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)

NCT06079879 | Active Not Recruiting Phase 3 DMC FDA Drug

• 6 other identifiers: 3543-0062023-504865-21-00IMG-7289-CTP-301MK-3543-006jRCT2031230658U1111-1290-2942
• Study Type: interventional
• Target: 340
• Locations: 24 countries
• Sites: 163

Brief 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).

Conditions

Essential Thrombocythemia

Keywords

essential thrombocythemia; ET; bomedemstat; IMG-7289

Outcome Measures

Primary Outcomes (1)

• Durable Clinicohematologic Response (DCHR) Rate

  DCHR rate is the percentage of participants with DCHR, defined as a confirmed reduction of platelet count to ≤400 × 10\^9/L, absence of white blood cell (WBC) count elevation to \>10 × 10\^9/L locally assessed to be due to ET, 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

Secondary Outcomes (10)

• Change From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 Individual Fatigue Symptom Item Score

  Baseline and pre-specified timepoints through Week 156

• Change From Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score

  Baseline and pre-specified timepoints through Week 156

• Change From Baseline in Total Symptom Score as Measured on the MFSAF v4.0

  Baseline and pre-specified timepoints through Week 156

• Duration of Clinicohematologic Response (DOCHR)

  Up to approximately 52 weeks

• Duration of Hematologic Remission (DOHR)

  Up to approximately 52 weeks

Study Arms (2)

Bomedemstat

EXPERIMENTAL

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.

Drug: Bomedemstat

Best Available Therapy

ACTIVE COMPARATOR

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.

Drug: Anagrelide; Drug: Busulfan; Drug: Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b; Drug: Ruxolitinib

Interventions

Bomedemstat DRUG

Oral Capsule

Also known as: MK-3543, IMG-7289, Bomedemstat tosylate

Bomedemstat

Anagrelide DRUG

Oral Capsule

Best Available Therapy

Busulfan DRUG

Oral Tablet

Best Available Therapy

Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b DRUG

Subcutaneous Solution

Best Available Therapy

Ruxolitinib DRUG

Oral Tablet

Best Available Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (163)

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

Glendale, Arizona, 85304, United States

Location

Los Angeles Cancer Network ( Site 3491)

Glendale, California, 91206, United States

Location

Stanford Cancer Institute ( Site 0107)

Stanford, California, 94305-5826, United States

Location

The Lundquist Institute ( Site 3423)

Torrance, California, 90502, United States

Location

University of Colorado Anschutz Medical Campus ( Site 3425)

Aurora, Colorado, 80045, United States

Location

Tufts Medical Center ( Site 3408)

Boston, Massachusetts, 02111, United States

Location

University of Michigan ( Site 0008)

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital ( Site 3413)

Detroit, Michigan, 48202, United States

Location

Optum Care Cancer Center ( Site 3497)

Las Vegas, Nevada, 89102, United States

Location

Roswell Park Cancer Institute ( Site 3421)

Buffalo, New York, 14263, United States

Location

Duke University Health System (DUHS) ( Site 0016)

Durham, North Carolina, 27710, United States

Location

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

Winston-Salem, North Carolina, 27157, United States

Location

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

Eugene, Oregon, 97401, United States

Location

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

Charleston, South Carolina, 29425, United States

Location

University of Virginia ( Site 3422)

Charlottesville, Virginia, 22908, United States

Location

VCU Health Adult Outpatient Pavillion ( Site 3416)

Richmond, Virginia, 23219, United States

Location

Hospital Universitario Austral ( Site 0104)

Pilar, Buenos Aires, B1629AHJ, Argentina

Location

Hospital Italiano de Buenos Aires ( Site 0105)

ABB, Buenos Aires F.D., C1199ABB, Argentina

Location

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

San Miguel de Tucumán, Tucumán Province, T4000IKO, Argentina

Location

Royal Prince Alfred Hospital ( Site 1100)

Camperdown, New South Wales, 2050, Australia

Location

Liverpool Hospital-Haematology ( Site 0501)

Liverpool, New South Wales, 2170, Australia

Location

Royal North Shore Hospital ( Site 0003)

St Leonards, New South Wales, 2065, Australia

Location

Calvary Mater Newcastle ( Site 0505)

Waratah, New South Wales, 2298, Australia

Location

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

Adelaide, South Australia, 5000, Australia

Location

Monash Health-Haematology Research ( Site 0006)

Clayton, Victoria, 3168, Australia

Location

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

Melbourne, Victoria, 3021, Australia

Location

Royal Perth Hospital-Haematology ( Site 0504)

Perth, Western Australia, 6000, Australia

Location

ZAS Cadix ( Site 1200)

Antwerp, 2030, Belgium

Location

University Of Alberta Hospital ( Site 1504)

Edmonton, Alberta, T6G 2B7, Canada

Location

The Moncton Hospital-Oncology ( Site 1500)

Moncton, New Brunswick, E1C 6Z8, Canada

Location

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

Bengbu, Anhui, 233004, China

Location

Anhui Provincial Hospital ( Site 3513)

Hefei, Anhui, 230071, China

Location

Peking University Third Hospital-Hematology ( Site 3502)

Beijing, Beijing Municipality, 100191, China

Location

Peking Union Medical College Hospital ( Site 3531)

Beijing, Beijing Municipality, 100730, China

Location

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

Quanzhou, Fujian, 362000, China

Location

The First Affiliated hospital of Xiamen University ( Site 3515)

Xiamen, Fujian, 361003, China

Location

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

Guangzhou, Guangdong, 510120, China

Location

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

Guangzhou, Guangdong, 510515, China

Location

The First Hospital of Hebei Medical University ( Site 3510)

Shijiazhuang, Hebei, 050031, China

Location

Henan Cancer Hospital-hematology department ( Site 3504)

Zhengzhou, Henan, 450008, China

Location

Wuhan Union Hospital ( Site 3500)

Wuhan, Hubei, 430022, China

Location

Jiangsu Province Hospital ( Site 3507)

Nanjing, Jiangsu, 210029, China

Location

Affiliated Hospital of Nantong University ( Site 3527)

Nantong, Jiangsu, 226001, China

Location

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

Nanchang, Jiangxi, 330209, China

Location

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

Changchun, Jilin, 130021, China

Location

Shaanxi provincial people's hospital ( Site 3516)

Xi'an, Shaanxi, 710068, China

Location

Jinan Central Hospital ( Site 3523)

Jinan, Shandong, 250013, China

Location

Zhongshan Hospital,Fudan University-Hematology ( Site 3530)

Shanghai, Shanghai Municipality, 200032, China

Location

Huashan Hospital, Fudan University ( Site 3529)

Shanghai, Shanghai Municipality, 200040, China

Location

West China Hospital, Sichuan University ( Site 3518)

Chengdu, Sichuan, 610041, China

Location

Institute of hematology&blood disease hospital ( Site 3501)

Tianjin, Tianjin Municipality, 300020, China

Location

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

Hangzhou, Zhejiang, 310006, China

Location

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

Yiwu, Zhejiang, 322000, China

Location

Fundacion Colombiana de Cancerología Clinica Vida ( Site 1403)

Medellín, Antioquia, 050030, Colombia

Location

Los Cobos Medical Center ( Site 1404)

Bogotá, Bogota D.C., 110121, Colombia

Location

IMAT S.A.S ( Site 1401)

Montería, Departamento de Córdoba, 230002, Colombia

Location

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

Rennes, Brittany Region, 35000, France

Location

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

Tours, Indre-et-Loire, 37000, France

Location

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

Limoges, Limousin, 87042, France

Location

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

Vandœuvre-lès-Nancy, Lorraine, 54511, France

Location

Centre Hospitalier de Roubaix ( Site 1703)

Roubaix, Nord, 59100, France

Location

centre hospitalier lyon sud ( Site 0406)

Pierre-Bénite, Rhone, 69310, France

Location

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

Paris, 75010, France

Location

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

Paris, Île-de-France Region, 75571, France

Location

Universitätsklinikum Aachen ( Site 1801)

Aachen, North Rhine-Westphalia, 52074, Germany

Location

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

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Halle ( Site 0401)

Halle, Saxony-Anhalt, 06120, Germany

Location

Queen Mary Hospital ( Site 1901)

Hksar, Hong Kong

Location

Petz Aladar Egyetemi Oktato Korhaz ( Site 2000)

Győr, Győr-Moson-Sopron, Hungary

Location

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

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 0708)

Budapest, 1088, Hungary

Location

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

Debrecen, 4032, Hungary

Location

Soroka Medical Center ( Site 2100)

Beersheba, 8410101, Israel

Location

Rambam Health Care Campus ( Site 2102)

Haifa, 3109601, Israel

Location

Carmel Hospital ( Site 0906)

Haifa, 3436212, Israel

Location

Hadassah Medical Center ( Site 0904)

Jerusalem, 9112001, Israel

Location

Rabin Medical Center ( Site 0905)

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center ( Site 2101)

Ramat Gan, 5265601, Israel

Location

Sourasky Medical Center ( Site 0902)

Tel Aviv, 6423906, Israel

Location

Yitzhak Shamir Medical Center. ( Site 0901)

Ẕerifin, 7033001, Israel

Location

Azienda Ospedaliero Universitaria di Ferrara ( Site 0304)

Cona, Ferrara, 44124, Italy

Location

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

Meldola, Forli-Cesena, 47014, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2201)

Milan, Lombardy, 20122, Italy

Location

Azienda Ospedaliera Universitaria Careggi ( Site 0030)

Florence, Tuscany, 50134, Italy

Location

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

Pisa, Tuscany, 56126, Italy

Location

Istituto Oncologico Veneto IRCCS-Oncoematologia ( Site 0306)

Castelfranco Veneto, Veneto, 31033, Italy

Location

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

Alessandria, 15121, Italy

Location

Azienda Ospedaliero Universitaria delle Marche ( Site 0302)

Ancona, 60126, Italy

Location

Arcispedale Santa Maria Nuova ( Site 0301)

Reggio Emilia, 42123, Italy

Location

Ospedale Mauriziano ( Site 0305)

Torino, 10128, Italy

Location

Ospedale di Circolo e Fondazione Macchi Varese ( Site 2200)

Varese, 21100, Italy

Location

Fujita Health University Hospital ( Site 3613)

Toyoake, Aichi-ken, 470-1192, Japan

Location

National Cancer Center Hospital East ( Site 3610)

Kashiwa, Chiba, 277-8577, Japan

Location

Ehime University Hospital ( Site 3612)

Tōon, Ehime, 791-0295, Japan

Location

Hokkaido University Hospital ( Site 3601)

Sapporo, Hokkaido, 060-8648, Japan

Location

Kobe City Medical Center General Hospital ( Site 3603)

Kobe, Hyōgo, 650-0047, Japan

Location

Kanazawa University Hospital ( Site 3614)

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Mie University Hospital ( Site 3615)

Tsu, Mie-ken, 514-8507, Japan

Location

National Hospital Organization Sendai Medical Center ( Site 3617)

Sendai, Miyagi, 983-8520, Japan

Location

Kansai Medical University Hospital ( Site 3607)

Hirakata, Osaka, 573-1191, Japan

Location

Kindai University Hospital ( Site 3600)

Sakai, Osaka, 590-0197, Japan

Location

Juntendo University Hospital ( Site 3611)

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Nippon Medical School Hospital ( Site 3608)

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

University of Yamanashi Hospital ( Site 3606)

Chūō, Yamanashi, 409-3898, Japan

Location

Kyushu University Hospital ( Site 3605)

Fukuoka, 812-8582, Japan

Location

Fukushima Medical University Hospital ( Site 3616)

Fukushima, 960-1295, Japan

Location

University of Miyazaki Hospital ( Site 3609)

Miyazaki, 889-1692, Japan

Location

Okayama University Hospital ( Site 3604)

Okayama, 700-8558, Japan

Location

Spaarne Gasthuis - Hoofddorp-Oncology ( Site 2301)

Hoofddorp, North Holland, 2134 TM, Netherlands

Location

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

Dordrecht, South Holland, 3318 AT, Netherlands

Location

University Medical Center Groningen ( Site 2304)

Groningen, 9713 GZ, Netherlands

Location

Martini Ziekenhuis ( Site 2300)

Groningen, 9728 NT, Netherlands

Location

North Shore Hospital-Department of Haematology ( Site 0051)

Auckland, 0622, New Zealand

Location

Aotearoa Clinical Trials ( Site 0050)

Auckland, 2025, New Zealand

Location

Pratia Onkologia Katowice ( Site 0702)

Katowice, Silesian Voivodeship, 40-519, Poland

Location

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

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

Location

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

Braga, 4710-243, Portugal

Location

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

Lisbon, 1449-005, Portugal

Location

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

Porto, 4200-072, Portugal

Location

Seoul National University Bundang Hospital-Hematology ( Site 0605)

Seongnam, Kyonggi-do, 13620, South Korea

Location

Korea University Anam Hospital ( Site 0604)

Seoul, 02841, South Korea

Location

Asan Medical Center ( Site 0603)

Seoul, 05505, South Korea

Location

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

Seoul, 06591, South Korea

Location

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

Badalona, Barcelona, 08916, Spain

Location

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

L'Hospitalet Del Llobregat, Barcelona, 08908, Spain

Location

Hospital del Mar ( Site 2807)

Barcelona, Catalonia, 08003, Spain

Location

HOSPITAL CLÍNIC DE BARCELONA ( Site 2800)

Barcelona, Catalonia, 08036, Spain

Location

CHUS - Hospital Clinico Universitario ( Site 0421)

Santiago de Compostela, La Coruna, 19706, Spain

Location

Hospital Universitario Ramón y Cajal-Hematology ( Site 2803)

Madrid, Madrid, Comunidad de, 28034, Spain

Location

Hospital Costa del Sol-Hematology Service ( Site 0412)

Marbella, Malaga, 29603, Spain

Location

Hospital General Universitario de Albacete ( Site 0408)

Albacete, 02006, Spain

Location

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

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre ( Site 2806)

Madrid, 28041, Spain

Location

Hospital Universitario Virgen de la Victoria ( Site 0418)

Málaga, 29010, Spain

Location

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

Salamanca, 37007, Spain

Location

Hospital Universitario Doctor Peset ( Site 0411)

Valencia, 46017, Spain

Location

Karolinska Universitetssjukhuset Huddinge ( Site 2900)

Huddinge, Stockholm County, 141 86, Sweden

Location

Universitetssjukhuset Örebro ( Site 0403)

Örebro, Örebro County, 701 85, Sweden

Location

Chang Gung Memorial Hospital- Chiayi ( Site 3102)

Chiayi City, Chiayi, 613, Taiwan

Location

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

Kaohsiung City, 83301, Taiwan

Location

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

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 3101)

Taipei, 10048, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch ( Site 3103)

Taoyuan, 33305, Taiwan

Location

Ege Universitesi Hastanesi ( Site 3202)

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri-Department of Hematology ( Site 3204)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 3210)

Ankara, 06620, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi ( Site 3201)

Ankara, 06800, Turkey (Türkiye)

Location

Antalya Egitim ve Arastırma Hastanesi ( Site 3207)

Antalya, 07100, Turkey (Türkiye)

Location

Trakya University Medical Faculty Hospital-Hematology ( Site 3200)

Edirne, 22030, Turkey (Türkiye)

Location

Medipol Mega Universite Hastanesi-oncology ( Site 3203)

Istanbul, 34214, Turkey (Türkiye)

Location

Kocaeli Üniversitesi-Hematology ( Site 3205)

Kocaeli, 41380, Turkey (Türkiye)

Location

VM Medical Park Mersin Hastanesi ( Site 3208)

Mersin, 33440, Turkey (Türkiye)

Location

Ondokuz Mayıs Universitesi-hematology ( Site 3206)

Samsun, 55270, Turkey (Türkiye)

Location

Addenbrooke's Hospital ( Site 3303)

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

Gloucestershire Royal Hospital ( Site 3302)

Gloucester, Gloucestershire, Gl1 3NN, United Kingdom

Location

Lincoln County Hospital ( Site 3310)

Lincoln, Great Britain, LN2 5QY, United Kingdom

Location

Boston Pilgrim Hospital ( Site 3301)

Boston, Lincolnshire, PE21 9QS, United Kingdom

Location

University College London Hospital ( Site 3300)

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

Location

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

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

Location

King's College Hospital ( Site 3308)

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

Location

Royal Gwent Hospital ( Site 3304)

Gwent, Newport, NP20 2UB, United Kingdom

Location

GenesisCare - Windsor ( Site 3309)

Windsor, Windsor And Maidenhead, SL4 3HD, United Kingdom

Location

The Christie NHS Foundation Trust ( Site 3307)

Manchester, m20 4bx, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Thrombocythemia, Essential

Interventions

bomedemstat; anagrelide; Busulfan; ruxolitinib

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombocytosis; Blood Platelet Disorders; Myeloproliferative Disorders; Bone Marrow Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: December 31, 2023
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 18, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

TW (5); DE (3); AR (3); NL (4); KR (4); BE (1); TU (10); US (16); FR (8); JP (17); HK (1); CO (3); IT (11); AU (8); SE (2); PT (3); HU (4); ES (13); CA (2); CN (23); NZ (2); GB (10); PL (2); IL (8)