Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
NCT ID: NCT06456346
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2024-07-16
2028-03-24
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Hydroxyurea placebo
Oral capsule placebo
Bomedemstat
Oral capsule
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.
Bomedemstat placebo
Oral capsule placebo
Hydroxyurea
Oral capsule
Interventions
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Bomedemstat placebo
Oral capsule placebo
Hydroxyurea placebo
Oral capsule placebo
Bomedemstat
Oral capsule
Hydroxyurea
Oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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VK&K Studien GbR ( Site 0370)
Landshut, Bavaria, Germany
Medizinische Hochschule Hannover ( Site 0371)
Hanover, Lower Saxony, Germany
Los Angeles Cancer Network ( Site 0025)
Glendale, California, United States
Stanford Cancer Center ( Site 0024)
Palo Alto, California, United States
Exempla Lutheran Medical Center ( Site 0014)
Golden, Colorado, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0006)
Fort Wayne, Indiana, United States
University of Michigan ( Site 0003)
Ann Arbor, Michigan, United States
Levine Cancer Institute ( Site 0009)
Charlotte, North Carolina, United States
Duke University Health System (DUHS) ( Site 0012)
Durham, North Carolina, United States
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013)
Winston-Salem, North Carolina, United States
The Ohio State University Wexner Medical Center ( Site 0028)
Columbus, Ohio, United States
Oregon Health & Science University ( Site 0018)
Portland, Oregon, United States
University of Texas MD Anderson Cancer Center ( Site 0026)
Houston, Texas, United States
University of Texas Health Science Center at San Antonio ( Site 0021)
San Antonio, Texas, United States
University of Virginia ( Site 0020)
Charlottesville, Virginia, United States
VCU Health Adult Outpatient Pavillion ( Site 0008)
Richmond, Virginia, United States
Hospital Universitario Austral ( Site 0101)
Pilar, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires ( Site 0102)
ABB, Buenos Aires F.D., Argentina
C.I.C.E. 9 de Julio ( Site 0104)
San Miguel de Tucumán, Tucumán Province, Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105)
Santa Fe, , Argentina
Westmead Hospital ( Site 0201)
Westmead, New South Wales, Australia
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203)
Adelaide, South Australia, Australia
Monash Health-Haematology Research ( Site 0202)
Clayton, Victoria, Australia
Austin Health-Cancer Clinical Trials Centre ( Site 0206)
Heidelberg, Victoria, Australia
Royal Perth Hospital-Haematology ( Site 0204)
Perth, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen ( Site 0562)
Linz, Upper Austria, Austria
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0037)
Greenfield Park, Quebec, Canada
IC La Serena Research ( Site 0150)
La Serena, Coquimbo Region, Chile
FALP-UIDO ( Site 0148)
Santiago, Region M. de Santiago, Chile
Clínica Inmunocel ( Site 0147)
Santiago, Region M. de Santiago, Chile
Clínica Alemana de Santiago ( Site 0143)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0142)
Santiago, Region M. de Santiago, Chile
Biocenter ( Site 0149)
Concepción, Región del Biobío, Chile
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0164)
Medellín, Antioquia, Colombia
Los Cobos Medical Center ( Site 0165)
Bogotá, Bogota D.C., Colombia
IMAT S.A.S ( Site 0162)
Montería, Departamento de Córdoba, Colombia
Rigshospitalet-Hematology - CTU ( Site 0321)
Copenhagen, Capital Region, Denmark
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324)
Aarhus, Central Jutland, Denmark
Roskilde Sygehus-Department of Hematology ( Site 0323)
Roskilde, Region Sjælland, Denmark
Odense Universitetshospital-Department of Hematology ( Site 0325)
Odense C, Region Syddanmark, Denmark
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology ( Site 0349)
Nice, Alpes-Maritimes, France
CHU Bordeaux Haut-Leveque-service de mèdecine interne et maladies infectieuses ( Site 0346)
Pessac, Aquitaine, France
Hôpital de la Conception ( Site 0351)
Marseille, Bouches-du-Rhone, France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0352)
Toulouse, Haute-Garonne, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0344)
Limoges, Haute-Vienne, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0342)
Tours, Indre-et-Loire, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0347)
Nantes, Loire-Atlantique, France
centre hospitalier lyon sud ( Site 0343)
Pierre-Bénite, Rhone, France
HENRI MONDOR HOSPITAL ( Site 0348)
Créteil, Val-de-Marne, France
Hopital Saint-Louis ( Site 0341)
Paris, , France
Universitätsklinikum Aachen ( Site 0367)
Aachen, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen ( Site 0366)
Essen, North Rhine-Westphalia, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Site 0365)
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Halle ( Site 0361)
Halle, Saxony-Anhalt, Germany
Universitätsklinikum Jena-Klinik für Innere Medizin II, Abt. Hämatologie und Internistische Onkolog ( Site 0364)
Jena, Thuringia, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0369)
Berlin, , Germany
Queen Mary Hospital ( Site 0221)
Hksar, , Hong Kong
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 0407)
Szeged, Csongrád megye, Hungary
Petz Aladar Egyetemi Oktato Korhaz-Hematológia ( Site 0405)
Győr, Győr-Moson-Sopron, Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház-Haematológiai osztály ( Site 0406)
Kaposvár, Somogy County, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0404)
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
Debrecen, , Hungary
Soroka Medical Center ( Site 0427)
Beersheba, , Israel
Rambam Health Care Campus ( Site 0429)
Haifa, , Israel
Carmel Hospital ( Site 0426)
Haifa, , Israel
Hadassah Medical Center ( Site 0424)
Jerusalem, , Israel
Galilee Medical Center ( Site 0431)
Nahariya, , Israel
Rabin Medical Center ( Site 0425)
Petah Tikva, , Israel
Sheba Medical Center ( Site 0428)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 0422)
Tel Aviv, , Israel
Yitzhak Shamir Medical Center. ( Site 0421)
Ẕerifin, , Israel
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0443)
Alessandria, Ancona, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0447)
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 0441)
Florence, Tuscany, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0446)
Bologna, , Italy
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0444)
Pavia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0445)
Roma, , Italy
Ospedale di Circolo e Fondazione Macchi Varese ( Site 0442)
Varese, , Italy
Fujita Health University Hospital ( Site 0613)
Toyoake, Aichi-ken, Japan
Ehime University Hospital ( Site 0612)
Tōon, Ehime, Japan
Hokkaido University Hospital ( Site 0601)
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital ( Site 0603)
Kobe, Hyōgo, Japan
Kanazawa University Hospital ( Site 0614)
Kanazawa, Ishikawa-ken, Japan
Mie University Hospital ( Site 0615)
Tsu, Mie-ken, Japan
National Hospital Organization Sendai Medical Center ( Site 0617)
Sendai, Miyagi, Japan
Kansai Medical University Hospital ( Site 0607)
Hirakata, Osaka, Japan
Kindai University Hospital ( Site 0600)
Sakai, Osaka, Japan
Juntendo University Hospital ( Site 0611)
Bunkyo-ku, Tokyo, Japan
University of Yamanashi Hospital ( Site 0606)
Chūō, Yamanashi, Japan
Kyushu University Hospital ( Site 0605)
Fukuoka, , Japan
Fukushima Medical University Hospital ( Site 0616)
Fukushima, , Japan
University of Miyazaki Hospital ( Site 0609)
Miyazaki, , Japan
Okayama University Hospital ( Site 0604)
Okayama, , Japan
Nippon Medical School Hospital ( Site 0608)
Tokyo, , Japan
Medivest Centro de Investigación Integral ( Site 0183)
Chihuahua City, Chihuahua, Mexico
Higiea Oncologia ( Site 0184)
Mexico City, Mexico City, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0181)
Oaxaca City, Oaxaca, Mexico
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp ( Site 0463)
Lublin, Lublin Voivodeship, Poland
Pratia Onkologia Katowice ( Site 0461)
Katowice, Silesian Voivodeship, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 0466)
Kielce, Świętokrzyskie Voivodeship, Poland
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0490)
Badalona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla-Haematology ( Site 0486)
Santander, Cantabria, Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 0481)
Barcelona, Catalonia, Spain
Institut Català d'Oncologia - L'Hospitalet ( Site 0482)
L'Hospitalet de Llobregat, Catalonia, Spain
Clinica Universidad de Navarra-Hematology Department ( Site 0485)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Ramón y Cajal-Hematology ( Site 0484)
Madrid, Madrid, Comunidad de, Spain
Hospital Costa del Sol-Hematology Service ( Site 0493)
Marbella, Malaga, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0489)
Barcelona, , Spain
Hospital Universitario 12 de Octubre ( Site 0494)
Madrid, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 0488)
Salamanca, , Spain
Skånes Universitetssjukhus Lund-Department of Hematology ( Site 0544)
Lund, Skåne County, Sweden
Karolinska Universitetssjukhuset Huddinge ( Site 0541)
Huddinge, Stockholm County, Sweden
Akademiska sjukhuset ( Site 0545)
Uppsala, Uppsala County, Sweden
Sahlgrenska Universitetssjukhuset-Department of hematology and coagulation ( Site 0543)
Gothenburg, Västra Götaland County, Sweden
Universitetssjukhuset Örebro ( Site 0542)
Örebro, Örebro County, Sweden
Chang Gung Memorial Hospital- Chiayi ( Site 0242)
Chiayi City, Chiayi, Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0245)
Tainan, , Taiwan
National Taiwan University Hospital ( Site 0241)
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0243)
Taoyuan District, , Taiwan
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-Hemotology ( Site 0510)
Ankara, , Turkey (Türkiye)
Hacettepe Universite Hastaneleri-Department of Hematology ( Site 0505)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0502)
Ankara, , Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi ( Site 0508)
Antalya, , Turkey (Türkiye)
Trakya University Medical Faculty Hospital-Hematology ( Site 0501)
Edirne, , Turkey (Türkiye)
Medipol Mega Universite Hastanesi ( Site 0504)
Istanbul, , Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 0503)
Izmir, , Turkey (Türkiye)
Kocaeli Üniversitesi-Hematology ( Site 0506)
Kocaeli, , Turkey (Türkiye)
Ondokuz Mayıs Universitesi-hematology ( Site 0507)
Samsun, , Turkey (Türkiye)
Glan Clwyd Hospital ( Site 0528)
Bodelwyddan, Denbighshire, United Kingdom
Gloucestershire Royal Hospital ( Site 0521)
Gloucester, Gloucestershire, United Kingdom
Lincoln County Hospital ( Site 0535)
Lincoln, Great Britain, United Kingdom
Boston Pilgrim Hospital ( Site 0525)
Boston, Lincolnshire, United Kingdom
University College London Hospital ( Site 0527)
London, London, City of, United Kingdom
Guy's & St Thomas' NHS Foundation Trust ( Site 0523)
London, London, City of, United Kingdom
Hammersmith Hospital ( Site 0533)
London, London, City of, United Kingdom
Freeman Hospital ( Site 0532)
Newcastle upon Tyne, , United Kingdom
Royal Gwent Hospital ( Site 0524)
Newport, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2023-505232-36-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-3543-007
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031240181
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1290-8287
Identifier Type: REGISTRY
Identifier Source: secondary_id
3543-007
Identifier Type: -
Identifier Source: org_study_id