Език: EN EN
← Назад към резултатите
Набира участници Фаза 3 NCT06079879

A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Essential Thrombocythemia

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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).
Кой може да участва
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
Интервенции
Bomedemstat
DRUG
Anagrelide
DRUG
Busulfan
DRUG
Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b
DRUG
Ruxolitinib
DRUG
Места на провеждане 162
Argentina (3)
Hospital Italiano de Buenos Aires ( Site 0105)
ABB , Buenos Aires F.D.
Study Coordinator
Hospital Universitario Austral ( Site 0104)
Pilar , Buenos Aires
Study Coordinator
C.I.C.E. 9 de Julio ( Site 1001)
San Miguel de Tucumán , Tucumán Province
Study Coordinator
Австралия (8)
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001)
Adelaide , South Australia
ACTIVE_NOT_RECRUITING
Royal Prince Alfred Hospital ( Site 1100)
Camperdown , New South Wales
ACTIVE_NOT_RECRUITING
Monash Health-Haematology Research ( Site 0006)
Clayton , Victoria
ACTIVE_NOT_RECRUITING
Liverpool Hospital-Haematology ( Site 0501)
Liverpool , New South Wales
ACTIVE_NOT_RECRUITING
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0502)
Melbourne , Victoria
ACTIVE_NOT_RECRUITING
Royal Perth Hospital-Haematology ( Site 0504)
Perth , Western Australia
ACTIVE_NOT_RECRUITING
Royal North Shore Hospital ( Site 0003)
St Leonards , New South Wales
ACTIVE_NOT_RECRUITING
Calvary Mater Newcastle ( Site 0505)
Waratah , New South Wales
ACTIVE_NOT_RECRUITING
Белгия (1)
ZAS Cadix ( Site 1200)
Antwerp
ACTIVE_NOT_RECRUITING
Канада (1)
The Moncton Hospital-Oncology ( Site 1500)
Moncton , New Brunswick
Study Coordinator
Китай (23)
Peking University Third Hospital-Hematology ( Site 3502)
Beijing , Beijing Municipality
ACTIVE_NOT_RECRUITING
Peking Union Medical College Hospital ( Site 3531)
Beijing , Beijing Municipality
ACTIVE_NOT_RECRUITING
The First Afflilated Hospital of Bengbu Medical College ( Site 3509)
Bengbu , Anhui
ACTIVE_NOT_RECRUITING
The First Hospital of Jilin University-Hematology ( Site 3526)
Changchun , Jilin
COMPLETED
West China Hospital, Sichuan University ( Site 3518)
Chengdu , Sichuan
Study Coordinator
Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 3524)
Guangzhou , Guangdong
ACTIVE_NOT_RECRUITING
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 3511)
Guangzhou , Guangdong
ACTIVE_NOT_RECRUITING
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3508)
Hangzhou , Zhejiang
Study Coordinator
Anhui Provincial Hospital ( Site 3513)
Hefei , Anhui
ACTIVE_NOT_RECRUITING
Jinan Central Hospital ( Site 3523)
Jinan , Shandong
ACTIVE_NOT_RECRUITING
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3505)
Nanchang , Jiangxi
Study Coordinator
Jiangsu Province Hospital ( Site 3507)
Nanjing , Jiangsu
ACTIVE_NOT_RECRUITING
Affiliated Hospital of Nantong University ( Site 3527)
Nantong , Jiangsu
COMPLETED
The Second Affiliated Hospital Of Fujian Medical University ( Site 3525)
Quanzhou , Fujian
ACTIVE_NOT_RECRUITING
Zhongshan Hospital,Fudan University-Hematology ( Site 3530)
Shanghai , Shanghai Municipality
ACTIVE_NOT_RECRUITING
Huashan Hospital, Fudan University ( Site 3529)
Shanghai , Shanghai Municipality
ACTIVE_NOT_RECRUITING
The First Hospital of Hebei Medical University ( Site 3510)
Shijiazhuang , Hebei
ACTIVE_NOT_RECRUITING
Institute of hematology&blood disease hospital ( Site 3501)
Tianjin , Tianjin Municipality
ACTIVE_NOT_RECRUITING
Wuhan Union Hospital ( Site 3500)
Wuhan , Hubei
ACTIVE_NOT_RECRUITING
Shaanxi provincial people's hospital ( Site 3516)
Xi'an , Shaanxi
COMPLETED
The First Affiliated hospital of Xiamen University ( Site 3515)
Xiamen , Fujian
COMPLETED
Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 3517)
Yiwu , Zhejiang
ACTIVE_NOT_RECRUITING
Henan Cancer Hospital-hematology department ( Site 3504)
Zhengzhou , Henan
ACTIVE_NOT_RECRUITING
Colombia (3)
Los Cobos Medical Center ( Site 1404)
Bogotá , Bogota D.C.
ACTIVE_NOT_RECRUITING
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1403)
Medellín , Antioquia
ACTIVE_NOT_RECRUITING
IMAT S.A.S ( Site 1401)
Montería , Departamento de Córdoba
ACTIVE_NOT_RECRUITING
Франция (8)
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Hématologie Clinique et Thérapie Cellu ( Site 1701)
Limoges , Limousin
COMPLETED
Hôpital Saint-Louis-Centre d'Investigations Cliniques ( Site 0405)
Paris
Study Coordinator
Hôpital Saint Antoine-Service d'Hématologie et de Thérapie Cellulaire ( Site 1702)
Paris , Île-de-France Region
COMPLETED
centre hospitalier lyon sud ( Site 0406)
Pierre-Bénite , Rhone
Study Coordinator
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0417)
Rennes , Brittany Region
COMPLETED
Centre Hospitalier de Roubaix ( Site 1703)
Roubaix , Nord
COMPLETED
Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0413)
Tours , Indre-et-Loire
Study Coordinator
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois-HEMATOLOGY ( Site 0407)
Vandœuvre-lès-Nancy , Lorraine
Study Coordinator
Германия (3)
Universitätsklinikum Aachen ( Site 1801)
Aachen , North Rhine-Westphalia
Study Coordinator
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0402)
Dresden , Saxony
ACTIVE_NOT_RECRUITING
Universitätsklinikum Halle ( Site 0401)
Halle , Saxony-Anhalt
ACTIVE_NOT_RECRUITING
Hong Kong (1)
Queen Mary Hospital ( Site 1901)
Hksar
Study Coordinator
Унгария (4)
Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 0708)
Budapest
ACTIVE_NOT_RECRUITING
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0707)
Debrecen
ACTIVE_NOT_RECRUITING
Petz Aladar Egyetemi Oktato Korhaz ( Site 2000)
Győr , Győr-Moson-Sopron
ACTIVE_NOT_RECRUITING
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0706)
Nyíregyháza , Szabolcs-Szatmár-Bereg
ACTIVE_NOT_RECRUITING
Израел (8)
Soroka Medical Center ( Site 2100)
Beersheba
ACTIVE_NOT_RECRUITING
Rambam Health Care Campus ( Site 2102)
Haifa
ACTIVE_NOT_RECRUITING
Carmel Hospital ( Site 0906)
Haifa
ACTIVE_NOT_RECRUITING
Hadassah Medical Center ( Site 0904)
Jerusalem
ACTIVE_NOT_RECRUITING
Rabin Medical Center ( Site 0905)
Petah Tikva
Study Coordinator
Sheba Medical Center ( Site 2101)
Ramat Gan
ACTIVE_NOT_RECRUITING
Sourasky Medical Center ( Site 0902)
Tel Aviv
ACTIVE_NOT_RECRUITING
Yitzhak Shamir Medical Center. ( Site 0901)
Ẕerifin
ACTIVE_NOT_RECRUITING
Италия (11)
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0034)
Alessandria
ACTIVE_NOT_RECRUITING
Azienda Ospedaliero Universitaria delle Marche ( Site 0302)
Ancona
Study Coordinator
Istituto Oncologico Veneto IRCCS-Oncoematologia ( Site 0306)
Castelfranco Veneto , Veneto
ACTIVE_NOT_RECRUITING
Azienda Ospedaliero Universitaria di Ferrara ( Site 0304)
Cona , Ferrara
ACTIVE_NOT_RECRUITING
Azienda Ospedaliera Universitaria Careggi ( Site 0030)
Florence , Tuscany
ACTIVE_NOT_RECRUITING
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0308)
Meldola , Forli-Cesena
ACTIVE_NOT_RECRUITING
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2201)
Milan , Lombardy
ACTIVE_NOT_RECRUITING
Azienda Ospedaliero Universitaria Pisana-UO Ematologia UNIV ( Site 0309)
Pisa , Tuscany
COMPLETED
Arcispedale Santa Maria Nuova ( Site 0301)
Reggio Emilia
Study Coordinator
Ospedale Mauriziano ( Site 0305)
Torino
Study Coordinator
Ospedale di Circolo e Fondazione Macchi Varese ( Site 2200)
Varese
ACTIVE_NOT_RECRUITING
Япония (17)
Juntendo University Hospital ( Site 3611)
Bunkyo-ku , Tokyo
Study Coordinator
Nippon Medical School Hospital ( Site 3608)
Bunkyo-ku , Tokyo
Study Coordinator
University of Yamanashi Hospital ( Site 3606)
Chūō , Yamanashi
Study Coordinator
Kyushu University Hospital ( Site 3605)
Fukuoka
Study Coordinator
Fukushima Medical University Hospital ( Site 3616)
Fukushima
Study Coordinator
Kansai Medical University Hospital ( Site 3607)
Hirakata , Osaka
Study Coordinator
Kanazawa University Hospital ( Site 3614)
Kanazawa , Ishikawa-ken
Study Coordinator
National Cancer Center Hospital East ( Site 3610)
Kashiwa , Chiba
Study Coordinator
Kobe City Medical Center General Hospital ( Site 3603)
Kobe , Hyōgo
Study Coordinator
University of Miyazaki Hospital ( Site 3609)
Miyazaki
Study Coordinator
Okayama University Hospital ( Site 3604)
Okayama
Study Coordinator
Kindai University Hospital ( Site 3600)
Sakai , Osaka
Study Coordinator
Hokkaido University Hospital ( Site 3601)
Sapporo , Hokkaido
Study Coordinator
National Hospital Organization Sendai Medical Center ( Site 3617)
Sendai , Miyagi
Study Coordinator
Ehime University Hospital ( Site 3612)
Tōon , Ehime
Study Coordinator
Fujita Health University Hospital ( Site 3613)
Toyoake , Aichi-ken
Study Coordinator
Mie University Hospital ( Site 3615)
Tsu , Mie-ken
Study Coordinator
Нидерландия (4)
Albert Schweitzer Ziekenhuis, locatie Dordwijk-Internal Medicine ( Site 2302)
Dordrecht , South Holland
ACTIVE_NOT_RECRUITING
University Medical Center Groningen ( Site 2304)
Groningen
ACTIVE_NOT_RECRUITING
Martini Ziekenhuis ( Site 2300)
Groningen
ACTIVE_NOT_RECRUITING
Spaarne Gasthuis - Hoofddorp-Oncology ( Site 2301)
Hoofddorp , North Holland
COMPLETED
New Zealand (2)
North Shore Hospital-Department of Haematology ( Site 0051)
Auckland
ACTIVE_NOT_RECRUITING
Aotearoa Clinical Trials ( Site 0050)
Auckland
ACTIVE_NOT_RECRUITING
Полша (2)
Pratia Onkologia Katowice ( Site 0702)
Katowice , Silesian Voivodeship
ACTIVE_NOT_RECRUITING
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 2504)
Kielce , Świętokrzyskie Voivodeship
COMPLETED
Португалия (3)
Unidade Local de Saude de Braga - Hospital de Braga ( Site 0415)
Braga
Study Coordinator
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 2600)
Lisbon
Study Coordinator
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0414)
Porto
Study Coordinator
Южна Корея (4)
Seoul National University Bundang Hospital-Hematology ( Site 0605)
Seongnam , Kyonggi-do
COMPLETED
Korea University Anam Hospital ( Site 0604)
Seoul
COMPLETED
Asan Medical Center ( Site 0603)
Seoul
ACTIVE_NOT_RECRUITING
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0606)
Seoul
ACTIVE_NOT_RECRUITING
Испания (13)
Hospital General Universitario de Albacete ( Site 0408)
Albacete
ACTIVE_NOT_RECRUITING
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0409)
Badalona , Barcelona
ACTIVE_NOT_RECRUITING
Hospital del Mar ( Site 2807)
Barcelona , Catalonia
ACTIVE_NOT_RECRUITING
HOSPITAL CLÍNIC DE BARCELONA ( Site 2800)
Barcelona , Catalonia
ACTIVE_NOT_RECRUITING
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0404)
Barcelona
ACTIVE_NOT_RECRUITING
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 2801)
L'Hospitalet Del Llobregat , Barcelona
ACTIVE_NOT_RECRUITING
Hospital Universitario Ramón y Cajal-Hematology ( Site 2803)
Madrid , Madrid, Comunidad de
ACTIVE_NOT_RECRUITING
Hospital Universitario 12 de Octubre ( Site 2806)
Madrid
ACTIVE_NOT_RECRUITING
Hospital Universitario Virgen de la Victoria ( Site 0418)
Málaga
ACTIVE_NOT_RECRUITING
Hospital Costa del Sol-Hematology Service ( Site 0412)
Marbella , Malaga
ACTIVE_NOT_RECRUITING
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0419)
Salamanca
COMPLETED
CHUS - Hospital Clinico Universitario ( Site 0421)
Santiago de Compostela , La Coruna
ACTIVE_NOT_RECRUITING
Hospital Universitario Doctor Peset ( Site 0411)
Valencia
ACTIVE_NOT_RECRUITING
Швеция (2)
Karolinska Universitetssjukhuset Huddinge ( Site 2900)
Huddinge , Stockholm County
ACTIVE_NOT_RECRUITING
Universitetssjukhuset Örebro ( Site 0403)
Örebro , Örebro County
ACTIVE_NOT_RECRUITING
Taiwan (5)
Chang Gung Memorial Hospital- Chiayi ( Site 3102)
Chiayi City , Chiayi
ACTIVE_NOT_RECRUITING
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 3104)
Kaohsiung City
ACTIVE_NOT_RECRUITING
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3105)
Tainan
ACTIVE_NOT_RECRUITING
National Taiwan University Hospital ( Site 3101)
Taipei
ACTIVE_NOT_RECRUITING
Chang Gung Medical Foundation-Linkou Branch ( Site 3103)
Taoyuan District
ACTIVE_NOT_RECRUITING
Турция (10)
Hacettepe Universite Hastaneleri-Department of Hematology ( Site 3204)
Ankara
Study Coordinator
Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 3210)
Ankara
Study Coordinator
Ankara Bilkent Şehir Hastanesi ( Site 3201)
Ankara
Study Coordinator
Antalya Egitim ve Arastırma Hastanesi ( Site 3207)
Antalya
Study Coordinator
Ege Universitesi Hastanesi ( Site 3202)
Bornova , İzmir
Study Coordinator
Trakya University Medical Faculty Hospital-Hematology ( Site 3200)
Edirne
Study Coordinator
Medipol Mega Universite Hastanesi-oncology ( Site 3203)
Istanbul
Study Coordinator
Kocaeli Üniversitesi-Hematology ( Site 3205)
Kocaeli
Study Coordinator
VM Medical Park Mersin Hastanesi ( Site 3208)
Mersin
Study Coordinator
Ondokuz Mayıs Universitesi-hematology ( Site 3206)
Samsun
Study Coordinator
Великобритания (10)
Boston Pilgrim Hospital ( Site 3301)
Boston , Lincolnshire
Study Coordinator
Addenbrooke's Hospital ( Site 3303)
Cambridge , Cambridgeshire
ACTIVE_NOT_RECRUITING
Gloucestershire Royal Hospital ( Site 3302)
Gloucester , Gloucestershire
ACTIVE_NOT_RECRUITING
Royal Gwent Hospital ( Site 3304)
Gwent , Newport
ACTIVE_NOT_RECRUITING
Lincoln County Hospital ( Site 3310)
Lincoln , Great Britain
ACTIVE_NOT_RECRUITING
University College London Hospital ( Site 3300)
London , London, City of
ACTIVE_NOT_RECRUITING
Guy's & St Thomas' NHS Foundation Trust ( Site 3305)
London , London, City of
ACTIVE_NOT_RECRUITING
King's College Hospital ( Site 3308)
London , London, City of
ACTIVE_NOT_RECRUITING
The Christie NHS Foundation Trust ( Site 3307)
Manchester
ACTIVE_NOT_RECRUITING
GenesisCare - Windsor ( Site 3309)
Windsor , Windsor And Maidenhead
ACTIVE_NOT_RECRUITING
САЩ (16)
University of Michigan ( Site 0008)
Ann Arbor , Michigan
Study Coordinator
University of Colorado Anschutz Medical Campus ( Site 3425)
Aurora , Colorado
Study Coordinator
Tufts Medical Center ( Site 3408)
Boston , Massachusetts
Study Coordinator
Roswell Park Cancer Institute ( Site 3421)
Buffalo , New York
Study Coordinator
Medical University of South Carolina-Hollings Cancer Center ( Site 3426)
Charleston , South Carolina
Study Coordinator
University of Virginia ( Site 3422)
Charlottesville , Virginia
Study Coordinator
Henry Ford Hospital ( Site 3413)
Detroit , Michigan
Study Coordinator
Duke University Health System (DUHS) ( Site 0016)
Durham , North Carolina
Study Coordinator
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000)
Eugene , Oregon
Study Coordinator
Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496)
Glendale , Arizona
Study Coordinator
Los Angeles Cancer Network ( Site 3491)
Glendale , California
Study Coordinator
Optum Care Cancer Center ( Site 3497)
Las Vegas , Nevada
Study Coordinator
VCU Health Adult Outpatient Pavillion ( Site 3416)
Richmond , Virginia
Study Coordinator
Stanford Cancer Institute ( Site 0107)
Stanford , California
Study Coordinator
The Lundquist Institute ( Site 3423)
Torrance , California
Study Coordinator
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400)
Winston-Salem , North Carolina
Study Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
31.12.2023
Крайна дата
18.08.2028
Регистрационен номер
NCT06079879
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.