Clinical trial NCT06456346: Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Official title: A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) Versus Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Essential Thrombocythemia
Keywords: essential thrombocythemia
ET
bomedemstat
IMG-7289
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-06-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status
* 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 received no prior cytoreductive treatment for their ET
* Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
* Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

* History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
* History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has an active infection requiring systemic therapy
* Has had a major surgery \<4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery \>4 weeks prior to first dose

Primary outcomes:
measure: Durable Clinicohematologic Response (DCHR) Rate
timeFrame: Up to Week 52
Secondary outcomes:
measure: Change From Baseline in Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) Individual Fatigue Symptom Item Score
timeFrame: Baseline and pre-specified timepoints up to Week 52
measure: Change From Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score
timeFrame: Baseline and pre-specified timepoints up to Week 52
measure: Change From Baseline in MFSAF v4.0 Total Symptom Score
timeFrame: Baseline and Week 52
measure: Duration of Hematologic Remission (DOHR)
timeFrame: Up to Week 52
measure: Number of Participants Who Experience Thrombotic Events
timeFrame: Up to approximately 52 weeks
measure: Number of Participants Who Experience Major Hemorrhagic Events
timeFrame: Up to approximately 52 weeks
measure: Disease Progression Rate
timeFrame: Up to Week 52
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 52 weeks
measure: Number of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 52 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Los Angeles Cancer Network ( Site 0025)
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Center ( Site 0024)
state: California
city: Golden
country: United States
facility: Exempla Lutheran Medical Center ( Site 0014)
state: Colorado
city: Fort Wayne
country: United States
facility: Parkview Research Center at Parkview Regional Medical Center ( Site 0006)
state: Indiana
city: Durham
country: United States
facility: Duke University Health System (DUHS) ( Site 0012)
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University ( Site 0018)
state: Oregon
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio ( Site 0021)
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia ( Site 0020)
state: Virginia
city: Richmond
country: United States
facility: VCU Health Adult Outpatient Pavillion ( Site 0008)
state: Virginia
city: Pilar
country: Argentina
facility: Hospital Universitario Austral ( Site 0101)
state: Buenos Aires
city: ABB
country: Argentina
facility: Hospital Italiano de Buenos Aires ( Site 0102)
state: Caba
city: San Miguel de Tucumán
country: Argentina
facility: C.I.C.E. 9 de Julio ( Site 0104)
state: Tucuman
city: Santa Fe
country: Argentina
facility: Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105)
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 0201)
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203)
state: South Australia
city: Clayton
country: Australia
facility: Monash Health-Haematology Research ( Site 0202)
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health-Cancer Clinical Trials Centre ( Site 0206)
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital-Haematology ( Site 0204)
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0562)
state: Oberosterreich
city: Concepcion
country: Chile
facility: Biocenter ( Site 0149)
state: Biobio
city: La Serena.
country: Chile
facility: IC La Serena Research ( Site 0150)
state: Coquimbo
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0148)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica Inmunocel ( Site 0147)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica Alemana de Santiago ( Site 0143)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0142)
state: Region M. De Santiago
city: Medellín
country: Colombia
facility: Fundacion Colombiana de Cancerología Clinica Vida ( Site 0164)
state: Antioquia
city: Monteria
country: Colombia
facility: IMAT S.A.S ( Site 0162)
state: Cordoba
city: Bogota
country: Colombia
facility: Los Cobos Medical Center ( Site 0165)
state: Distrito Capital De Bogota
city: Copenhagen
country: Denmark
facility: Rigshospitalet-Hematology - CTU ( Site 0321)
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324)
state: Midtjylland
city: Roskilde
country: Denmark
facility: Roskilde Sygehus-Department of Hematology ( Site 0323)
state: Sjaelland
city: Odense C
country: Denmark
facility: Odense Universitetshospital-Department of Hematology ( Site 0325)
state: Syddanmark
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology ( Site 0349)
state: Alpes-Maritimes
city: Pessac
country: France
facility: CHU Bordeaux Haut-Leveque-service de mèdecine interne et maladies infectieuses ( Site 0346)
state: Aquitaine
city: Marseille
country: France
facility: Hôpital de la Conception ( Site 0351)
state: Bouches-du-Rhone
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0352)
state: Haute-Garonne
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0344)
state: Haute-Vienne
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0342)
state: Indre-et-Loire
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0347)
state: Loire-Atlantique
city: Pierre-Bénite
country: France
facility: centre hospitalier lyon sud ( Site 0343)
state: Rhone
city: Creteil
country: France
facility: HENRI MONDOR HOSPITAL ( Site 0348)
state: Val-de-Marne
city: Paris
country: France
facility: Hopital Saint-Louis ( Site 0341)
city: Landshut
country: Germany
facility: VK&K Studien GbR ( Site 0370)
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 0371)
state: Niedersachsen
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen ( Site 0367)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 0366)
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Site 0365)
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Universitätsklinikum Halle ( Site 0361)
state: Sachsen-Anhalt
city: Jena
country: Germany
facility: Universitätsklinikum Jena-Klinik für Innere Medizin II, Abt. Hämatologie und Internistische Onkolog ( Site 0364)
state: Thuringen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0369)
city: Hksar
country: Hong Kong
facility: Queen Mary Hospital ( Site 0221)
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 0407)
state: Csongrad
city: Gyor
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz-Hematológia ( Site 0405)
state: Gyor-Moson-Sopron
city: Kaposvár
country: Hungary
facility: Somogy Vármegyei Kaposi Mór Oktató Kórház-Haematológiai osztály ( Site 0406)
state: Somogy
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0404)
state: Szabolcs-Szatmar-Bereg
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center ( Site 0427)
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0429)
city: Haifa
country: Israel
facility: Carmel Hospital ( Site 0426)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 0424)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0425)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0428)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0422)
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center. ( Site 0421)
city: Alessandria
country: Italy
facility: Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0443)
state: Ancona
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0447)
state: Lombardia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi ( Site 0441)
state: Toscana
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0446)
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0444)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0445)
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi Varese ( Site 0442)
city: Toyoake
country: Japan
facility: Fujita Health University Hospital ( Site 0613)
state: Aichi
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 0612)
state: Ehime
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 0601)
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 0603)
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 0614)
state: Ishikawa
city: Tsu
country: Japan
facility: Mie University Hospital ( Site 0615)
state: Mie
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center ( Site 0617)
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 0607)
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 0600)
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital ( Site 0611)
state: Tokyo
city: Chuo
country: Japan
facility: University of Yamanashi Hospital ( Site 0606)
state: Yamanashi
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0605)
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital ( Site 0616)
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital ( Site 0609)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 0604)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 0608)
city: Chihuahua City
country: Mexico
facility: Medivest Centro de Investigación Integral ( Site 0183)
state: Chihuahua
city: Mexico City
country: Mexico
facility: Higiea Oncologia ( Site 0184)
state: Distrito Federal
city: Oaxaca de Juarez.
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 0181)
state: Oaxaca
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp ( Site 0463)
state: Lubelskie
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice ( Site 0461)
state: Slaskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 0466)
state: Swietokrzyskie
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0490)
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla-Haematology ( Site 0486)
state: Cantabria
city: Barcelona
country: Spain
facility: HOSPITAL CLÍNIC DE BARCELONA ( Site 0481)
state: Cataluna
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet ( Site 0482)
state: Cataluna
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra-Hematology Department ( Site 0485)
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal-Hematology ( Site 0484)
state: Madrid, Comunidad De
city: Marbella
country: Spain
facility: Hospital Costa del Sol-Hematology Service ( Site 0493)
state: Malaga
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0489)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre ( Site 0494)
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 0488)
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro ( Site 0542)
state: Orebro Lan
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus Lund-Department of Hematology ( Site 0544)
state: Skane Lan
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge ( Site 0541)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset ( Site 0545)
state: Uppsala Lan
city: Gothenburg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset-Department of hematology and coagulation ( Site 0543)
state: Vastra Gotalands Lan
city: Chiayi City
country: Taiwan
facility: Chang Gung Memorial Hospital- Chiayi ( Site 0242)
state: Chiayi
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 0245)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0241)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 0243)
city: Bodelwyddan
country: United Kingdom
facility: Glan Clwyd Hospital ( Site 0528)
state: Denbighshire
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital ( Site 0521)
state: Gloucestershire
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital ( Site 0535)
state: Great Britain
city: Boston
country: United Kingdom
facility: Boston Pilgrim Hospital ( Site 0525)
state: Lincolnshire
city: London
country: United Kingdom
facility: Hammersmith Hospital ( Site 0533)
state: London, City Of
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital ( Site 0524)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: