

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp

    Lublin, Lubelskie 20-081
    Poland

    Active - Recruiting

  • Pratia Onkologia Katowice ( Site 0461)

    Katowice, Slaskie 40-519
    Poland

    Active - Recruiting

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S

    Kielce, Swietokrzyskie 25-734
    Poland

    Active - Recruiting

  • Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0490)

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla-Haematology ( Site 0486)

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 0481)

    Barcelona, Cataluna 08036
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia - L'Hospitalet ( Site 0482)

    L'Hospitalet de Llobregat, Cataluna 08908
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra-Hematology Department ( Site 0485)

    Madrid, Madrid, Comunidad De 28027
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal-Hematology ( Site 0484)

    Madrid, Madrid, Comunidad De 28034
    Spain

    Active - Recruiting

  • Hospital Costa del Sol-Hematology Service ( Site 0493)

    Marbella, Malaga 29603
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0489)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre ( Site 0494)

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( S

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Universitetssjukhuset Örebro ( Site 0542)

    Örebro, Orebro Lan 701 85
    Sweden

    Active - Recruiting

  • Skånes Universitetssjukhus Lund-Department of Hematology ( Site 0544)

    Lund, Skane Lan 22185
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset Huddinge ( Site 0541)

    Huddinge, Stockholms Lan 141 86
    Sweden

    Active - Recruiting

  • Akademiska sjukhuset ( Site 0545)

    Uppsala, Uppsala Lan 751 85
    Sweden

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset-Department of hematology and coagulation ( Site 0543)

    Gothenburg, Vastra Gotalands Lan 413 45
    Sweden

    Active - Recruiting

  • Chang Gung Memorial Hospital- Chiayi ( Site 0242)

    Chiayi City, Chiayi 613
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 0245)

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital ( Site 0241)

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch ( Site 0243)

    Taoyuan, 33305
    Taiwan

    Active - Recruiting

  • Glan Clwyd Hospital ( Site 0528)

    Bodelwyddan, Denbighshire LL18 5UJ
    United Kingdom

    Active - Recruiting

  • Royal Gwent Hospital ( Site 0524)

    Gwent, Newport NP20 2UB
    United Kingdom

    Active - Recruiting

  • Stanford Cancer Center ( Site 0024)

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Exempla Lutheran Medical Center ( Site 0014)

    Golden, Colorado 80401
    United States

    Active - Recruiting

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0006)

    Fort Wayne, Indiana 46845
    United States

    Completed

  • Duke University Health System (DUHS) ( Site 0012)

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Oregon Health & Science University ( Site 0018)

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • University of Virginia ( Site 0020)

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • VCU Health Adult Outpatient Pavillion ( Site 0008)

    Richmond, Virginia 23219
    United States

    Active - Recruiting

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