Phase
Condition
Thrombosis
Platelet Disorders
Leukemia (Pediatric)
Treatment
Hydroxyurea placebo
Bomedemstat placebo
Hydroxyurea
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of Essential Thrombocythemia (ET) based on World Health OrganizationCriteria for myeloproliferative neoplasms, and an indication for cytoreductivetherapy regardless of age or risk status
Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per amodified 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 onantiretroviral therapy
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeksand have undetectable HBV viral load
Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCVviral load is undetectable
Exclusion
Exclusion Criteria:
History of any illness/impairment of gastrointestinal function that might interferewith drug absorption
History of a malignancy, unless potentially curative treatment has been completedwith no evidence of malignancy for 2 years
HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease
Has an active infection requiring systemic therapy
Has had a major surgery <4 weeks prior to first dose of study intervention or hasnot recovered from side effects of major surgery >4 weeks prior to first dose
Study Design
Connect with a study center
Hospital Universitario Austral ( Site 0101)
Pilar, Buenos Aires B1629AHJ
ArgentinaActive - Recruiting
Hospital Italiano de Buenos Aires ( Site 0102)
ABB, Caba C1199ABB
ArgentinaActive - Recruiting
C.I.C.E. 9 de Julio ( Site 0104)
San Miguel de Tucumán, Tucuman T4000IKO
ArgentinaActive - Recruiting
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105)
Santa Fe, S3000BPJ
ArgentinaActive - Recruiting
Westmead Hospital ( Site 0201)
Westmead, New South Wales 2115
AustraliaActive - Recruiting
Westmead Hospital-The Crown Princess Mary Cancer Care Centre ( Site 0201)
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203)
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Monash Health-Haematology Research ( Site 0202)
Clayton, Victoria 3168
AustraliaActive - Recruiting
Austin Health-Cancer Clinical Trials Centre ( Site 0206)
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Royal Perth Hospital-Haematology ( Site 0204)
Perth, Western Australia 6000
AustraliaActive - Recruiting
Ordensklinikum Linz GmbH Elisabethinen ( Site 0562)
Linz, Oberosterreich 4020
AustriaActive - Recruiting
Biocenter ( Site 0149)
Concepcion, Biobio 4070196
ChileActive - Recruiting
IC La Serena Research ( Site 0150)
La Serena, Coquimbo 1720430
ChileSite Not Available
IC La Serena Research ( Site 0150)
La Serena., Coquimbo 1720430
ChileActive - Recruiting
Bradfordhill-Clinical Area ( Site 0142)
Santiago, Region M. De Santiago 8420383
ChileActive - Recruiting
Clínica Alemana de Santiago ( Site 0143)
Santiago, Region M. De Santiago 7650568
ChileActive - Recruiting
Clínica Inmunocel ( Site 0147)
Santiago, Region M. De Santiago 7580206
ChileActive - Recruiting
FALP-UIDO ( Site 0148)
Santiago, Region M. De Santiago 7500921
ChileActive - Recruiting
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0164)
Medellín, Antioquia 050030
ColombiaActive - Recruiting
IMAT S.A.S ( Site 0162)
Monteria, Cordoba 230002
ColombiaActive - Recruiting
Oncomédica S.A.S ( Site 0162)
Monteria, Cordoba 230002
ColombiaActive - Recruiting
Los Cobos Medical Center ( Site 0165)
Bogota, Distrito Capital De Bogota 110121
ColombiaActive - Recruiting
Rigshospitalet-Hematology - CTU ( Site 0321)
Copenhagen, Hovedstaden 2100
DenmarkActive - Recruiting
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324)
Aarhus, Midtjylland 8200
DenmarkActive - Recruiting
Roskilde Sygehus-Department of Hematology ( Site 0323)
Roskilde, Sjaelland 4000
DenmarkActive - Recruiting
Odense Universitetshospital-Department of Hematology ( Site 0325)
Odense C, Syddanmark 5000
DenmarkActive - Recruiting
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology ( Site 0349)
Nice, Alpes-Maritimes 06202
FranceActive - Recruiting
CHU Bordeaux Haut-Leveque-service de mèdecine interne et maladies infectieuses ( Site 0346)
Pessac, Aquitaine 33600
FranceActive - Recruiting
Hôpital de la Conception ( Site 0351)
Marseille, Bouches-du-Rhone 13005
FranceActive - Recruiting
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0352)
Toulouse, Haute-Garonne 31059
FranceActive - Recruiting
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0344)
Limoges, Haute-Vienne 87042
FranceActive - Recruiting
Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Si
Tours, Indre-et-Loire 37000
FranceActive - Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0347)
Nantes, Loire-Atlantique 44000
FranceActive - Recruiting
centre hospitalier lyon sud ( Site 0343)
Pierre-Bénite, Rhone 69310
FranceActive - Recruiting
HENRI MONDOR HOSPITAL ( Site 0348)
Creteil, Val-de-Marne 94010
FranceActive - Recruiting
Hopital Saint-Louis ( Site 0341)
Paris, 75010
FranceActive - Recruiting
VK&K Studien GbR ( Site 0370)
Landshut, Bayern 84036
GermanyActive - Recruiting
Universitätsklinikum Aachen ( Site 0367)
Aachen, Nordrhein-Westfalen 52074
GermanyActive - Recruiting
Universitaetsklinikum Essen ( Site 0366)
Essen, Nordrhein-Westfalen 45147
GermanyActive - Recruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Sit
Mainz, Rheinland-Pfalz 55131
GermanyActive - Recruiting
Universitätsklinikum Halle ( Site 0361)
Halle, Sachsen-Anhalt 06120
GermanyActive - Recruiting
Universitätsklinikum Jena-Klinik für Innere Medizin II, Abt. Hämatologie und Internistische Onkolog
Jena, Thuringen 07747
GermanyActive - Recruiting
Queen Mary Hospital ( Site 0221)
Hksar,
Hong KongActive - Recruiting
Petz Aladar Egyetemi Oktato Korhaz-Hematológia ( Site 0405)
Gyor, Gyor-Moson-Sopron 9024
HungaryActive - Recruiting
Somogy Vármegyei Kaposi Mór Oktató Kórház-Haematológiai osztály ( Site 0406)
Kaposvár, Somogy 7400
HungaryActive - Recruiting
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0404)
Nyiregyhaza, Szabolcs-Szatmar-Bereg 4400
HungaryActive - Recruiting
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
Debrecen, 4032
HungaryActive - Recruiting
Soroka Medical Center ( Site 0427)
Be'er Sheva, 8410101
IsraelActive - Recruiting
Carmel Hospital ( Site 0426)
Haifa, 3436212
IsraelActive - Recruiting
Rambam Health Care Campus ( Site 0429)
Haifa, 3109601
IsraelActive - Recruiting
Hadassah Medical Center ( Site 0424)
Jerusalem, 9112001
IsraelActive - Recruiting
Rabin Medical Center ( Site 0425)
Petah Tikva, 4941492
IsraelActive - Recruiting
Sheba Medical Center ( Site 0428)
Ramat Gan, 5265601
IsraelActive - Recruiting
Sourasky Medical Center ( Site 0422)
Tel Aviv, 6423906
IsraelActive - Recruiting
Yitzhak Shamir Medical Center. ( Site 0421)
Zerifin, 70300
IsraelActive - Recruiting
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0443)
Alessandria, Ancona 15121
ItalyActive - Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0447)
Milano, Lombardia 20122
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Careggi ( Site 0441)
Firenze, Toscana 50134
ItalyActive - Recruiting
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo ( Site 0443)
Alessandria, 15121
ItalyActive - Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0446)
Bologna, 40138
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0444)
Pavia, 27100
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (
Roma, 00168
ItalyActive - Recruiting
Ospedale di Circolo e Fondazione Macchi Varese ( Site 0442)
Varese, 21100
ItalyActive - Recruiting
Fujita Health University ( Site 0613)
Toyoake, Aichi 470-1192
JapanActive - Recruiting
Fujita Health University Hospital ( Site 0613)
Toyoake, Aichi 470-1192
JapanActive - Recruiting
Ehime University Hospital ( Site 0612)
Toon, Ehime 791-0295
JapanActive - Recruiting
Hokkaido University Hospital ( Site 0601)
Sapporo, Hokkaido 060-8648
JapanActive - Recruiting
Kobe City Medical Center General Hospital ( Site 0603)
Kobe, Hyogo 650-0047
JapanActive - Recruiting
Kanazawa University Hospital ( Site 0614)
Kanazawa, Ishikawa 920-8641
JapanActive - Recruiting
Mie University Hospital ( Site 0615)
Tsu, Mie 514-8507
JapanActive - Recruiting
National Hospital Organization Sendai Medical Center ( Site 0617)
Sendai, Miyagi 983-8520
JapanActive - Recruiting
Kansai Medical University Hospital ( Site 0607)
Hirakata, Osaka 573-1191
JapanActive - Recruiting
Kindai University Hospital ( Site 0600)
Osakasayama, Osaka 589-8511
JapanActive - Recruiting
Kindai University Hospital- Osakasayama Campus-Hematology and Rheumatology ( Site 0600)
Osakasayama, Osaka 589-8511
JapanActive - Recruiting
Juntendo University Hospital ( Site 0611)
Bunkyo-ku, Tokyo 113-8431
JapanActive - Recruiting
University of Yamanashi Hospital ( Site 0606)
Chuo, Yamanashi 409-3898
JapanActive - Recruiting
Kyushu University Hospital ( Site 0605)
Fukuoka, 812-8582
JapanActive - Recruiting
Fukushima Medical University ( Site 0616)
Fukushima, 960-1295
JapanActive - Recruiting
Fukushima Medical University Hospital ( Site 0616)
Fukushima, 960-1295
JapanActive - Recruiting
University of Miyazaki Hospital ( Site 0609)
Miyazaki, 889-1692
JapanActive - Recruiting
Okayama University Hospital ( Site 0604)
Okayama, 700-8558
JapanActive - Recruiting
Nippon Medical School Hospital ( Site 0608)
Tokyo, 113-8603
JapanActive - Recruiting
Medivest Centro de Investigación Integral ( Site 0183)
Chihuahua City, Chihuahua 31203
MexicoActive - Recruiting
Higiea Oncologia ( Site 0184)
Mexico City, Distrito Federal 11819
MexicoActive - Recruiting
Centro de Investigacion Clinica de Oaxaca ( Site 0181)
Oaxaca de Juarez, Oaxaca 68020
MexicoSite Not Available
Centro de Investigacion Clinica de Oaxaca ( Site 0181)
Oaxaca de Juarez., Oaxaca 68020
MexicoActive - Recruiting
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp
Lublin, Lubelskie 20-081
PolandActive - Recruiting
Pratia Onkologia Katowice ( Site 0461)
Katowice, Slaskie 40-519
PolandActive - Recruiting
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S
Kielce, Swietokrzyskie 25-734
PolandActive - Recruiting
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0490)
Badalona, Barcelona 08916
SpainActive - Recruiting
Hospital Universitario Marqués de Valdecilla-Haematology ( Site 0486)
Santander, Cantabria 39008
SpainActive - Recruiting
HOSPITAL CLÍNIC DE BARCELONA ( Site 0481)
Barcelona, Cataluna 08036
SpainActive - Recruiting
Institut Català d'Oncologia - L'Hospitalet ( Site 0482)
L'Hospitalet de Llobregat, Cataluna 08908
SpainActive - Recruiting
Clinica Universidad de Navarra-Hematology Department ( Site 0485)
Madrid, Madrid, Comunidad De 28027
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal-Hematology ( Site 0484)
Madrid, Madrid, Comunidad De 28034
SpainActive - Recruiting
Hospital Costa del Sol-Hematology Service ( Site 0493)
Marbella, Malaga 29603
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0489)
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario 12 de Octubre ( Site 0494)
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( S
Salamanca, 37007
SpainActive - Recruiting
Universitetssjukhuset Örebro ( Site 0542)
Örebro, Orebro Lan 701 85
SwedenActive - Recruiting
Skånes Universitetssjukhus Lund-Department of Hematology ( Site 0544)
Lund, Skane Lan 22185
SwedenActive - Recruiting
Karolinska Universitetssjukhuset Huddinge ( Site 0541)
Huddinge, Stockholms Lan 141 86
SwedenActive - Recruiting
Akademiska sjukhuset ( Site 0545)
Uppsala, Uppsala Lan 751 85
SwedenActive - Recruiting
Sahlgrenska Universitetssjukhuset-Department of hematology and coagulation ( Site 0543)
Gothenburg, Vastra Gotalands Lan 413 45
SwedenActive - Recruiting
Chang Gung Memorial Hospital- Chiayi ( Site 0242)
Chiayi City, Chiayi 613
TaiwanActive - Recruiting
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0245)
Tainan, 704
TaiwanActive - Recruiting
National Taiwan University Hospital ( Site 0241)
Taipei, 10002
TaiwanActive - Recruiting
Chang Gung Medical Foundation-Linkou Branch ( Site 0243)
Taoyuan, 33305
TaiwanActive - Recruiting
Glan Clwyd Hospital ( Site 0528)
Bodelwyddan, Denbighshire LL18 5UJ
United KingdomActive - Recruiting
Royal Gwent Hospital ( Site 0524)
Gwent, Newport NP20 2UB
United KingdomActive - Recruiting
Stanford Cancer Center ( Site 0024)
Palo Alto, California 94304
United StatesActive - Recruiting
Exempla Lutheran Medical Center ( Site 0014)
Golden, Colorado 80401
United StatesActive - Recruiting
Parkview Research Center at Parkview Regional Medical Center ( Site 0006)
Fort Wayne, Indiana 46845
United StatesCompleted
Duke University Health System (DUHS) ( Site 0012)
Durham, North Carolina 27710
United StatesActive - Recruiting
Oregon Health & Science University ( Site 0018)
Portland, Oregon 97239
United StatesActive - Recruiting
University of Virginia ( Site 0020)
Charlottesville, Virginia 22908
United StatesActive - Recruiting
VCU Health Adult Outpatient Pavillion ( Site 0008)
Richmond, Virginia 23219
United StatesActive - Recruiting
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