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Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-07-16
Completion Date
2028-03-24
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
Bomedemstat
Oral capsule
Hydroxyurea
Oral capsule
Bomedemstat placebo
Oral capsule placebo
Hydroxyurea placebo
Oral capsule placebo
Locations (171)
Palo Verde Cancer Specialists ( Site 0052)
Glendale, Arizona, United States
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
Yale University School of Medicine ( Site 0051)
New Haven, Connecticut, 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
Optum Care Cancer Center ( Site 0053)
Las Vegas, Nevada, 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
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8005)
Eugene, Oregon, United States
Oregon Health & Science University ( Site 0018)
Portland, Oregon, United States
TriStar Bone Marrow ( Site 7000)
Nashville, Tennessee, United States
Texas Oncology - West Texas ( Site 8003)
Amarillo, Texas, United States
Texas Oncology - DFW ( Site 8006)
Dallas, Texas, 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
Texas Oncology - Gulf Coast ( Site 8008)
Webster, 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
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0038)
Calgary, Alberta, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0037)
Greenfield Park, Quebec, Canada
Biocenter ( Site 0149)
Concepción, Biobio, Chile
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
The First Afflilated Hospital of Bengbu Medical College ( Site 0651)
Bengbu, Anhui, China
Anhui Provincial Hospital ( Site 0657)
Hefei, Anhui, China
Peking University Third Hospital-Hematology ( Site 0659)
Beijing, Beijing Municipality, China
Chinese Academy of medical science, Peking Union Medical College Hospital(Dongdan) ( Site 0675)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 0666)
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Fujian Medical University ( Site 0671)
Quanzhou, Fujian, China
The First Affiliated hospital of Xiamen University ( Site 0658)
Xiamen, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-hematology department ( Site 0668)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 0655)
Guangzhou, Guangdong, China
The Second Afilliated Hospital of Hebei Medical University ( Site 0650)
Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University ( Site 0649)
Shijiazhuang, Hebei, China
Henan Cancer Hospital-hematology department ( Site 0644)
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0642)
Wuhan, Hubei, China
The First Affiliated Hospital of Soochow University ( Site 0676)
Suzhou, Jiangsu, China
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0645)
Nanchang, Jiangxi, China
The First Hospital of Jilin University-Hematology ( Site 0672)
Changchun, Jilin, China
Shaanxi provincial people's hospital ( Site 0652)
Xi'an, Shaanxi, China
Jinan Central Hospital ( Site 0667)
Jinan, Shandong, China
Zhongshan Hospital,Fudan University-Hematology ( Site 0674)
Shanghai, Shanghai Municipality, China
Huashan Hospital, Fudan University ( Site 0669)
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University ( Site 0661)
Chengdu, Sichuan, China
Institute of hematology&blood disease hospital-Hematology ( Site 0641)
Tianjin, Tianjin Municipality, China
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 0646)
Hangzhou, Zhejiang, China
Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 0662)
Yiwu, Zhejiang, China
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, Pays de la Loire Region, 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
VK&K Studien GbR ( Site 0370)
Landshut, Bavaria, Germany
Medizinische Hochschule Hannover ( Site 0371)
Hanover, Lower Saxony, Germany
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