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
Status: Recruiting
Location: See all (137) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Los Angeles Cancer Network ( Site 0025)
RECRUITING
Glendale
Stanford Cancer Center ( Site 0024)
RECRUITING
Palo Alto
Colorado
Exempla Lutheran Medical Center ( Site 0014)
RECRUITING
Golden
Indiana
Parkview Research Center at Parkview Regional Medical Center ( Site 0006)
COMPLETED
Fort Wayne
Michigan
University of Michigan ( Site 0003)
RECRUITING
Ann Arbor
North Carolina
Levine Cancer Institute ( Site 0009)
RECRUITING
Charlotte
Duke University Health System (DUHS) ( Site 0012)
RECRUITING
Durham
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013)
RECRUITING
Winston-salem
Ohio
The Ohio State University Wexner Medical Center ( Site 0028)
RECRUITING
Columbus
Oregon
Oregon Health & Science University ( Site 0018)
RECRUITING
Portland
Texas
University of Texas MD Anderson Cancer Center ( Site 0026)
RECRUITING
Houston
University of Texas Health Science Center at San Antonio ( Site 0021)
RECRUITING
San Antonio
Virginia
University of Virginia ( Site 0020)
RECRUITING
Charlottesville
VCU Health Adult Outpatient Pavillion ( Site 0008)
RECRUITING
Richmond
Other Locations
Argentina
Hospital Italiano de Buenos Aires ( Site 0102)
RECRUITING
Abb
Hospital Universitario Austral ( Site 0101)
RECRUITING
Pilar
C.I.C.E. 9 de Julio ( Site 0104)
RECRUITING
San Miguel De Tucumán
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105)
RECRUITING
Santa Fe
Australia
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203)
RECRUITING
Adelaide
Monash Health-Haematology Research ( Site 0202)
RECRUITING
Clayton
Austin Health-Cancer Clinical Trials Centre ( Site 0206)
RECRUITING
Heidelberg
Royal Perth Hospital-Haematology ( Site 0204)
RECRUITING
Perth
Westmead Hospital ( Site 0201)
RECRUITING
Westmead
Austria
Ordensklinikum Linz GmbH Elisabethinen ( Site 0562)
RECRUITING
Linz
Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0037)
RECRUITING
Greenfield Park
Chile
Biocenter ( Site 0149)
RECRUITING
Concepción
IC La Serena Research ( Site 0150)
RECRUITING
La Serena
Bradfordhill-Clinical Area ( Site 0142)
RECRUITING
Santiago
Clínica Alemana de Santiago ( Site 0143)
RECRUITING
Santiago
Clínica Inmunocel ( Site 0147)
RECRUITING
Santiago
FALP-UIDO ( Site 0148)
RECRUITING
Santiago
Colombia
Los Cobos Medical Center ( Site 0165)
RECRUITING
Bogotá
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0164)
RECRUITING
Medellín
IMAT S.A.S ( Site 0162)
RECRUITING
Montería
Denmark
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324)
RECRUITING
Aarhus
Rigshospitalet-Hematology - CTU ( Site 0321)
RECRUITING
Copenhagen
Odense Universitetshospital-Department of Hematology ( Site 0325)
RECRUITING
Odense C
Roskilde Sygehus-Department of Hematology ( Site 0323)
RECRUITING
Roskilde
France
HENRI MONDOR HOSPITAL ( Site 0348)
RECRUITING
Créteil
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0344)
RECRUITING
Limoges
Hôpital de la Conception ( Site 0351)
RECRUITING
Marseille
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0347)
RECRUITING
Nantes
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology ( Site 0349)
RECRUITING
Nice
Hopital Saint-Louis ( Site 0341)
RECRUITING
Paris
CHU Bordeaux Haut-Leveque-service de mèdecine interne et maladies infectieuses ( Site 0346)
RECRUITING
Pessac
centre hospitalier lyon sud ( Site 0343)
RECRUITING
Pierre-bénite
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0352)
RECRUITING
Toulouse
Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0342)
RECRUITING
Tours
Germany
Universitätsklinikum Aachen ( Site 0367)
RECRUITING
Aachen
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0369)
RECRUITING
Berlin
Universitaetsklinikum Essen ( Site 0366)
RECRUITING
Essen
Universitätsklinikum Halle ( Site 0361)
RECRUITING
Halle
Medizinische Hochschule Hannover ( Site 0371)
RECRUITING
Hanover
Universitätsklinikum Jena-Klinik für Innere Medizin II, Abt. Hämatologie und Internistische Onkolog ( Site 0364)
RECRUITING
Jena
VK&K Studien GbR ( Site 0370)
RECRUITING
Landshut
Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Site 0365)
RECRUITING
Mainz
Hong Kong Special Administrative Region
Queen Mary Hospital ( Site 0221)
RECRUITING
Hksar
Hungary
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
RECRUITING
Debrecen
Petz Aladar Egyetemi Oktato Korhaz-Hematológia ( Site 0405)
RECRUITING
Győr
Somogy Vármegyei Kaposi Mór Oktató Kórház-Haematológiai osztály ( Site 0406)
RECRUITING
Kaposvár
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0404)
RECRUITING
Nyíregyháza
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 0407)
RECRUITING
Szeged
Israel
Soroka Medical Center ( Site 0427)
RECRUITING
Beersheba
Carmel Hospital ( Site 0426)
RECRUITING
Haifa
Rambam Health Care Campus ( Site 0429)
RECRUITING
Haifa
Hadassah Medical Center ( Site 0424)
RECRUITING
Jerusalem
Galilee Medical Center ( Site 0431)
RECRUITING
Nahariya
Rabin Medical Center ( Site 0425)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 0428)
RECRUITING
Ramat Gan
Sourasky Medical Center ( Site 0422)
RECRUITING
Tel Aviv
Yitzhak Shamir Medical Center. ( Site 0421)
RECRUITING
Ẕerifin
Italy
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0443)
RECRUITING
Alessandria
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0446)
RECRUITING
Bologna
Azienda Ospedaliera Universitaria Careggi ( Site 0441)
RECRUITING
Florence
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0447)
RECRUITING
Milan
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0444)
RECRUITING
Pavia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0445)
RECRUITING
Roma
Ospedale di Circolo e Fondazione Macchi Varese ( Site 0442)
RECRUITING
Varese
Japan
Juntendo University Hospital ( Site 0611)
RECRUITING
Bunkyo-ku
University of Yamanashi Hospital ( Site 0606)
RECRUITING
Chūō
Kyushu University Hospital ( Site 0605)
RECRUITING
Fukuoka
Fukushima Medical University Hospital ( Site 0616)
RECRUITING
Fukushima
Kansai Medical University Hospital ( Site 0607)
RECRUITING
Hirakata
Kanazawa University Hospital ( Site 0614)
RECRUITING
Kanazawa
Kobe City Medical Center General Hospital ( Site 0603)
RECRUITING
Kobe
University of Miyazaki Hospital ( Site 0609)
RECRUITING
Miyazaki
Okayama University Hospital ( Site 0604)
RECRUITING
Okayama
Hokkaido University Hospital ( Site 0601)
RECRUITING
Sapporo
Kindai University Hospital ( Site 0600)
RECRUITING
Sayama
National Hospital Organization Sendai Medical Center ( Site 0617)
RECRUITING
Sendai
Nippon Medical School Hospital ( Site 0608)
RECRUITING
Tokyo
Ehime University Hospital ( Site 0612)
RECRUITING
Tōon
Fujita Health University Hospital ( Site 0613)
RECRUITING
Toyoake
Mie University Hospital ( Site 0615)
RECRUITING
Tsu
Mexico
Medivest Centro de Investigación Integral ( Site 0183)
RECRUITING
Chihuahua City
Higiea Oncologia ( Site 0184)
RECRUITING
Mexico City
Centro de Investigacion Clinica de Oaxaca ( Site 0181)
RECRUITING
Oaxaca City
Poland
Pratia Onkologia Katowice ( Site 0461)
RECRUITING
Katowice
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 0466)
RECRUITING
Kielce
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp ( Site 0463)
RECRUITING
Lublin
Spain
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0490)
RECRUITING
Badalona
HOSPITAL CLÍNIC DE BARCELONA ( Site 0481)
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0489)
RECRUITING
Barcelona
Institut Català d'Oncologia - L'Hospitalet ( Site 0482)
RECRUITING
L'hospitalet De Llobregat
Clinica Universidad de Navarra-Hematology Department ( Site 0485)
RECRUITING
Madrid
Hospital Universitario 12 de Octubre ( Site 0494)
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal-Hematology ( Site 0484)
RECRUITING
Madrid
Hospital Costa del Sol-Hematology Service ( Site 0493)
RECRUITING
Marbella
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 0488)
RECRUITING
Salamanca
Hospital Universitario Marqués de Valdecilla-Haematology ( Site 0486)
RECRUITING
Santander
Sweden
Sahlgrenska Universitetssjukhuset-Department of hematology and coagulation ( Site 0543)
RECRUITING
Gothenburg
Karolinska Universitetssjukhuset Huddinge ( Site 0541)
RECRUITING
Huddinge
Skånes Universitetssjukhus Lund-Department of Hematology ( Site 0544)
RECRUITING
Lund
Universitetssjukhuset Örebro ( Site 0542)
RECRUITING
Örebro
Akademiska sjukhuset ( Site 0545)
RECRUITING
Uppsala
Taiwan
Chang Gung Memorial Hospital- Chiayi ( Site 0242)
RECRUITING
Chiayi City
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0245)
RECRUITING
Tainan City
National Taiwan University Hospital ( Site 0241)
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch ( Site 0243)
RECRUITING
Taoyuan District
Turkey
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0502)
RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-Hemotology ( Site 0510)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-Department of Hematology ( Site 0505)
RECRUITING
Ankara
Antalya Egitim ve Arastırma Hastanesi ( Site 0508)
RECRUITING
Antalya
Trakya University Medical Faculty Hospital-Hematology ( Site 0501)
RECRUITING
Edirne
Medipol Mega Universite Hastanesi ( Site 0504)
RECRUITING
Istanbul
Ege Universitesi Hastanesi ( Site 0503)
RECRUITING
Izmir
Kocaeli Üniversitesi-Hematology ( Site 0506)
RECRUITING
Kocaeli
Ondokuz Mayıs Universitesi-hematology ( Site 0507)
RECRUITING
Samsun
United Kingdom
Glan Clwyd Hospital ( Site 0528)
RECRUITING
Bodelwyddan
Boston Pilgrim Hospital ( Site 0525)
RECRUITING
Boston
Gloucestershire Royal Hospital ( Site 0521)
RECRUITING
Gloucester
Lincoln County Hospital ( Site 0535)
RECRUITING
Lincoln
Guy's & St Thomas' NHS Foundation Trust ( Site 0523)
RECRUITING
London
Hammersmith Hospital ( Site 0533)
RECRUITING
London
University College London Hospital ( Site 0527)
RECRUITING
London
Freeman Hospital ( Site 0532)
RECRUITING
Newcastle Upon Tyne
Royal Gwent Hospital ( Site 0524)
RECRUITING
Newport
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2029-04-15
Participants
Target number of participants: 300
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC