A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543/IMG-7289) Versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia Who Have an Inadequate Response to or Are Intolerant of Hydroxyurea
Status: Recruiting
Location: See all (159) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist)
• 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 a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance
• Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
• Has a platelet count \> 450 × 10\^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
• Has an absolute neutrophil count (ANC) ≥0.75 × 10\^9/L assessed up to 72 hours before first dose of study intervention
• Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea
Locations
United States
California
Los Angeles Cancer Network ( Site 3491)
RECRUITING
Glendale
Stanford Cancer Institute ( Site 0107)
RECRUITING
Stanford
The Lundquist Institute ( Site 3423)
RECRUITING
Torrance
Colorado
University of Colorado Anschutz Medical Campus ( Site 3425)
RECRUITING
Aurora
Massachusetts
Tufts Medical Center ( Site 3408)
RECRUITING
Boston
Michigan
University of Michigan ( Site 0008)
RECRUITING
Ann Arbor
Henry Ford Hospital ( Site 3413)
RECRUITING
Detroit
North Carolina
Duke University Health System (DUHS) ( Site 0016)
RECRUITING
Durham
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400)
RECRUITING
Winston-salem
New York
Roswell Park Cancer Institute ( Site 3421)
RECRUITING
Buffalo
South Carolina
Medical University of South Carolina-Hollings Cancer Center ( Site 3426)
RECRUITING
Charleston
Virginia
University of Virginia ( Site 3422)
RECRUITING
Charlottesville
VCU Health Adult Outpatient Pavillion ( Site 3416)
RECRUITING
Richmond
Other Locations
Argentina
Hospital Italiano de Buenos Aires ( Site 0105)
ACTIVE_NOT_RECRUITING
Abb
Hospital Universitario Austral ( Site 0104)
RECRUITING
Pilar
C.I.C.E. 9 de Julio ( Site 1001)
ACTIVE_NOT_RECRUITING
San Miguel De Tucumán
Australia
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001)
ACTIVE_NOT_RECRUITING
Adelaide
Royal Prince Alfred Hospital ( Site 1100)
RECRUITING
Camperdown
Monash Health-Haematology Research ( Site 0006)
RECRUITING
Clayton
Liverpool Hospital-Haematology ( Site 0501)
ACTIVE_NOT_RECRUITING
Liverpool
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0502)
RECRUITING
Melbourne
Royal Perth Hospital-Haematology ( Site 0504)
ACTIVE_NOT_RECRUITING
Perth
Royal North Shore Hospital ( Site 0003)
ACTIVE_NOT_RECRUITING
St Leonards
Calvary Mater Newcastle ( Site 0505)
ACTIVE_NOT_RECRUITING
Waratah
Belgium
ZAS Cadix ( Site 1200)
ACTIVE_NOT_RECRUITING
Antwerp
Canada
The Moncton Hospital-Oncology ( Site 1500)
RECRUITING
Moncton
China
Peking Union Medical College Hospital ( Site 3531)
RECRUITING
Beijing
Peking University Third Hospital-Hematology ( Site 3502)
RECRUITING
Beijing
The First Afflilated Hospital of Bengbu Medical College ( Site 3509)
RECRUITING
Bengbu
The First Hospital of Jilin University-Hematology ( Site 3526)
COMPLETED
Changchun
West China Hospital, Sichuan University ( Site 3518)
RECRUITING
Chengdu
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 3511)
RECRUITING
Guangzhou
Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 3524)
RECRUITING
Guangzhou
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3508)
RECRUITING
Hangzhou
Anhui Provincial Hospital ( Site 3513)
RECRUITING
Hefei
Jinan Central Hospital ( Site 3523)
RECRUITING
Jinan
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3505)
RECRUITING
Nanchang
Jiangsu Province Hospital ( Site 3507)
ACTIVE_NOT_RECRUITING
Nanjing
Affiliated Hospital of Nantong University ( Site 3527)
RECRUITING
Nantong
The Second Affiliated Hospital Of Fujian Medical University ( Site 3525)
RECRUITING
Quanzhou
Huashan Hospital, Fudan University ( Site 3529)
RECRUITING
Shanghai
Zhongshan Hospital,Fudan University-Hematology ( Site 3530)
RECRUITING
Shanghai
The First Hospital of Hebei Medical University ( Site 3510)
RECRUITING
Shijiazhuang
Institute of hematology&blood disease hospital ( Site 3501)
RECRUITING
Tianjin
Wuhan Union Hospital ( Site 3500)
RECRUITING
Wuhan
Shaanxi provincial people's hospital ( Site 3516)
RECRUITING
Xi'an
The First Affiliated hospital of Xiamen University ( Site 3515)
RECRUITING
Xiamen
Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 3517)
RECRUITING
Yiwu
Henan Cancer Hospital-hematology department ( Site 3504)
RECRUITING
Zhengzhou
Colombia
Los Cobos Medical Center ( Site 1404)
ACTIVE_NOT_RECRUITING
Bogotá
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1403)
ACTIVE_NOT_RECRUITING
Medellín
IMAT S.A.S ( Site 1401)
ACTIVE_NOT_RECRUITING
Montería
France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Hématologie Clinique et Thérapie Cellu ( Site 1701)
RECRUITING
Limoges
Hôpital Saint Antoine-Service d'Hématologie et de Thérapie Cellulaire ( Site 1702)
COMPLETED
Paris
Hôpital Saint-Louis-Centre d'Investigations Cliniques ( Site 0405)
RECRUITING
Paris
centre hospitalier lyon sud ( Site 0406)
RECRUITING
Pierre-bénite
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0417)
RECRUITING
Rennes
Centre Hospitalier de Roubaix ( Site 1703)
RECRUITING
Roubaix
Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0413)
RECRUITING
Tours
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois-HEMATOLOGY ( Site 0407)
RECRUITING
Vandœuvre-lès-nancy
Germany
Universitätsklinikum Aachen ( Site 1801)
RECRUITING
Aachen
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0402)
RECRUITING
Dresden
Universitätsklinikum Halle ( Site 0401)
RECRUITING
Halle
Hong Kong Special Administrative Region
Queen Mary Hospital ( Site 1901)
RECRUITING
Hksar
Hungary
Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 0708)
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0707)
RECRUITING
Debrecen
Petz Aladar Egyetemi Oktato Korhaz ( Site 2000)
RECRUITING
Győr
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0706)
RECRUITING
Nyíregyháza
Israel
Soroka Medical Center ( Site 2100)
ACTIVE_NOT_RECRUITING
Beersheba
Carmel Hospital ( Site 0906)
ACTIVE_NOT_RECRUITING
Haifa
Rambam Health Care Campus ( Site 2102)
ACTIVE_NOT_RECRUITING
Haifa
Hadassah Medical Center ( Site 0904)
ACTIVE_NOT_RECRUITING
Jerusalem
Rabin Medical Center ( Site 0905)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 2101)
ACTIVE_NOT_RECRUITING
Ramat Gan
Sourasky Medical Center ( Site 0902)
ACTIVE_NOT_RECRUITING
Tel Aviv
Yitzhak Shamir Medical Center. ( Site 0901)
ACTIVE_NOT_RECRUITING
Ẕerifin
Italy
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0034)
ACTIVE_NOT_RECRUITING
Alessandria
Azienda Ospedaliero Universitaria delle Marche ( Site 0302)
RECRUITING
Ancona
Istituto Oncologico Veneto IRCCS-Oncoematologia ( Site 0306)
ACTIVE_NOT_RECRUITING
Castelfranco Veneto
Azienda Ospedaliero Universitaria di Ferrara ( Site 0304)
ACTIVE_NOT_RECRUITING
Cona
Azienda Ospedaliera Universitaria Careggi ( Site 0030)
ACTIVE_NOT_RECRUITING
Florence
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori ( Site 0308)
ACTIVE_NOT_RECRUITING
Meldola
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2201)
RECRUITING
Milan
Azienda Ospedaliero Universitaria Pisana-UO Ematologia UNIV ( Site 0309)
RECRUITING
Pisa
Arcispedale Santa Maria Nuova ( Site 0301)
RECRUITING
Reggio Emilia
Ospedale Mauriziano ( Site 0305)
RECRUITING
Torino
Ospedale di Circolo e Fondazione Macchi Varese ( Site 2200)
ACTIVE_NOT_RECRUITING
Varese
Japan
Juntendo University Hospital ( Site 3611)
RECRUITING
Bunkyo-ku
Nippon Medical School Hospital ( Site 3608)
RECRUITING
Bunkyo-ku
University of Yamanashi Hospital ( Site 3606)
RECRUITING
Chūō
Kyushu University Hospital ( Site 3605)
RECRUITING
Fukuoka
Fukushima Medical University Hospital ( Site 3616)
RECRUITING
Fukushima
Kansai Medical University Hospital ( Site 3607)
RECRUITING
Hirakata
Kanazawa University Hospital ( Site 3614)
RECRUITING
Kanazawa
National Cancer Center Hospital East ( Site 3610)
RECRUITING
Kashiwa
Kobe City Medical Center General Hospital ( Site 3603)
RECRUITING
Kobe
University of Miyazaki Hospital ( Site 3609)
RECRUITING
Miyazaki
Okayama University Hospital ( Site 3604)
RECRUITING
Okayama
Hokkaido University Hospital ( Site 3601)
RECRUITING
Sapporo
Kindai University Hospital ( Site 3600)
RECRUITING
Sayama
National Hospital Organization Sendai Medical Center ( Site 3617)
RECRUITING
Sendai
Ehime University Hospital ( Site 3612)
RECRUITING
Tōon
Fujita Health University Hospital ( Site 3613)
RECRUITING
Toyoake
Mie University Hospital ( Site 3615)
RECRUITING
Tsu
Netherlands
Albert Schweitzer Ziekenhuis, locatie Dordwijk-Internal Medicine ( Site 2302)
ACTIVE_NOT_RECRUITING
Dordrecht
Martini Ziekenhuis ( Site 2300)
ACTIVE_NOT_RECRUITING
Groningen
University Medical Center Groningen ( Site 2304)
ACTIVE_NOT_RECRUITING
Groningen
Spaarne Gasthuis - Hoofddorp-Oncology ( Site 2301)
COMPLETED
Hoofddorp
New Zealand
Aotearoa Clinical Trials ( Site 0050)
ACTIVE_NOT_RECRUITING
Auckland
North Shore Hospital-Department of Haematology ( Site 0051)
ACTIVE_NOT_RECRUITING
Auckland
Poland
Pratia Onkologia Katowice ( Site 0702)
ACTIVE_NOT_RECRUITING
Katowice
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 2504)
RECRUITING
Kielce
Portugal
Unidade Local de Saude de Braga - Hospital de Braga ( Site 0415)
RECRUITING
Braga
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 2600)
RECRUITING
Lisbon
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0414)
RECRUITING
Porto
Republic of Korea
Seoul National University Bundang Hospital-Hematology ( Site 0605)
COMPLETED
Seongnam
Asan Medical Center ( Site 0603)
ACTIVE_NOT_RECRUITING
Seoul
Korea University Anam Hospital ( Site 0604)
COMPLETED
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0606)
RECRUITING
Seoul
Spain
Hospital General Universitario de Albacete ( Site 0408)
ACTIVE_NOT_RECRUITING
Albacete
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0409)
ACTIVE_NOT_RECRUITING
Badalona
HOSPITAL CLÍNIC DE BARCELONA ( Site 2800)
ACTIVE_NOT_RECRUITING
Barcelona
Hospital del Mar ( Site 2807)
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0404)
ACTIVE_NOT_RECRUITING
Barcelona
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 2801)
ACTIVE_NOT_RECRUITING
L'hospitalet Del Llobregat
Hospital Universitario 12 de Octubre ( Site 2806)
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal-Hematology ( Site 2803)
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria ( Site 0418)
ACTIVE_NOT_RECRUITING
Málaga
Hospital Costa del Sol-Hematology Service ( Site 0412)
ACTIVE_NOT_RECRUITING
Marbella
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0419)
COMPLETED
Salamanca
CHUS - Hospital Clinico Universitario ( Site 0421)
ACTIVE_NOT_RECRUITING
Santiago De Compostela
Hospital Universitario Doctor Peset ( Site 0411)
ACTIVE_NOT_RECRUITING
Valencia
Sweden
Karolinska Universitetssjukhuset Huddinge ( Site 2900)
ACTIVE_NOT_RECRUITING
Huddinge
Universitetssjukhuset Örebro ( Site 0403)
ACTIVE_NOT_RECRUITING
Örebro
Taiwan
Chang Gung Memorial Hospital- Chiayi ( Site 3102)
ACTIVE_NOT_RECRUITING
Chiayi City
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 3104)
ACTIVE_NOT_RECRUITING
Kaohsiung City
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3105)
ACTIVE_NOT_RECRUITING
Tainan City
National Taiwan University Hospital ( Site 3101)
ACTIVE_NOT_RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch ( Site 3103)
RECRUITING
Taoyuan District
Turkey
Ankara Bilkent Şehir Hastanesi ( Site 3201)
RECRUITING
Ankara
Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 3210)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-Department of Hematology ( Site 3204)
RECRUITING
Ankara
Antalya Egitim ve Arastırma Hastanesi ( Site 3207)
RECRUITING
Antalya
Trakya University Medical Faculty Hospital-Hematology ( Site 3200)
RECRUITING
Edirne
Medipol Mega Universite Hastanesi-oncology ( Site 3203)
RECRUITING
Istanbul
Ege Universitesi Hastanesi ( Site 3202)
RECRUITING
Izmir
Kocaeli Üniversitesi-Hematology ( Site 3205)
RECRUITING
Kocaeli
VM Medical Park Mersin Hastanesi ( Site 3208)
RECRUITING
Mersin
Ondokuz Mayıs Universitesi-hematology ( Site 3206)
RECRUITING
Samsun
United Kingdom
Boston Pilgrim Hospital ( Site 3301)
RECRUITING
Boston
Addenbrooke's Hospital ( Site 3303)
ACTIVE_NOT_RECRUITING
Cambridge
Gloucestershire Royal Hospital ( Site 3302)
ACTIVE_NOT_RECRUITING
Gloucester
Royal Gwent Hospital ( Site 3304)
ACTIVE_NOT_RECRUITING
Gwent
Lincoln County Hospital ( Site 3310)
ACTIVE_NOT_RECRUITING
Lincoln
Guy's & St Thomas' NHS Foundation Trust ( Site 3305)
ACTIVE_NOT_RECRUITING
London
King's College Hospital ( Site 3308)
RECRUITING
London
University College London Hospital ( Site 3300)
RECRUITING
London
The Christie NHS Foundation Trust ( Site 3307)
RECRUITING
Manchester
GenesisCare - Windsor ( Site 3309)
ACTIVE_NOT_RECRUITING
Windsor
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2023-12-31
Estimated Completion Date: 2028-08-18
Participants
Target number of participants: 340
Treatments
Experimental: Bomedemstat
Participants will begin treatment at a dose of 50 mg of bomedemstat daily. 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. All participants will be treated daily for up to 52 weeks, and are eligible for an extended treatment phase up to 156 weeks.
Active_comparator: Best Available Therapy
Each participant will receive either anagrelide, busulfan, interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b, or ruxolitinib as determined by investigator. All participants will be treated per respective approved product labels for up to 52 weeks. Participants receiving BAT for 52 weeks who stop responding to BAT are eligible to switch to bomedemstat and receive this for up to 156 weeks at the investigators discretion.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC