AzTrials
AzTrials

Essential ThrombocythemiaPhase 3NCT06079879

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)

A Phase 3 study testing Bomedemstat, Anagrelide and Busulfan in people with Essential Thrombocythemia, run by Merck Sharp & Dohme LLC at 161 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Essential Thrombocythemia
What is being tested?
Bomedemstat, Anagrelide and Busulfan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
161 sitesin 24 countries
Study dates
31 Dec 2023to 18 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

161 sites in 24 countries.

161 sites in 24 countries

China23 sites

  • Peking University Third Hospital-Hematology ( Site 3502)

    Beijing, Beijing Municipality, 100191

  • Peking Union Medical College Hospital ( Site 3531)

    Beijing, Beijing Municipality, 100730

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

    Bengbu, Anhui, 233004

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

    Changchun, Jilin, 130021

  • West China Hospital, Sichuan University ( Site 3518)

    Chengdu, Sichuan, 610041

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

    Guangzhou, Guangdong, 510120

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

    Guangzhou, Guangdong, 510515

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

    Hangzhou, Zhejiang, 310003

  • Anhui Provincial Hospital ( Site 3513)

    Hefei, Anhui, 230071

  • Jinan Central Hospital ( Site 3523)

    Jinan, Shandong, 250013

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

    Nanchang, Jiangxi, 330209

  • Jiangsu Province Hospital ( Site 3507)

    Nanjing, Jiangsu, 210029

  • Affiliated Hospital of Nantong University ( Site 3527)

    Nantong, Jiangsu, 226001

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

    Quanzhou, Fujian, 362000

  • Zhongshan Hospital,Fudan University-Hematology ( Site 3530)

    Shanghai, Shanghai Municipality, 200032

  • Huashan Hospital, Fudan University ( Site 3529)

    Shanghai, Shanghai Municipality, 200040

  • The First Hospital of Hebei Medical University ( Site 3510)

    Shijiazhuang, Hebei, 050031

  • Institute of hematology&blood disease hospital ( Site 3501)

    Tianjin, Tianjin Municipality, 300020

  • Wuhan Union Hospital ( Site 3500)

    Wuhan, Hubei, 430022

  • Shaanxi provincial people's hospital ( Site 3516)

    Xi'an, Shaanxi, 710068

  • The First Affiliated hospital of Xiamen University ( Site 3515)

    Xiamen, Fujian, 361003

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

    Yiwu, Zhejiang, 322000

  • Henan Cancer Hospital-hematology department ( Site 3504)

    Zhengzhou, Henan, 450008

Other trials in China

Japan17 sites

  • Juntendo University Hospital ( Site 3611)

    Bunkyo-ku, Tokyo, 113-8431

  • Nippon Medical School Hospital ( Site 3608)

    Bunkyo-ku, Tokyo, 113-8603

  • University of Yamanashi Hospital ( Site 3606)

    Chūō, Yamanashi, 409-3898

  • Kyushu University Hospital ( Site 3605)

    Fukuoka, 812-8582

  • Fukushima Medical University Hospital ( Site 3616)

    Fukushima, 960-1295

  • Kansai Medical University Hospital ( Site 3607)

    Hirakata, Osaka, 573-1191

  • Kanazawa University Hospital ( Site 3614)

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East ( Site 3610)

    Kashiwa, Chiba, 277-8577

  • Kobe City Medical Center General Hospital ( Site 3603)

    Kobe, Hyōgo, 650-0047

  • University of Miyazaki Hospital ( Site 3609)

    Miyazaki, 889-1692

  • Okayama University Hospital ( Site 3604)

    Okayama, 700-8558

  • Kindai University Hospital ( Site 3600)

    Sakai, Osaka, 590-0197

  • Hokkaido University Hospital ( Site 3601)

    Sapporo, Hokkaido, 060-8648

  • National Hospital Organization Sendai Medical Center ( Site 3617)

    Sendai, Miyagi, 983-8520

  • Ehime University Hospital ( Site 3612)

    Tōon, Ehime, 791-0295

  • Fujita Health University Hospital ( Site 3613)

    Toyoake, Aichi-ken, 470-1192

  • Mie University Hospital ( Site 3615)

    Tsu, Mie-ken, 514-8507

Other trials in Japan

United States15 sites

  • University of Michigan ( Site 0008)

    Ann Arbor, Michigan, 48109

  • University of Colorado Anschutz Medical Campus ( Site 3425)

    Aurora, Colorado, 80045

  • Tufts Medical Center ( Site 3408)

    Boston, Massachusetts, 02111

  • Roswell Park Cancer Institute ( Site 3421)

    Buffalo, New York, 14263

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

    Charleston, South Carolina, 29425

  • University of Virginia ( Site 3422)

    Charlottesville, Virginia, 22908

  • Henry Ford Hospital ( Site 3413)

    Detroit, Michigan, 48202

  • Duke University Health System (DUHS) ( Site 0016)

    Durham, North Carolina, 27710

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

    Glendale, Arizona, 85304

  • Los Angeles Cancer Network ( Site 3491)

    Glendale, California, 91206

  • Optum Care Cancer Center ( Site 3497)

    Las Vegas, Nevada, 89102

  • VCU Health Adult Outpatient Pavillion ( Site 3416)

    Richmond, Virginia, 23219

  • Stanford Cancer Institute ( Site 0107)

    Stanford, California, 94305-5826

  • The Lundquist Institute ( Site 3423)

    Torrance, California, 90502

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

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain13 sites

  • Hospital General Universitario de Albacete ( Site 0408)

    Albacete, 02006

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

    Badalona, Barcelona, 08916

  • Hospital del Mar ( Site 2807)

    Barcelona, Catalonia, 08003

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 2800)

    Barcelona, Catalonia, 08036

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

    Barcelona, 08035

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

    L'Hospitalet Del Llobregat, Barcelona, 08908

  • Hospital Universitario Ramón y Cajal-Hematology ( Site 2803)

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario 12 de Octubre ( Site 2806)

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria ( Site 0418)

    Málaga, 29010

  • Hospital Costa del Sol-Hematology Service ( Site 0412)

    Marbella, Malaga, 29603

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

    Salamanca, 37007

  • CHUS - Hospital Clinico Universitario ( Site 0421)

    Santiago de Compostela, La Coruna, 15706

  • Hospital Universitario Doctor Peset ( Site 0411)

    Valencia, 46017

Other trials in Spain

Italy11 sites

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

    Alessandria, 15121

  • Azienda Ospedaliero Universitaria delle Marche ( Site 0302)

    Ancona, 60126

  • Istituto Oncologico Veneto IRCCS-Oncoematologia ( Site 0306)

    Castelfranco Veneto, Veneto, 31033

  • Azienda Ospedaliero Universitaria di Ferrara ( Site 0304)

    Cona, Ferrara, 44124

  • Azienda Ospedaliera Universitaria Careggi ( Site 0030)

    Florence, Tuscany, 50134

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

    Meldola, Forli-Cesena, 47014

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2201)

    Milan, Lombardy, 20122

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

    Pisa, Tuscany, 56126

  • Arcispedale Santa Maria Nuova ( Site 0301)

    Reggio Emilia, 42123

  • Ospedale Mauriziano ( Site 0305)

    Torino, 10128

  • Ospedale di Circolo e Fondazione Macchi Varese ( Site 2200)

    Varese, 21100

Other trials in Italy

Turkey (Türkiye)10 sites

  • Hacettepe Universite Hastaneleri-Department of Hematology ( Site 3204)

    Ankara, 06230

  • Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 3210)

    Ankara, 06620

  • Ankara Bilkent Şehir Hastanesi ( Site 3201)

    Ankara, 06800

  • Antalya Egitim ve Arastırma Hastanesi ( Site 3207)

    Antalya, 07100

  • Ege Universitesi Hastanesi ( Site 3202)

    Bornova, İzmir, 35100

  • Trakya University Medical Faculty Hospital-Hematology ( Site 3200)

    Edirne, 22030

  • Medipol Mega Universite Hastanesi-oncology ( Site 3203)

    Istanbul, 34214

  • Kocaeli Üniversitesi-Hematology ( Site 3205)

    Kocaeli, 41380

  • VM Medical Park Mersin Hastanesi ( Site 3208)

    Mersin, 33440

  • Ondokuz Mayıs Universitesi-hematology ( Site 3206)

    Samsun, 55270

Other trials in Turkey (Türkiye)

United Kingdom10 sites

  • Boston Pilgrim Hospital ( Site 3301)

    Boston, Lincolnshire, PE21 9QS

  • Addenbrooke's Hospital ( Site 3303)

    Cambridge, Cambridgeshire, CB2 2QQ

  • Gloucestershire Royal Hospital ( Site 3302)

    Gloucester, Gloucestershire, Gl1 3NN

  • Royal Gwent Hospital ( Site 3304)

    Gwent, Newport, NP20 2UB

  • Lincoln County Hospital ( Site 3310)

    Lincoln, Great Britain, LN2 5QY

  • University College London Hospital ( Site 3300)

    London, London, City of, NW1 2PG

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

    London, London, City of, SE1 9RT

  • King's College Hospital ( Site 3308)

    London, London, City of, SE5 9RS

  • The Christie NHS Foundation Trust ( Site 3307)

    Manchester, m20 4bx

  • GenesisCare - Windsor ( Site 3309)

    Windsor, Windsor And Maidenhead, SL4 3HD

Other trials in United Kingdom

Australia8 sites

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

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital ( Site 1100)

    Camperdown, New South Wales, 2050

  • Monash Health-Haematology Research ( Site 0006)

    Clayton, Victoria, 3168

  • Liverpool Hospital-Haematology ( Site 0501)

    Liverpool, New South Wales, 2170

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

    Melbourne, Victoria, 3021

  • Royal Perth Hospital-Haematology ( Site 0504)

    Perth, Western Australia, 6000

  • Royal North Shore Hospital ( Site 0003)

    St Leonards, New South Wales, 2065

  • Calvary Mater Newcastle ( Site 0505)

    Waratah, New South Wales, 2298

Other trials in Australia

France8 sites

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

    Limoges, Limousin, 87042

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

    Paris, 75010

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

    Paris, Île-de-France Region, 75571

  • centre hospitalier lyon sud ( Site 0406)

    Pierre-Bénite, Rhone, 69310

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

    Rennes, Brittany Region, 35000

  • Centre Hospitalier de Roubaix ( Site 1703)

    Roubaix, Nord, 59100

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

    Tours, Indre-et-Loire, 37000

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

    Vandœuvre-lès-Nancy, Lorraine, 54511

Other trials in France

Israel8 sites

  • Soroka Medical Center ( Site 2100)

    Beersheba, 8410101

  • Rambam Health Care Campus ( Site 2102)

    Haifa, 3109601

  • Carmel Hospital ( Site 0906)

    Haifa, 3436212

  • Hadassah Medical Center ( Site 0904)

    Jerusalem, 9112001

  • Rabin Medical Center ( Site 0905)

    Petah Tikva, 4941492

  • Sheba Medical Center ( Site 2101)

    Ramat Gan, 5265601

  • Sourasky Medical Center ( Site 0902)

    Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center. ( Site 0901)

    Tsrifin, 7033001

Other trials in Israel

Taiwan5 sites

  • Chang Gung Memorial Hospital- Chiayi ( Site 3102)

    Chiayi City, Chiayi, 613

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

    Kaohsiung City, 83301

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

    Tainan, 704

  • National Taiwan University Hospital ( Site 3101)

    Taipei, 10048

  • Chang Gung Medical Foundation-Linkou Branch ( Site 3103)

    Taoyuan, 33305

Other trials in Taiwan

Hungary4 sites

  • Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 0708)

    Budapest, 1088

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

    Debrecen, 4032

  • Petz Aladar Egyetemi Oktato Korhaz ( Site 2000)

    Győr, Győr-Moson-Sopron

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

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

Other trials in Hungary

Netherlands4 sites

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

    Dordrecht, South Holland, 3318 AT

  • University Medical Center Groningen ( Site 2304)

    Groningen, 9700 RB

  • Martini Ziekenhuis ( Site 2300)

    Groningen, 9728 NT

  • Spaarne Gasthuis - Hoofddorp-Oncology ( Site 2301)

    Hoofddorp, North Holland, 2134 TM

Other trials in Netherlands

South Korea4 sites

  • Seoul National University Bundang Hospital-Hematology ( Site 0605)

    Seongnam, Kyonggi-do, 13620

  • Korea University Anam Hospital ( Site 0604)

    Seoul, 02841

  • Asan Medical Center ( Site 0603)

    Seoul, 05505

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

    Seoul, 06591

Other trials in South Korea

Argentina3 sites

  • Hospital Italiano de Buenos Aires ( Site 0105)

    ABB, Buenos Aires F.D., C1199ABB

  • Hospital Universitario Austral ( Site 0104)

    Pilar, Buenos Aires, B1629AHJ

  • C.I.C.E. 9 de Julio ( Site 1001)

    San Miguel de Tucumán, Tucumán Province, T4000IKO

Other trials in Argentina

Colombia3 sites

  • Los Cobos Medical Center ( Site 1404)

    Bogotá, Bogota D.C., 110121

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1403)

    Medellín, Antioquia, 050030

  • IMAT S.A.S ( Site 1401)

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

Germany3 sites

  • Universitätsklinikum Aachen ( Site 1801)

    Aachen, North Rhine-Westphalia, 52074

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

    Dresden, Saxony, 01307

  • Universitätsklinikum Halle ( Site 0401)

    Halle, Saxony-Anhalt, 06120

Other trials in Germany

Portugal3 sites

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

    Braga, 4710-243

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

    Lisbon, 1449-005

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

    Porto, 4200-072

Other trials in Portugal

New Zealand2 sites

  • North Shore Hospital-Department of Haematology ( Site 0051)

    Auckland, 0622

  • Aotearoa Clinical Trials ( Site 0050)

    Auckland, 2025

Other trials in New Zealand

Poland2 sites

  • Pratia Onkologia Katowice ( Site 0702)

    Katowice, Silesian Voivodeship, 40-519

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

    Kielce, Świętokrzyskie Voivodeship, 25-734

Other trials in Poland

Sweden2 sites

  • Karolinska Universitetssjukhuset Huddinge ( Site 2900)

    Huddinge, Stockholm County, 141 86

  • Universitetssjukhuset Örebro ( Site 0403)

    Örebro, Örebro County, 701 85

Other trials in Sweden

Belgium1 site

  • ZAS Cadix ( Site 1200)

    Antwerp, 2030

Other trials in Belgium

Canada1 site

  • The Moncton Hospital-Oncology ( Site 1500)

    Moncton, New Brunswick, E1C 6Z8

Other trials in Canada

Hong Kong1 site

  • Queen Mary Hospital ( Site 1901)

    Hksar

Other trials in Hong Kong

About this study

Official title: A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543/IMG-7289) Versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia Who Have an Inadequate Response to or Are Intolerant of Hydroxyurea

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).

Being tested
Bomedemstat, Anagrelide, Busulfan, Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b, Ruxolitinib
Keywords
essential thrombocythemia, ET, bomedemstat, IMG-7289
Medical subject headings
Thrombocythemia, Essential

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BomedemstatDrug

    Also called MK-3543, IMG-7289, Bomedemstat tosylate

    Oral Capsule

  • AnagrelideDrug

    Oral Capsule

  • BusulfanDrug

    Oral Tablet

  • Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2bDrug

    Subcutaneous Solution

  • RuxolitinibDrug

    Oral Tablet

Study groups in NCT06079879
Study groupRoleWhat they receive
BomedemstatExperimentalParticipants 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.
Receives: Drug: Bomedemstat
Best Available TherapyActive comparatorEach 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.
Receives: Drug: Anagrelide; Drug: Busulfan; Drug: Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b; Drug: Ruxolitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 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.

    Measured: Up to approximately 52 weeks

Secondary outcomes (12)

  1. Clinicohematologic Response (CHR) Rate

    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.

    Measured: Up to approximately 52 weeks

  2. Hematologic Response (HR) Rate

    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.

    Measured: Up to approximately 52 weeks

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

    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.

    Measured: Baseline and pre-specified timepoints through Week 52

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

    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.

    Measured: Baseline and pre-specified timepoints through Week 52

  5. Duration of Durable Clinicohematologic Response (DODCHR)

    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.

    Measured: Up to approximately 52 weeks

  6. Duration of Clinicohematologic Response (DOCHR)

    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.

    Measured: Up to approximately 52 weeks

  7. Duration of Hematologic Response (DOHR)

    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.

    Measured: Up to approximately 52 weeks

  8. Percentage of Participants with Thrombotic Events

    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.

    Measured: Up to approximately 52 weeks

  9. Percentage of Participants with Major Hemorrhagic Events

    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.

    Measured: Up to approximately 52 weeks

  10. Percentage of Participants with Disease Progression to Post-ET MF or MDS/AML

    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.

    Measured: Up to approximately 52 weeks

  11. Number of Participants with An Adverse Event (AE)

    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.

    Measured: Up to approximately 52 weeks

  12. Number of Participants Discontinuing From Study Therapy Due to an AE

    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.

    Measured: Up to approximately 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start31 Dec 2023
  3. Primary completion14 Jul 2027 (estimated)
  4. Study completion18 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06079879
Sponsor's protocol ID
3543-006
Other IDs
2023-504865-21-00, IMG-7289-CTP-301, MK-3543-006, jRCT2031230658, U1111-1290-2942, 2023
Status last verified
Sep 2026
First submitted
6 Oct 2023
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bomedemstat, Anagrelide and Busulfan in people with Essential Thrombocythemia, run by Merck Sharp & Dohme LLC at 161 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in China, Japan, United States, Spain, Italy and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Durable Clinicohematologic Response (DCHR) Rate (time frame: Up to approximately 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06079879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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