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Recruiting Phase 3 NCT06456346

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

Phase 3 – large-scale trial before approval
Conditions: Essential Thrombocythemia

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Bomedemstat
DRUG
Hydroxyurea
DRUG
Bomedemstat placebo
DRUG
Hydroxyurea placebo
DRUG
Locations 166
Argentina (4)
Hospital Italiano de Buenos Aires ( Site 0102)
ABB , Buenos Aires F.D.
Study Coordinator
Hospital Universitario Austral ( Site 0101)
Pilar , Buenos Aires
Study Coordinator
C.I.C.E. 9 de Julio ( Site 0104)
San Miguel de Tucumán , Tucumán Province
Study Coordinator
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105)
Santa Fe
Study Coordinator
Australia (5)
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203)
Adelaide , South Australia
Study Coordinator
Monash Health-Haematology Research ( Site 0202)
Clayton , Victoria
Study Coordinator
Austin Health-Cancer Clinical Trials Centre ( Site 0206)
Heidelberg , Victoria
Study Coordinator
Royal Perth Hospital-Haematology ( Site 0204)
Perth , Western Australia
Study Coordinator
Westmead Hospital ( Site 0201)
Westmead , New South Wales
COMPLETED
Austria (1)
Ordensklinikum Linz GmbH Elisabethinen ( Site 0562)
Linz , Upper Austria
Study Coordinator
Canada (2)
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0038)
Calgary , Alberta
Study Coordinator
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0037)
Greenfield Park , Quebec
Study Coordinator
Chile (6)
Biocenter ( Site 0149)
Concepción , Biobio
Study Coordinator
IC La Serena Research ( Site 0150)
La Serena , Coquimbo Region
ACTIVE_NOT_RECRUITING
FALP-UIDO ( Site 0148)
Santiago , Region M. de Santiago
ACTIVE_NOT_RECRUITING
Clínica Inmunocel ( Site 0147)
Santiago , Region M. de Santiago
Study Coordinator
Clínica Alemana de Santiago ( Site 0143)
Santiago , Region M. de Santiago
ACTIVE_NOT_RECRUITING
Bradfordhill-Clinical Area ( Site 0142)
Santiago , Region M. de Santiago
Study Coordinator
China (24)
Peking University Third Hospital-Hematology ( Site 0659)
Beijing , Beijing Municipality
Study Coordinator
Chinese Academy of medical science, Peking Union Medical College Hospital(Dongdan) ( Site 0675)
Beijing , Beijing Municipality
Study Coordinator
The First Afflilated Hospital of Bengbu Medical College ( Site 0651)
Bengbu , Anhui
Study Coordinator
The First Hospital of Jilin University-Hematology ( Site 0672)
Changchun , Jilin
Study Coordinator
West China Hospital, Sichuan University ( Site 0661)
Chengdu , Sichuan
Study Coordinator
Chongqing University Cancer Hospital ( Site 0666)
Chongqing , Chongqing Municipality
Study Coordinator
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-hematology department ( Site 0668)
Guangzhou , Guangdong
Study Coordinator
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 0655)
Guangzhou , Guangdong
Study Coordinator
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 0646)
Hangzhou , Zhejiang
Study Coordinator
Anhui Provincial Hospital ( Site 0657)
Hefei , Anhui
Study Coordinator
Jinan Central Hospital ( Site 0667)
Jinan , Shandong
Study Coordinator
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0645)
Nanchang , Jiangxi
Study Coordinator
The Second Affiliated Hospital of Fujian Medical University ( Site 0671)
Quanzhou , Fujian
Study Coordinator
Zhongshan Hospital,Fudan University-Hematology ( Site 0674)
Shanghai , Shanghai Municipality
Study Coordinator
Huashan Hospital, Fudan University ( Site 0669)
Shanghai , Shanghai Municipality
Study Coordinator
The Second Afilliated Hospital of Hebei Medical University ( Site 0650)
Shijiazhuang , Hebei
Study Coordinator
The First Hospital of Hebei Medical University ( Site 0649)
Shijiazhuang , Hebei
Study Coordinator
The First Affiliated Hospital of Soochow University ( Site 0676)
Suzhou , Jiangsu
Study Coordinator
Institute of hematology&blood disease hospital-Hematology ( Site 0641)
Tianjin , Tianjin Municipality
Study Coordinator
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0642)
Wuhan , Hubei
ACTIVE_NOT_RECRUITING
Shaanxi provincial people's hospital ( Site 0652)
Xi'an , Shaanxi
Study Coordinator
The First Affiliated hospital of Xiamen University ( Site 0658)
Xiamen , Fujian
Study Coordinator
Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 0662)
Yiwu , Zhejiang
Study Coordinator
Henan Cancer Hospital-hematology department ( Site 0644)
Zhengzhou , Henan
Study Coordinator
Colombia (3)
Los Cobos Medical Center ( Site 0165)
Bogotá , Bogota D.C.
ACTIVE_NOT_RECRUITING
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0164)
Medellín , Antioquia
ACTIVE_NOT_RECRUITING
IMAT S.A.S ( Site 0162)
Montería , Departamento de Córdoba
ACTIVE_NOT_RECRUITING
Denmark (4)
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324)
Aarhus , Central Jutland
Study Coordinator
Rigshospitalet-Hematology - CTU ( Site 0321)
Copenhagen , Capital Region
Study Coordinator
Odense Universitetshospital-Department of Hematology ( Site 0325)
Odense C , Region Syddanmark
Study Coordinator
Roskilde Sygehus-Department of Hematology ( Site 0323)
Roskilde , Region Sjælland
Study Coordinator
France (10)
HENRI MONDOR HOSPITAL ( Site 0348)
Créteil , Val-de-Marne
COMPLETED
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0344)
Limoges , Haute-Vienne
COMPLETED
Hôpital de la Conception ( Site 0351)
Marseille , Bouches-du-Rhone
Study Coordinator
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0347)
Nantes , Pays de la Loire Region
COMPLETED
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology ( Site 0349)
Nice , Alpes-Maritimes
Study Coordinator
Hopital Saint-Louis ( Site 0341)
Paris
Study Coordinator
CHU Bordeaux Haut-Leveque-service de mèdecine interne et maladies infectieuses ( Site 0346)
Pessac , Aquitaine
Study Coordinator
centre hospitalier lyon sud ( Site 0343)
Pierre-Bénite , Rhone
Study Coordinator
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0352)
Toulouse , Haute-Garonne
Study Coordinator
Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0342)
Tours , Indre-et-Loire
Study Coordinator
Germany (8)
Universitätsklinikum Aachen ( Site 0367)
Aachen , North Rhine-Westphalia
ACTIVE_NOT_RECRUITING
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0369)
Berlin
COMPLETED
Universitaetsklinikum Essen ( Site 0366)
Essen , North Rhine-Westphalia
ACTIVE_NOT_RECRUITING
Universitätsklinikum Halle ( Site 0361)
Halle , Saxony-Anhalt
Study Coordinator
Medizinische Hochschule Hannover ( Site 0371)
Hanover , Lower Saxony
COMPLETED
Universitätsklinikum Jena-Klinik für Innere Medizin II, Abt. Hämatologie und Internistische Onkolog ( Site 0364)
Jena , Thuringia
Study Coordinator
VK&K Studien GbR ( Site 0370)
Landshut , Bavaria
ACTIVE_NOT_RECRUITING
Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Site 0365)
Mainz , Rhineland-Palatinate
ACTIVE_NOT_RECRUITING
Hong Kong (1)
Queen Mary Hospital ( Site 0221)
Hksar
Study Coordinator
Hungary (5)
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
Debrecen
Study Coordinator
Petz Aladar Egyetemi Oktato Korhaz-Hematológia ( Site 0405)
Győr , Győr-Moson-Sopron
Study Coordinator
Somogy Vármegyei Kaposi Mór Oktató Kórház-Haematológiai osztály ( Site 0406)
Kaposvár , Somogy County
Study Coordinator
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0404)
Nyíregyháza , Szabolcs-Szatmár-Bereg
Study Coordinator
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 0407)
Szeged , Csongrád megye
Study Coordinator
Israel (9)
Soroka Medical Center ( Site 0427)
Beersheba
Study Coordinator
Rambam Health Care Campus ( Site 0429)
Haifa
Study Coordinator
Carmel Hospital ( Site 0426)
Haifa
Study Coordinator
Hadassah Medical Center ( Site 0424)
Jerusalem
Study Coordinator
Galilee Medical Center ( Site 0431)
Nahariya
Study Coordinator
Rabin Medical Center ( Site 0425)
Petah Tikva
Study Coordinator
Sheba Medical Center ( Site 0428)
Ramat Gan
Study Coordinator
Sourasky Medical Center ( Site 0422)
Tel Aviv
Study Coordinator
Yitzhak Shamir Medical Center. ( Site 0421)
Ẕerifin
Study Coordinator
Italy (7)
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0443)
Alessandria
Study Coordinator
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0446)
Bologna
Study Coordinator
Azienda Ospedaliera Universitaria Careggi ( Site 0441)
Florence , Tuscany
Study Coordinator
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0447)
Milan
ACTIVE_NOT_RECRUITING
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0444)
Pavia
COMPLETED
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0445)
Roma
Study Coordinator
Ospedale di Circolo e Fondazione Macchi Varese ( Site 0442)
Varese
Study Coordinator
Japan (16)
Juntendo University Hospital ( Site 0611)
Bunkyo-ku , Tokyo
COMPLETED
University of Yamanashi Hospital ( Site 0606)
Chūō , Yamanashi
ACTIVE_NOT_RECRUITING
Kyushu University Hospital ( Site 0605)
Fukuoka
COMPLETED
Fukushima Medical University Hospital ( Site 0616)
Fukushima
ACTIVE_NOT_RECRUITING
Kansai Medical University Hospital ( Site 0607)
Hirakata , Osaka
ACTIVE_NOT_RECRUITING
Kanazawa University Hospital ( Site 0614)
Kanazawa , Ishikawa-ken
ACTIVE_NOT_RECRUITING
Kobe City Medical Center General Hospital ( Site 0603)
Kobe , Hyōgo
COMPLETED
University of Miyazaki Hospital ( Site 0609)
Miyazaki
ACTIVE_NOT_RECRUITING
Okayama University Hospital ( Site 0604)
Okayama
ACTIVE_NOT_RECRUITING
Kindai University Hospital ( Site 0600)
Sakai , Osaka
ACTIVE_NOT_RECRUITING
Hokkaido University Hospital ( Site 0601)
Sapporo , Hokkaido
ACTIVE_NOT_RECRUITING
National Hospital Organization Sendai Medical Center ( Site 0617)
Sendai , Miyagi
ACTIVE_NOT_RECRUITING
Nippon Medical School Hospital ( Site 0608)
Tokyo
ACTIVE_NOT_RECRUITING
Ehime University Hospital ( Site 0612)
Tōon , Ehime
ACTIVE_NOT_RECRUITING
Fujita Health University Hospital ( Site 0613)
Toyoake , Aichi-ken
ACTIVE_NOT_RECRUITING
Mie University Hospital ( Site 0615)
Tsu , Mie-ken
ACTIVE_NOT_RECRUITING
Mexico (3)
Medivest Centro de Investigación Integral ( Site 0183)
Chihuahua City , Chihuahua
ACTIVE_NOT_RECRUITING
Higiea Oncologia ( Site 0184)
Mexico City , Mexico City
ACTIVE_NOT_RECRUITING
Centro de Investigacion Clinica de Oaxaca ( Site 0181)
Oaxaca City , Oaxaca
ACTIVE_NOT_RECRUITING
Poland (3)
Pratia Onkologia Katowice ( Site 0461)
Katowice , Silesian Voivodeship
Study Coordinator
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 0466)
Kielce , Świętokrzyskie Voivodeship
Study Coordinator
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp ( Site 0463)
Lublin , Lublin Voivodeship
Study Coordinator
Spain (10)
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0490)
Badalona , Barcelona
Study Coordinator
HOSPITAL CLÍNIC DE BARCELONA ( Site 0481)
Barcelona , Catalonia
Study Coordinator
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0489)
Barcelona
Study Coordinator
Institut Català d'Oncologia - L'Hospitalet ( Site 0482)
L'Hospitalet de Llobregat , Catalonia
Study Coordinator
Clinica Universidad de Navarra-Hematology Department ( Site 0485)
Madrid , Madrid, Comunidad de
Study Coordinator
Hospital Universitario Ramón y Cajal-Hematology ( Site 0484)
Madrid , Madrid, Comunidad de
Study Coordinator
Hospital Universitario 12 de Octubre ( Site 0494)
Madrid
Study Coordinator
Hospital Costa del Sol-Hematology Service ( Site 0493)
Marbella , Malaga
COMPLETED
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 0488)
Salamanca
COMPLETED
Hospital Universitario Marqués de Valdecilla-Haematology ( Site 0486)
Santander , Cantabria
ACTIVE_NOT_RECRUITING
Sweden (5)
Sahlgrenska Universitetssjukhuset-Department of hematology and coagulation ( Site 0543)
Gothenburg , Västra Götaland County
Study Coordinator
Karolinska Universitetssjukhuset Huddinge ( Site 0541)
Huddinge , Stockholm County
Study Coordinator
Skånes Universitetssjukhus Lund-Department of Hematology ( Site 0544)
Lund , Skåne County
Study Coordinator
Universitetssjukhuset Örebro ( Site 0542)
Örebro , Örebro County
Study Coordinator
Akademiska sjukhuset ( Site 0545)
Uppsala , Uppsala County
Study Coordinator
Taiwan (4)
Chang Gung Memorial Hospital- Chiayi ( Site 0242)
Chiayi City , Chiayi
Study Coordinator
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0245)
Tainan
Study Coordinator
National Taiwan University Hospital ( Site 0241)
Taipei
Study Coordinator
Chang Gung Medical Foundation-Linkou Branch ( Site 0243)
Taoyuan District
Study Coordinator
Turkey (10)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-Hemotology ( Site 0510)
Ankara
Study Coordinator
Hacettepe Universite Hastaneleri-Department of Hematology ( Site 0505)
Ankara
Study Coordinator
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0502)
Ankara
Study Coordinator
Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 0511)
Ankara
Study Coordinator
Antalya Egitim ve Arastırma Hastanesi ( Site 0508)
Antalya
Study Coordinator
Ege Universitesi Hastanesi ( Site 0503)
Bornova , İzmir
Study Coordinator
Trakya University Medical Faculty Hospital-Hematology ( Site 0501)
Edirne
Study Coordinator
Medipol Mega Universite Hastanesi ( Site 0504)
Istanbul
Study Coordinator
Kocaeli Üniversitesi-Hematology ( Site 0506)
Kocaeli
Study Coordinator
Ondokuz Mayıs Universitesi-hematology ( Site 0507)
Samsun
Study Coordinator
United Kingdom (9)
Glan Clwyd Hospital ( Site 0528)
Bodelwyddan , Denbighshire
Study Coordinator
Boston Pilgrim Hospital ( Site 0525)
Boston , Lincolnshire
Study Coordinator
Gloucestershire Royal Hospital ( Site 0521)
Gloucester , Gloucestershire
Study Coordinator
Lincoln County Hospital ( Site 0535)
Lincoln , Great Britain
Study Coordinator
University College London Hospital ( Site 0527)
London , London, City of
ACTIVE_NOT_RECRUITING
Guy's & St Thomas' NHS Foundation Trust ( Site 0523)
London , London, City of
ACTIVE_NOT_RECRUITING
Hammersmith Hospital ( Site 0533)
London , London, City of
Study Coordinator
Freeman Hospital ( Site 0532)
Newcastle upon Tyne
Study Coordinator
Royal Gwent Hospital ( Site 0524)
Newport
Study Coordinator
United States (17)
University of Michigan ( Site 0003)
Ann Arbor , Michigan
Study Coordinator
Levine Cancer Institute ( Site 0009)
Charlotte , North Carolina
Study Coordinator
University of Virginia ( Site 0020)
Charlottesville , Virginia
Study Coordinator
The Ohio State University Wexner Medical Center ( Site 0028)
Columbus , Ohio
Study Coordinator
Duke University Health System (DUHS) ( Site 0012)
Durham , North Carolina
Study Coordinator
Parkview Research Center at Parkview Regional Medical Center ( Site 0006)
Fort Wayne , Indiana
COMPLETED
Palo Verde Cancer Specialists ( Site 0052)
Glendale , Arizona
Study Coordinator
Los Angeles Cancer Network ( Site 0025)
Glendale , California
Study Coordinator
Exempla Lutheran Medical Center ( Site 0014)
Golden , Colorado
Study Coordinator
University of Texas MD Anderson Cancer Center ( Site 0026)
Houston , Texas
Study Coordinator
Optum Care Cancer Center ( Site 0053)
Las Vegas , Nevada
Study Coordinator
Yale University School of Medicine ( Site 0051)
New Haven , Connecticut
Study Coordinator
Stanford Cancer Center ( Site 0024)
Palo Alto , California
Study Coordinator
Oregon Health & Science University ( Site 0018)
Portland , Oregon
Study Coordinator
VCU Health Adult Outpatient Pavillion ( Site 0008)
Richmond , Virginia
Study Coordinator
University of Texas Health Science Center at San Antonio ( Site 0021)
San Antonio , Texas
Study Coordinator
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013)
Winston-Salem , North Carolina
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.07.2024
Completion date
24.03.2028
Registry ID
NCT06456346
Source
clinicaltrials.gov
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