A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an... | NCT06079879 | Trialant

A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an... | NCT06079879 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation

History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study

Evidence at the time of Screening of increased risk of bleeding

History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder

Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496)

Glendale, Arizona 85304, United States

Los Angeles Cancer Network ( Site 3491)

Glendale, California 91206, United States

Stanford Cancer Institute ( Site 0107)

Stanford, California 94305-5826, United States

The Lundquist Institute ( Site 3423)

Torrance, California 90502, United States

University of Colorado Anschutz Medical Campus ( Site 3425)

Aurora, Colorado 80045, United States

Tufts Medical Center ( Site 3408)

Boston, Massachusetts 02111, United States

University of Michigan ( Site 0008)

Ann Arbor, Michigan 48109, United States

Henry Ford Hospital ( Site 3413)

Detroit, Michigan 48202, United States

Optum Care Cancer Center ( Site 3497)

Las Vegas, Nevada 89102, United States

Roswell Park Cancer Institute ( Site 3421)

Buffalo, New York 14263, United States

Duke University Health System (DUHS) ( Site 0016)

Durham, North Carolina 27710, United States

Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400)

Winston-Salem, North Carolina 27157, United States

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000)

Eugene, Oregon 97401, United States

Medical University of South Carolina-Hollings Cancer Center ( Site 3426)

Charleston, South Carolina 29425, United States

University of Virginia ( Site 3422)

Charlottesville, Virginia 22908, United States

VCU Health Adult Outpatient Pavillion ( Site 3416)

Richmond, Virginia 23219, United States

Hospital Universitario Austral ( Site 0104)

Pilar, Buenos Aires B1629AHJ, Argentina

Hospital Italiano de Buenos Aires ( Site 0105)

ABB, Buenos Aires F.D. C1199ABB, Argentina

C.I.C.E. 9 de Julio ( Site 1001)

San Miguel de Tucumán, Tucumán Province T4000IKO, Argentina

Royal Prince Alfred Hospital ( Site 1100)

Camperdown, New South Wales 2050, Australia

Liverpool Hospital-Haematology ( Site 0501)

Liverpool, New South Wales 2170, Australia

Royal North Shore Hospital ( Site 0003)

St Leonards, New South Wales 2065, Australia

Calvary Mater Newcastle ( Site 0505)

Waratah, New South Wales 2298, Australia

Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001)

Adelaide, South Australia 5000, Australia

Monash Health-Haematology Research ( Site 0006)

Clayton, Victoria 3168, Australia

Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0502)

Melbourne, Victoria 3021, Australia

Royal Perth Hospital-Haematology ( Site 0504)

Perth, Western Australia 6000, Australia

ZAS Cadix ( Site 1200)

Antwerp, 2030, Belgium

University Of Alberta Hospital ( Site 1504)

Edmonton, Alberta T6G 2B7, Canada

The Moncton Hospital-Oncology ( Site 1500)

Moncton, New Brunswick E1C 6Z8, Canada

The First Afflilated Hospital of Bengbu Medical College ( Site 3509)

Bengbu, Anhui 233004, China

Anhui Provincial Hospital ( Site 3513)

Hefei, Anhui 230071, China

Peking University Third Hospital-Hematology ( Site 3502)

Beijing, Beijing Municipality 100191, China

Peking Union Medical College Hospital ( Site 3531)

Beijing, Beijing Municipality 100730, China

The Second Affiliated Hospital Of Fujian Medical University ( Site 3525)

Quanzhou, Fujian 362000, China

The First Affiliated hospital of Xiamen University ( Site 3515)

Xiamen, Fujian 361003, China

Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 3524)

Guangzhou, Guangdong 510120, China

Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 3511)

Guangzhou, Guangdong 510515, China

The First Hospital of Hebei Medical University ( Site 3510)

Shijiazhuang, Hebei 050031, China

Henan Cancer Hospital-hematology department ( Site 3504)

Zhengzhou, Henan 450008, China

Wuhan Union Hospital ( Site 3500)

Wuhan, Hubei 430022, China

Jiangsu Province Hospital ( Site 3507)

Nanjing, Jiangsu 210029, China

Affiliated Hospital of Nantong University ( Site 3527)

Nantong, Jiangsu 226001, China

The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3505)

Nanchang, Jiangxi 330209, China

The First Hospital of Jilin University-Hematology ( Site 3526)

Changchun, Jilin 130021, China

Shaanxi provincial people's hospital ( Site 3516)

Xi'an, Shaanxi 710068, China

Jinan Central Hospital ( Site 3523)

Jinan, Shandong 250013, China

Zhongshan Hospital,Fudan University-Hematology ( Site 3530)

Shanghai, Shanghai Municipality 200032, China

Huashan Hospital, Fudan University ( Site 3529)

Shanghai, Shanghai Municipality 200040, China

West China Hospital, Sichuan University ( Site 3518)

Chengdu, Sichuan 610041, China

Institute of hematology&blood disease hospital ( Site 3501)

Tianjin, Tianjin Municipality 300020, China

The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3508)

Hangzhou, Zhejiang 310006, China

Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 3517)

Yiwu, Zhejiang 322000, China

Fundacion Colombiana de Cancerología Clinica Vida ( Site 1403)

Medellín, Antioquia 050030, Colombia

Los Cobos Medical Center ( Site 1404)

Bogotá, Bogota D.C. 110121, Colombia

IMAT S.A.S ( Site 1401)

Montería, Departamento de Córdoba 230002, Colombia

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0417)

Rennes, Brittany Region 35000, France

Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0413)

Tours, Indre-et-Loire 37000, France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Hématologie Clinique et Thérapie Cellu ( Site 1701)

Limoges, Limousin 87042, France

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois-HEMATOLOGY ( Site 0407)

Vandœuvre-lès-Nancy, Lorraine 54511, France

Centre Hospitalier de Roubaix ( Site 1703)

Roubaix, Nord 59100, France

centre hospitalier lyon sud ( Site 0406)

Pierre-Bénite, Rhone 69310, France

Hôpital Saint-Louis-Centre d'Investigations Cliniques ( Site 0405)

Paris, 75010, France

Hôpital Saint Antoine-Service d'Hématologie et de Thérapie Cellulaire ( Site 1702)

Paris, Île-de-France Region 75571, France

Universitätsklinikum Aachen ( Site 1801)

Aachen, North Rhine-Westphalia 52074, Germany

Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0402)

Dresden, Saxony 01307, Germany

Universitätsklinikum Halle ( Site 0401)

Halle, Saxony-Anhalt 06120, Germany

Queen Mary Hospital ( Site 1901)

Hksar, Hong Kong

Petz Aladar Egyetemi Oktato Korhaz ( Site 2000)

Győr, Győr-Moson-Sopron, Hungary

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0706)

Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary

Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 0708)

Budapest, 1088, Hungary

Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0707)

Debrecen, 4032, Hungary

Soroka Medical Center ( Site 2100)

Beersheba, 8410101, Israel

Rambam Health Care Campus ( Site 2102)

Haifa, 3109601, Israel

Carmel Hospital ( Site 0906)

Haifa, 3436212, Israel

Hadassah Medical Center ( Site 0904)

Jerusalem, 9112001, Israel

Rabin Medical Center ( Site 0905)

Petah Tikva, 4941492, Israel

Sheba Medical Center ( Site 2101)

Ramat Gan, 5265601, Israel

Sourasky Medical Center ( Site 0902)

Tel Aviv, 6423906, Israel

Yitzhak Shamir Medical Center. ( Site 0901)

Ẕerifin, 7033001, Israel

Azienda Ospedaliero Universitaria di Ferrara ( Site 0304)

Cona, Ferrara 44124, Italy

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0308)

Meldola, Forli-Cesena 47014, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2201)

Milan, Lombardy 20122, Italy

Azienda Ospedaliera Universitaria Careggi ( Site 0030)

Florence, Tuscany 50134, Italy

Azienda Ospedaliero Universitaria Pisana-UO Ematologia UNIV ( Site 0309)

Pisa, Tuscany 56126, Italy

Istituto Oncologico Veneto IRCCS-Oncoematologia ( Site 0306)

Castelfranco Veneto, Veneto 31033, Italy

Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0034)

Alessandria, 15121, Italy

Azienda Ospedaliero Universitaria delle Marche ( Site 0302)

Ancona, 60126, Italy

Arcispedale Santa Maria Nuova ( Site 0301)

Reggio Emilia, 42123, Italy

Ospedale Mauriziano ( Site 0305)

Torino, 10128, Italy

Ospedale di Circolo e Fondazione Macchi Varese ( Site 2200)

Varese, 21100, Italy

Fujita Health University Hospital ( Site 3613)

Toyoake, Aichi-ken 470-1192, Japan

National Cancer Center Hospital East ( Site 3610)

Kashiwa, Chiba 277-8577, Japan

Ehime University Hospital ( Site 3612)

Tōon, Ehime 791-0295, Japan

Hokkaido University Hospital ( Site 3601)

Sapporo, Hokkaido 060-8648, Japan

Kobe City Medical Center General Hospital ( Site 3603)

Kobe, Hyōgo 650-0047, Japan

Kanazawa University Hospital ( Site 3614)

Kanazawa, Ishikawa-ken 920-8641, Japan

Mie University Hospital ( Site 3615)

Tsu, Mie-ken 514-8507, Japan

National Hospital Organization Sendai Medical Center ( Site 3617)

Sendai, Miyagi 983-8520, Japan

Kansai Medical University Hospital ( Site 3607)

Hirakata, Osaka 573-1191, Japan

Kindai University Hospital ( Site 3600)

Sakai, Osaka 590-0197, Japan

Juntendo University Hospital ( Site 3611)

Bunkyo-ku, Tokyo 113-8431, Japan

Nippon Medical School Hospital ( Site 3608)

Bunkyo-ku, Tokyo 113-8603, Japan

University of Yamanashi Hospital ( Site 3606)

Chūō, Yamanashi 409-3898, Japan

Kyushu University Hospital ( Site 3605)

Fukuoka, 812-8582, Japan

Fukushima Medical University Hospital ( Site 3616)

Fukushima, 960-1295, Japan

University of Miyazaki Hospital ( Site 3609)

Miyazaki, 889-1692, Japan

Okayama University Hospital ( Site 3604)

Okayama, 700-8558, Japan

Spaarne Gasthuis - Hoofddorp-Oncology ( Site 2301)

Hoofddorp, North Holland 2134 TM, Netherlands

Albert Schweitzer Ziekenhuis, locatie Dordwijk-Internal Medicine ( Site 2302)

Dordrecht, South Holland 3318 AT, Netherlands

University Medical Center Groningen ( Site 2304)

Groningen, 9713 GZ, Netherlands

Martini Ziekenhuis ( Site 2300)

Groningen, 9728 NT, Netherlands

North Shore Hospital-Department of Haematology ( Site 0051)

Auckland, 0622, New Zealand

Aotearoa Clinical Trials ( Site 0050)

Auckland, 2025, New Zealand

Pratia Onkologia Katowice ( Site 0702)

Katowice, Silesian Voivodeship 40-519, Poland

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 2504)

Kielce, Świętokrzyskie Voivodeship 25-734, Poland

Unidade Local de Saude de Braga - Hospital de Braga ( Site 0415)

Braga, 4710-243, Portugal

Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 2600)

Lisbon, 1449-005, Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0414)

Porto, 4200-072, Portugal

Seoul National University Bundang Hospital-Hematology ( Site 0605)

Seongnam, Kyonggi-do 13620, South Korea

Korea University Anam Hospital ( Site 0604)

Seoul, 02841, South Korea

Asan Medical Center ( Site 0603)

Seoul, 05505, South Korea

The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0606)

Seoul, 06591, South Korea

Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0409)

Badalona, Barcelona 08916, Spain

Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 2801)

L'Hospitalet Del Llobregat, Barcelona 08908, Spain

Hospital del Mar ( Site 2807)

Barcelona, Catalonia 08003, Spain

HOSPITAL CLÍNIC DE BARCELONA ( Site 2800)

Barcelona, Catalonia 08036, Spain

CHUS - Hospital Clinico Universitario ( Site 0421)

Santiago de Compostela, La Coruna 19706, Spain

Hospital Universitario Ramón y Cajal-Hematology ( Site 2803)

Madrid, Madrid, Comunidad de 28034, Spain

Hospital Costa del Sol-Hematology Service ( Site 0412)

Marbella, Malaga 29603, Spain

Hospital General Universitario de Albacete ( Site 0408)

Albacete, 02006, Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0404)

Barcelona, 08035, Spain

Hospital Universitario 12 de Octubre ( Site 2806)

Madrid, 28041, Spain

Hospital Universitario Virgen de la Victoria ( Site 0418)

Málaga, 29010, Spain

Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0419)

Salamanca, 37007, Spain

Hospital Universitario Doctor Peset ( Site 0411)

Valencia, 46017, Spain

Karolinska Universitetssjukhuset Huddinge ( Site 2900)

Huddinge, Stockholm County 141 86, Sweden

Universitetssjukhuset Örebro ( Site 0403)

Örebro, Örebro County 701 85, Sweden

Chang Gung Memorial Hospital- Chiayi ( Site 3102)

Chiayi City, Chiayi 613, Taiwan

Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 3104)

Kaohsiung City, 83301, Taiwan

National Cheng Kung University Hospital-Clinical Trial Center ( Site 3105)

Tainan, 704, Taiwan

National Taiwan University Hospital ( Site 3101)

Taipei, 10048, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 3103)

Taoyuan, 33305, Taiwan

Ege Universitesi Hastanesi ( Site 3202)

Bornova, İzmir 35100, Turkey (Türkiye)

Hacettepe Universite Hastaneleri-Department of Hematology ( Site 3204)

Ankara, 06230, Turkey (Türkiye)

Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 3210)

Ankara, 06620, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi ( Site 3201)

Ankara, 06800, Turkey (Türkiye)

Antalya Egitim ve Arastırma Hastanesi ( Site 3207)

Antalya, 07100, Turkey (Türkiye)

Trakya University Medical Faculty Hospital-Hematology ( Site 3200)

Edirne, 22030, Turkey (Türkiye)

Medipol Mega Universite Hastanesi-oncology ( Site 3203)

Istanbul, 34214, Turkey (Türkiye)

Kocaeli Üniversitesi-Hematology ( Site 3205)

Kocaeli, 41380, Turkey (Türkiye)

VM Medical Park Mersin Hastanesi ( Site 3208)

Mersin, 33440, Turkey (Türkiye)

Ondokuz Mayıs Universitesi-hematology ( Site 3206)

Samsun, 55270, Turkey (Türkiye)

Addenbrooke's Hospital ( Site 3303)

Cambridge, Cambridgeshire CB2 2QQ, United Kingdom

Gloucestershire Royal Hospital ( Site 3302)

Gloucester, Gloucestershire Gl1 3NN, United Kingdom

Lincoln County Hospital ( Site 3310)

Lincoln, Great Britain LN2 5QY, United Kingdom

Boston Pilgrim Hospital ( Site 3301)

Boston, Lincolnshire PE21 9QS, United Kingdom

University College London Hospital ( Site 3300)

London, London, City of NW1 2PG, United Kingdom

Guy's & St Thomas' NHS Foundation Trust ( Site 3305)

London, London, City of SE1 9RT, United Kingdom

King's College Hospital ( Site 3308)

London, London, City of SE5 9RS, United Kingdom

Royal Gwent Hospital ( Site 3304)

Gwent, Newport NP20 2UB, United Kingdom

GenesisCare - Windsor ( Site 3309)

Windsor, Windsor And Maidenhead SL4 3HD, United Kingdom

The Christie NHS Foundation Trust ( Site 3307)

Manchester, m20 4bx, United Kingdom