En undersøgelse af Bomedemstat (IMG-7289/MK-3543) sammenlignet med bedste tilgængelige terapi (BAT) hos deltagere med essentiel trombocytæmi og en utilstrækkelig respons eller intolerance over for Hydroxyurea (MK-3543-006)
11. august 2026 opdateret af: Merck Sharp & Dohme LLC
En fase 3, randomiseret, åben-label, aktiv-komparator-kontrolleret klinisk undersøgelse til evaluering af sikkerheden og effektiviteten af Bomedemstat (MK-3543/IMG-7289) versus bedste tilgængelige terapi (BAT) hos deltagere med essentiel trombocytæmi, der har en utilstrækkelig Reaktion på eller er intolerant over for Hydroxyurea
Dette er en undersøgelse, der evaluerer sikkerheden og effektiviteten af bomedemstat (MK-3543) sammenlignet med den bedste tilgængelige behandling (BAT) hos deltagere med essentiel trombocytæmi (ET), som har en utilstrækkelig respons på eller er intolerante over for hydroxyurinstof.
Den primære undersøgelseshypotese er, at bomedemstat er overlegen i forhold til den bedst tilgængelige behandling med hensyn til varig klinisk hæmatologisk respons (DCHR).
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
340
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires
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Pilar, Buenos Aires, Argentina, B1629AHJ
- Hospital Universitario Austral ( Site 0104)
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Buenos Aires F.D.
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ABB, Buenos Aires F.D., Argentina, C1199ABB
- Hospital Italiano de Buenos Aires ( Site 0105)
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000IKO
- C.I.C.E. 9 de Julio ( Site 1001)
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New South Wales
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Camperdown, New South Wales, Australien, 2050
- Royal Prince Alfred Hospital ( Site 1100)
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Liverpool, New South Wales, Australien, 2170
- Liverpool Hospital-Haematology ( Site 0501)
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St Leonards, New South Wales, Australien, 2065
- Royal North Shore Hospital ( Site 0003)
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Waratah, New South Wales, Australien, 2298
- Calvary Mater Newcastle ( Site 0505)
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South Australia
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Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001)
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Victoria
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Clayton, Victoria, Australien, 3168
- Monash Health-Haematology Research ( Site 0006)
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Melbourne, Victoria, Australien, 3021
- Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0502)
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Western Australia
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Perth, Western Australia, Australien, 6000
- Royal Perth Hospital-Haematology ( Site 0504)
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Antwerp, Belgien, 2030
- ZAS Cadix ( Site 1200)
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- University Of Alberta Hospital ( Site 1504)
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
- The Moncton Hospital-Oncology ( Site 1500)
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Antioquia
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Medellín, Antioquia, Colombia, 050030
- Fundacion Colombiana de Cancerología Clinica Vida ( Site 1403)
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 110121
- Los Cobos Medical Center ( Site 1404)
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Departamento de Córdoba
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Montería, Departamento de Córdoba, Colombia, 230002
- IMAT S.A.S ( Site 1401)
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Manchester, Det Forenede Kongerige, m20 4bx
- The Christie NHS Foundation Trust ( Site 3307)
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Cambridgeshire
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Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 2QQ
- Addenbrooke's Hospital ( Site 3303)
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Gloucestershire
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Gloucester, Gloucestershire, Det Forenede Kongerige, Gl1 3NN
- Gloucestershire Royal Hospital ( Site 3302)
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Great Britain
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Lincoln, Great Britain, Det Forenede Kongerige, LN2 5QY
- Lincoln County Hospital ( Site 3310)
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Lincolnshire
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Boston, Lincolnshire, Det Forenede Kongerige, PE21 9QS
- Boston Pilgrim Hospital ( Site 3301)
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London, City of
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London, London, City of, Det Forenede Kongerige, NW1 2PG
- University College London Hospital ( Site 3300)
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London, London, City of, Det Forenede Kongerige, SE1 9RT
- Guy's & St Thomas' NHS Foundation Trust ( Site 3305)
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London, London, City of, Det Forenede Kongerige, SE5 9RS
- King's College Hospital ( Site 3308)
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Newport
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Gwent, Newport, Det Forenede Kongerige, NP20 2UB
- Royal Gwent Hospital ( Site 3304)
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Windsor And Maidenhead
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Windsor, Windsor And Maidenhead, Det Forenede Kongerige, SL4 3HD
- GenesisCare - Windsor ( Site 3309)
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Arizona
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Glendale, Arizona, Forenede Stater, 85304
- Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496)
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California
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Glendale, California, Forenede Stater, 91206
- Los Angeles Cancer Network ( Site 3491)
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Stanford, California, Forenede Stater, 94305-5826
- Stanford Cancer Institute ( Site 0107)
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Torrance, California, Forenede Stater, 90502
- The Lundquist Institute ( Site 3423)
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Anschutz Medical Campus ( Site 3425)
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Tufts Medical Center ( Site 3408)
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan ( Site 0008)
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital ( Site 3413)
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- Optum Care Cancer Center ( Site 3497)
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New York
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Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute ( Site 3421)
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Health System (DUHS) ( Site 0016)
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400)
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000)
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina-Hollings Cancer Center ( Site 3426)
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia ( Site 3422)
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Richmond, Virginia, Forenede Stater, 23219
- VCU Health Adult Outpatient Pavillion ( Site 3416)
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-
-
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Paris, Frankrig, 75010
- Hôpital Saint-Louis-Centre d'Investigations Cliniques ( Site 0405)
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Brittany Region
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Rennes, Brittany Region, Frankrig, 35000
- Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0417)
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Indre-et-Loire
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Tours, Indre-et-Loire, Frankrig, 37000
- Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0413)
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Limousin
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Limoges, Limousin, Frankrig, 87042
- Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Hématologie Clinique et Thérapie Cellu ( Site 1701)
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Lorraine
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Vandœuvre-lès-Nancy, Lorraine, Frankrig, 54511
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois-HEMATOLOGY ( Site 0407)
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Nord
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Roubaix, Nord, Frankrig, 59100
- Centre Hospitalier de Roubaix ( Site 1703)
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Rhone
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Pierre-Bénite, Rhone, Frankrig, 69310
- centre hospitalier lyon sud ( Site 0406)
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Île-de-France Region
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Paris, Île-de-France Region, Frankrig, 75571
- Hôpital Saint Antoine-Service d'Hématologie et de Thérapie Cellulaire ( Site 1702)
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-
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Groningen, Holland, 9713 GZ
- University Medical Center Groningen ( Site 2304)
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Groningen, Holland, 9728 NT
- Martini Ziekenhuis ( Site 2300)
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North Holland
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Hoofddorp, North Holland, Holland, 2134 TM
- Spaarne Gasthuis - Hoofddorp-Oncology ( Site 2301)
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South Holland
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Dordrecht, South Holland, Holland, 3318 AT
- Albert Schweitzer Ziekenhuis, locatie Dordwijk-Internal Medicine ( Site 2302)
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Hksar, Hong Kong
- Queen Mary Hospital ( Site 1901)
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-
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Beersheba, Israel, 8410101
- Soroka Medical Center ( Site 2100)
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Haifa, Israel, 3109601
- Rambam Health Care Campus ( Site 2102)
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Haifa, Israel, 3436212
- Carmel Hospital ( Site 0906)
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Jerusalem, Israel, 9112001
- Hadassah Medical Center ( Site 0904)
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Petah Tikva, Israel, 4941492
- Rabin Medical Center ( Site 0905)
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Ramat Gan, Israel, 5265601
- Sheba Medical Center ( Site 2101)
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center ( Site 0902)
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Ẕerifin, Israel, 7033001
- Yitzhak Shamir Medical Center. ( Site 0901)
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Alessandria, Italien, 15121
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0034)
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Ancona, Italien, 60126
- Azienda Ospedaliero Universitaria delle Marche ( Site 0302)
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Reggio Emilia, Italien, 42123
- Arcispedale Santa Maria Nuova ( Site 0301)
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Torino, Italien, 10128
- Ospedale Mauriziano ( Site 0305)
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Varese, Italien, 21100
- Ospedale di Circolo e Fondazione Macchi Varese ( Site 2200)
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Ferrara
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Cona, Ferrara, Italien, 44124
- Azienda Ospedaliero Universitaria di Ferrara ( Site 0304)
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Forli-Cesena
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Meldola, Forli-Cesena, Italien, 47014
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0308)
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Lombardy
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Milan, Lombardy, Italien, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2201)
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Tuscany
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Florence, Tuscany, Italien, 50134
- Azienda Ospedaliera Universitaria Careggi ( Site 0030)
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Pisa, Tuscany, Italien, 56126
- Azienda Ospedaliero Universitaria Pisana-UO Ematologia UNIV ( Site 0309)
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Veneto
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Castelfranco Veneto, Veneto, Italien, 31033
- Istituto Oncologico Veneto IRCCS-Oncoematologia ( Site 0306)
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Fukuoka, Japan, 812-8582
- Kyushu University Hospital ( Site 3605)
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Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital ( Site 3616)
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Miyazaki, Japan, 889-1692
- University of Miyazaki Hospital ( Site 3609)
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Okayama, Japan, 700-8558
- Okayama University Hospital ( Site 3604)
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Aichi-ken
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Toyoake, Aichi-ken, Japan, 470-1192
- Fujita Health University Hospital ( Site 3613)
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center Hospital East ( Site 3610)
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Ehime
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Tōon, Ehime, Japan, 791-0295
- Ehime University Hospital ( Site 3612)
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital ( Site 3601)
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0047
- Kobe City Medical Center General Hospital ( Site 3603)
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japan, 920-8641
- Kanazawa University Hospital ( Site 3614)
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Mie-ken
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Tsu, Mie-ken, Japan, 514-8507
- Mie University Hospital ( Site 3615)
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Miyagi
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Sendai, Miyagi, Japan, 983-8520
- National Hospital Organization Sendai Medical Center ( Site 3617)
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Osaka
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Hirakata, Osaka, Japan, 573-1191
- Kansai Medical University Hospital ( Site 3607)
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Sakai, Osaka, Japan, 590-0197
- Kindai University Hospital ( Site 3600)
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital ( Site 3611)
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Bunkyo-ku, Tokyo, Japan, 113-8603
- Nippon Medical School Hospital ( Site 3608)
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Yamanashi
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Chūō, Yamanashi, Japan, 409-3898
- University of Yamanashi Hospital ( Site 3606)
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Anhui
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Bengbu, Anhui, Kina, 233004
- The First Afflilated Hospital of Bengbu Medical College ( Site 3509)
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Hefei, Anhui, Kina, 230071
- Anhui Provincial Hospital ( Site 3513)
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100191
- Peking University Third Hospital-Hematology ( Site 3502)
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Beijing, Beijing Municipality, Kina, 100730
- Peking Union Medical College Hospital ( Site 3531)
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Fujian
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Quanzhou, Fujian, Kina, 362000
- The Second Affiliated Hospital Of Fujian Medical University ( Site 3525)
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Xiamen, Fujian, Kina, 361003
- The First Affiliated hospital of Xiamen University ( Site 3515)
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Guangdong
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Guangzhou, Guangdong, Kina, 510120
- Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 3524)
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Guangzhou, Guangdong, Kina, 510515
- Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 3511)
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Hebei
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Shijiazhuang, Hebei, Kina, 050031
- The First Hospital of Hebei Medical University ( Site 3510)
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Henan
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Zhengzhou, Henan, Kina, 450008
- Henan Cancer Hospital-hematology department ( Site 3504)
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Hubei
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Wuhan, Hubei, Kina, 430022
- Wuhan Union Hospital ( Site 3500)
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Jiangsu
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Nanjing, Jiangsu, Kina, 210029
- Jiangsu Province Hospital ( Site 3507)
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Nantong, Jiangsu, Kina, 226001
- Affiliated Hospital of Nantong University ( Site 3527)
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Jiangxi
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Nanchang, Jiangxi, Kina, 330209
- The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3505)
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Jilin
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Changchun, Jilin, Kina, 130021
- The First Hospital of Jilin University-Hematology ( Site 3526)
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Shaanxi
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Xi'an, Shaanxi, Kina, 710068
- Shaanxi provincial people's hospital ( Site 3516)
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Shandong
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Jinan, Shandong, Kina, 250013
- Jinan Central Hospital ( Site 3523)
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Zhongshan Hospital,Fudan University-Hematology ( Site 3530)
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Shanghai, Shanghai Municipality, Kina, 200040
- Huashan Hospital, Fudan University ( Site 3529)
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- West China Hospital, Sichuan University ( Site 3518)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300020
- Institute of hematology&blood disease hospital ( Site 3501)
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310006
- The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3508)
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Yiwu, Zhejiang, Kina, 322000
- Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 3517)
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Auckland, New Zealand, 0622
- North Shore Hospital-Department of Haematology ( Site 0051)
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Auckland, New Zealand, 2025
- Aotearoa Clinical Trials ( Site 0050)
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polen, 40-519
- Pratia Onkologia Katowice ( Site 0702)
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Świętokrzyskie Voivodeship
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Kielce, Świętokrzyskie Voivodeship, Polen, 25-734
- Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 2504)
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Braga, Portugal, 4710-243
- Unidade Local de Saude de Braga - Hospital de Braga ( Site 0415)
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Lisbon, Portugal, 1449-005
- Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 2600)
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Porto, Portugal, 4200-072
- Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0414)
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Albacete, Spanien, 02006
- Hospital General Universitario de Albacete ( Site 0408)
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Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0404)
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre ( Site 2806)
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Málaga, Spanien, 29010
- Hospital Universitario Virgen de la Victoria ( Site 0418)
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Salamanca, Spanien, 37007
- Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0419)
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Valencia, Spanien, 46017
- Hospital Universitario Doctor Peset ( Site 0411)
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Barcelona
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Badalona, Barcelona, Spanien, 08916
- Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0409)
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L'Hospitalet Del Llobregat, Barcelona, Spanien, 08908
- Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 2801)
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Catalonia
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Barcelona, Catalonia, Spanien, 08003
- Hospital del Mar ( Site 2807)
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Barcelona, Catalonia, Spanien, 08036
- HOSPITAL CLÍNIC DE BARCELONA ( Site 2800)
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La Coruna
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Santiago de Compostela, La Coruna, Spanien, 19706
- CHUS - Hospital Clinico Universitario ( Site 0421)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spanien, 28034
- Hospital Universitario Ramón y Cajal-Hematology ( Site 2803)
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Malaga
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Marbella, Malaga, Spanien, 29603
- Hospital Costa del Sol-Hematology Service ( Site 0412)
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Stockholm County
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Huddinge, Stockholm County, Sverige, 141 86
- Karolinska Universitetssjukhuset Huddinge ( Site 2900)
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Örebro County
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Örebro, Örebro County, Sverige, 701 85
- Universitetssjukhuset Örebro ( Site 0403)
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-
-
-
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Seoul, Sydkorea, 02841
- Korea University Anam Hospital ( Site 0604)
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Seoul, Sydkorea, 05505
- Asan Medical Center ( Site 0603)
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Seoul, Sydkorea, 06591
- The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0606)
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Kyonggi-do
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Seongnam, Kyonggi-do, Sydkorea, 13620
- Seoul National University Bundang Hospital-Hematology ( Site 0605)
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-
-
-
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Kaohsiung City, Taiwan, 83301
- Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 3104)
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital-Clinical Trial Center ( Site 3105)
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Taipei, Taiwan, 10048
- National Taiwan University Hospital ( Site 3101)
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Taoyuan, Taiwan, 33305
- Chang Gung Medical Foundation-Linkou Branch ( Site 3103)
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-
Chiayi
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Chiayi City, Chiayi, Taiwan, 613
- Chang Gung Memorial Hospital- Chiayi ( Site 3102)
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-
-
-
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Ankara, Tyrkiet (Türkiye), 06230
- Hacettepe Universite Hastaneleri-Department of Hematology ( Site 3204)
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Ankara, Tyrkiet (Türkiye), 06620
- Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 3210)
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Ankara, Tyrkiet (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi ( Site 3201)
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Antalya, Tyrkiet (Türkiye), 07100
- Antalya Egitim ve Arastırma Hastanesi ( Site 3207)
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Edirne, Tyrkiet (Türkiye), 22030
- Trakya University Medical Faculty Hospital-Hematology ( Site 3200)
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Istanbul, Tyrkiet (Türkiye), 34214
- Medipol Mega Universite Hastanesi-oncology ( Site 3203)
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Kocaeli, Tyrkiet (Türkiye), 41380
- Kocaeli Üniversitesi-Hematology ( Site 3205)
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Mersin, Tyrkiet (Türkiye), 33440
- VM Medical Park Mersin Hastanesi ( Site 3208)
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Samsun, Tyrkiet (Türkiye), 55270
- Ondokuz Mayıs Universitesi-hematology ( Site 3206)
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İzmir
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Bornova, İzmir, Tyrkiet (Türkiye), 35100
- Ege Universitesi Hastanesi ( Site 3202)
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-
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North Rhine-Westphalia
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Aachen, North Rhine-Westphalia, Tyskland, 52074
- Universitätsklinikum Aachen ( Site 1801)
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Saxony
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Dresden, Saxony, Tyskland, 01307
- Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0402)
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Tyskland, 06120
- Universitätsklinikum Halle ( Site 0401)
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-
-
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Budapest, Ungarn, 1088
- Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 0708)
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Debrecen, Ungarn, 4032
- Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0707)
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Győr-Moson-Sopron
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Győr, Győr-Moson-Sopron, Ungarn
- Petz Aladar Egyetemi Oktato Korhaz ( Site 2000)
-
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Szabolcs-Szatmár-Bereg
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Ungarn, 4400
- Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0706)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Har en diagnose på ET i henhold til WHO 2016 diagnostiske kriterier for myeloproliferative neoplasmer
- Har en knoglemarvsfibrose-score på grad 0 eller grad 1 i henhold til en ændret version af de europæiske konsensuskriterier for graduering af myelofibrose
- Har en historie med utilstrækkelig respons på eller intolerance over for hydroxyurinstof i henhold til mindst 1 af følgende kriterier, baseret på modificerede European LeukemiaNet (ELN) kriterier for hydroxyurinstofresistens eller intolerance: hydroxyurinstofresistens (eller utilstrækkelig respons) eller hydroxyurinstofintolerance
- Har en utilstrækkelig eller tab af respons på deres seneste tidligere ET-behandling, hvilket kræver en ændring af cytoreduktiv terapi
- Har et blodpladetal > 450 × 109/L (450k/μL) vurderet op til 72 timer før første dosis af undersøgelsesintervention
- Har et absolut neutrofiltal (ANC) ≥0,75 × 109/L vurderet op til 72 timer før første dosis af undersøgelsesintervention
- Har en forventet levetid på >52 uger
- Hvis deltageren er i stand til at producere sæd, accepterer deltageren ikke at donere sæd og enten afholde sig fra heteroseksuelt samleje eller bruge en yderst effektiv præventionsmetode i hele undersøgelsesperioden og i mindst den tid, der er nødvendig for at eliminere hver undersøgelsesintervention efter den sidste dosis
- Deltagere, der tildeles kvindeligt køn ved fødslen, er berettiget til at deltage, hvis de ikke er gravide eller ammer, og mindst én af følgende betingelser gælder: ikke deltager i den fødedygtige alder (POCBP) eller er POCBP og bruger en yderst effektiv præventionsmetode eller er afholdende fra penis-vaginalt samleje i undersøgelsesperioden og i mindst den tid, der er nødvendig for at eliminere hver undersøgelsesintervention efter den sidste dosis
Ekskluderingskriterier:
- Kendt øjeblikkelig eller forsinket overfølsomhedsreaktion eller idiosynkrasi over for lægemidler, der er kemisk relateret til bomedemstat eller lysindemethylase eller monoaminoxidasehæmmer (LSDi eller MAOi), som kontraindikerer deltagelse
- Anamnese med enhver sygdom/svækkelse af GI-funktion, der kan interferere med lægemiddelabsorption (f.eks. kronisk diarré eller historie med gastrisk bypass-kirurgi), forvirrer undersøgelsesresultaterne eller udgør en yderligere risiko for individet ved deltagelse i undersøgelsen
- Beviser på tidspunktet for screening af øget risiko for blødning
- Anamnese med en malignitet, medmindre potentielt helbredende behandling er afsluttet uden tegn på malignitet i 2 år. Bemærk: Tidskravet gælder ikke for deltagere, som har gennemgået en vellykket endelig resektion af basalcellekarcinom i huden, pladecellecarcinom i huden eller carcinoma in situ, undtagen carcinom in situ i blæren
- Human immundefektvirus (HIV)-inficerede deltagere med en historie med Kaposis sarkom og/eller multicentrisk Castlemans sygdom
- Brug af forbudt medicin inden for 14 dage efter første dosis af undersøgelsesintervention (f.eks. alle hæmatopoietiske vækstfaktorer, MAO-hæmmere, stærke hæmmere og inducere af CYP3A4 eller CYP2D6, lægemidler såsom chloroquin, hvis metabolitter er kendt for at hæmme CYP3A4 eller CYP2D6, såsom klasse 1-antimedicin som propafenon, der vides at forårsage trombocytopenier osv.) eller forventes at kræve nogen af disse medikamenter under undersøgelsesbehandlingen
- Har modtaget tidligere behandling for deres ET inden for 1 uge (4 uger for interferon) før første dosis af undersøgelsesintervention
- Har tidligere fået behandling med bomedemstat
- Har modtaget et forsøgsmiddel eller har brugt et forsøgsudstyr inden for 4 uger før administration af undersøgelsesintervention
- Har en aktiv infektion, der kræver systemisk terapi
- Har haft større kirurgisk indgreb ≤4 uger før første dosis af undersøgelsesintervention eller er ikke kommet sig over bivirkninger fra større kirurgisk indgreb >4 uger før første dosis
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 an additional 156 weeks.
|
Oral kapsel
Andre navne:
|
|
Aktiv komparator: 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 investigator's discretion.
|
Oral kapsel
Oral tablet
Oral tablet
Subkutan opløsning
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Durable Clinicohematologic Response (DCHR) Rate
Tidsramme: Up to approximately 52 weeks
|
DCHR rate is the percentage of participants with DCHR, defined as a confirmed reduction of platelet count to ≤400 × 10^9/L and absence of white blood cell (WBC) count elevation to >10 × 10^9/L locally assessed to be due to ET, starting by Week 24 and maintained for at least 24 weeks, and the absence of any thrombotic or major hemorrhagic events or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) by Week 52.
|
Up to approximately 52 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinicohematologic Response (CHR) Rate
Tidsramme: Up to approximately 52 weeks
|
CHR rate is the percentage of participants with CHR, defined as a confirmed reduction of platelet count to ≤400 × 10^9/L and absence of WBC count elevation to >10 × 10^9/L locally assessed to be due to ET, maintained for at least 12 weeks, and the absence of any thrombotic or major hemorrhagic events or disease progression to MF, MDS or AML by Week 52.
|
Up to approximately 52 weeks
|
|
Hematologic Response (HR) Rate
Tidsramme: Up to approximately 52 weeks
|
HR rate is the percentage of participants with HR, HR is defined as the time from the first confirmed hematologic response to first documented evidence of confirmed platelet increase or confirmed WBC increase after latest confirmed hematologic response date.
|
Up to approximately 52 weeks
|
|
Change From Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score
Tidsramme: Baseline and pre-specified timepoints through Week 52
|
The PROMIS Fatigue SF-7a is a 7-item participant-reported assessment that measures both the experience of fatigue and the interference of fatigue on daily activities over the past week.
Response options are on a 5-point Likert scale, ranging from 1 = never to 5 = always.
The total score is used in the analysis and is obtained by summing keyed scores of all items.
Scores can range from 7 to 35, with higher scores indicating greater fatigue.
|
Baseline and pre-specified timepoints through Week 52
|
|
Change From Baseline in Total Symptom Score as Measured on the MFSAF v4.0
Tidsramme: Baseline and pre-specified timepoints through Week 52
|
The MFSAF v4.0 is a 7-item participant-reported myelofibrosis symptom assessment which asks respondents to report symptom severity at its worst for each of the 7 items on a 0 (Absent) to 10 (Worst Imaginable) numeric rating scale.
|
Baseline and pre-specified timepoints through Week 52
|
|
Duration of Durable Clinicohematologic Response (DODCHR)
Tidsramme: Up to approximately 52 weeks
|
For participants who demonstrate DCHR, DODCHR is defined as the time from the first documented evidence of confirmed reduction of platelet and WBC counts until confirmed increase of platelet and WBC counts to above acceptable threshold, thrombotic or major hemorrhagic events, or disease progression to MF, MDS or AML.
|
Up to approximately 52 weeks
|
|
Duration of Clinicohematologic Response (DOCHR)
Tidsramme: Up to approximately 52 weeks
|
For participants who demonstrate CHR, DOCHR is defined as the time from the first documented evidence of confirmed reduction of platelet and WBC counts until confirmed increase of platelet and WBC count to above acceptable threshold, thrombotic or major hemorrhagic events, or disease progression to MF, MDS or AML.
|
Up to approximately 52 weeks
|
|
Duration of Hematologic Response (DOHR)
Tidsramme: Up to approximately 52 weeks
|
For participants who demonstrate HR, DOHR is defined as the time from the first confirmed hematologic response to first documented evidence of confirmed platelet increase or confirmed WBC increase after latest confirmed hematologic response date.
|
Up to approximately 52 weeks
|
|
Percentage of Participants with Thrombotic Events
Tidsramme: Up to approximately 52 weeks
|
Thrombotic events include but are not limited to new or recurrent acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep venous thrombosis, pulmonary embolism, thrombotic digital ischemia, or other thrombotic events.
|
Up to approximately 52 weeks
|
|
Percentage of Participants with Major Hemorrhagic Events
Tidsramme: Up to approximately 52 weeks
|
Major hemorrhagic events include but are not limited to fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a decrease in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells.
|
Up to approximately 52 weeks
|
|
Percentage of Participants with Disease Progression to Post-ET MF or MDS/AML
Tidsramme: Up to approximately 52 weeks
|
Disease progression rate is the percentage of participants with disease progression, defined as the transformation to post-ET MF, MDS, or AML as assessed by the adjudication committee.
|
Up to approximately 52 weeks
|
|
Number of Participants with An Adverse Event (AE)
Tidsramme: Up to approximately 52 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
|
Up to approximately 52 weeks
|
|
Number of Participants Discontinuing From Study Therapy Due to an AE
Tidsramme: Up to approximately 52 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
|
Up to approximately 52 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
31. december 2023
Primær færdiggørelse (Anslået)
30. juli 2027
Studieafslutning (Anslået)
18. august 2028
Datoer for studieregistrering
Først indsendt
6. oktober 2023
Først indsendt, der opfyldte QC-kriterier
6. oktober 2023
Først opslået (Faktiske)
12. oktober 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hæmatologiske sygdomme
- Blodkoagulationsforstyrrelser
- Knoglemarvssygdomme
- Hæmoragiske lidelser
- Blodpladeforstyrrelser
- Myeloproliferative lidelser
- Hemiske og lymfatiske sygdomme
- Trombocytose
- Trombocytæmi, essentiel
- Svovlforbindelser
- Organiske kemikalier
- Kulbrinter, acyklisk
- Kulbrinter
- Alkaner
- Alkoholer
- Butylenglycoler
- Glycols
- Mesylater
- Alkanesulfonater
- Alkanesulfonsyrer
- Sulfonsyrer
- Svovlsyrer
- Busulfan
- Ruxolitinib
- Bomedemstat
- anagrelide
Andre undersøgelses-id-numre
- 3543-006
- IMG-7289-CTP-301 (Anden identifikator: Imagobio)
- MK-3543-006 (Anden identifikator: MSD)
- jRCT2031230658 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
- U1111-1290-2942 (Registry Identifier: UTN)
- 2023-504865-21-00 (Registry Identifier: EU CT)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .