Myeloproliferative Neoplasms Clinical Trial
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
Summary
A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
View Eligibility Criteria
Eligibility Criteria
Inclusion Criteria:
Aged ≥ 18 years
Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)
Adequate hematologic, renal, and hepatic function
Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0
Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system
Spleen volume of ≥ 450 cm^3
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion Criteria:
Splenectomy or splenic irradiation in the previous 6 months
Chronic or active conditions and/or concomitant medication use that would prohibit treatment
Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm
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There are 124 Locations for this study
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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Birmingham Alabama, 35294, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler Arizona, 85224, United States
Chandler Arizona, 85224, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
La Jolla California, 92093, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
UCLA Medical Center
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Yale University School of Medicine
New Haven Connecticut, 06510, United States
New Haven Connecticut, 06510, United States
Georgetown University
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20007, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Jacksonville Florida, 32224, United States
University of Miami Hospital
Miami Florida, 33136, United States
Miami Florida, 33136, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Tampa Florida, 33612, United States
Northwestern
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Chicago Illinois, 60637, United States
Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Loyola University - Cardinal Bernardin Cancer Center
Maywood Illinois, 60153, United States
Maywood Illinois, 60153, United States
Franciscan Health/Indiana blood and Marrow Transplantation
Indianapolis Indiana, 46237, United States
Indianapolis Indiana, 46237, United States
Norton Cancer Institute, St. Matthews Campus
Louisville Kentucky, 40207, United States
Louisville Kentucky, 40207, United States
University of Michigan Medical Center
Ann Arbor Michigan, 48109, United States
Ann Arbor Michigan, 48109, United States
Washington University
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Cancer Care Specialists
Reno Nevada, 89511, United States
Reno Nevada, 89511, United States
Summit Medical Group - Cancer Center
Florham Park New Jersey, 07932, United States
Florham Park New Jersey, 07932, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
New York New York, 10065, United States
Weill Cornell Medical College- New York Presbyterian Hospital
New York New York, 10065, United States
New York New York, 10065, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Cleveland Ohio, 44195, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Portland Oregon, 97239, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Mays Cancer Center at UT Health San Antonio MD Anderson
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Sydney Adventist Hospital
Wahroonga New South Wales, 2076, Australia
Wahroonga New South Wales, 2076, Australia
Icon Cancer Centre
Brisbane Queensland, 4101, Australia
Brisbane Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Adelaide South Australia, 5000, Australia
Monash Health
Clayton Victoria, 3168, Australia
Clayton Victoria, 3168, Australia
Peninsula Private Hospital Clinical Trials Unit
Frankston Victoria, 3199, Australia
Frankston Victoria, 3199, Australia
USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic
Buderim , QLD 4, Australia
Buderim , QLD 4, Australia
One Clinical Research PTY LTD
Nedlands , 6009, Australia
Nedlands , 6009, Australia
Calvary North Adelaide Hospital
North Adelaide , , Australia
North Adelaide , , Australia
LKH - Universitätsklinikum Graz; Abteilung für Hämatologie
Graz , A-803, Austria
Graz , A-803, Austria
Krankenhaus der Elisabethinen Linz
Linz , 4020, Austria
Linz , 4020, Austria
ZNA
Antwerpen , , Belgium
Antwerpen , , Belgium
AZ Sint-Jan
Brugge , , Belgium
Brugge , , Belgium
Cliniques universitaires Saint-Luc
Brussel , 1200, Belgium
Brussel , 1200, Belgium
UZ Brussel
Jette , 1090, Belgium
Jette , 1090, Belgium
Hôpital de Jolimont
La Louvière , 7100, Belgium
La Louvière , 7100, Belgium
UZ Leuven
Leuven , , Belgium
Leuven , , Belgium
Domaine Universitaire du Sart Tilman
Liège , 4000, Belgium
Liège , 4000, Belgium
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Calgary Alberta, T2N 4, Canada
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada
Edmonton Alberta, T6G 2, Canada
London Health Sciences Center - Victoria Hospital
London Ontario, N6A 5, Canada
London Ontario, N6A 5, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 2, Canada
Toronto Ontario, M5G 2, Canada
Jewish General Hospital
Montréal Quebec, H3T 1, Canada
Montréal Quebec, H3T 1, Canada
Hôpital Maisonneuve-Rosemont
Montréal , H1T 2, Canada
Montréal , H1T 2, Canada
The Ottawa Hospital General Campus
Ottawa , K1H 8, Canada
Ottawa , K1H 8, Canada
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Hradec Kralove , 500 0, Czechia
University Hospital Olomouc
Olomouc , 779 0, Czechia
Olomouc , 779 0, Czechia
CHU Amiens Picardie
Amiens , 80054, France
Amiens , 80054, France
CHU Henri-Mondor
Créteil , 94010, France
Créteil , 94010, France
CHU Henri-Mondor
Créteil , 94010, France
Créteil , 94010, France
Centre Hospitalier
Le Mans , 72000, France
Le Mans , 72000, France
Hopital de la Conception
Marseille , 13385, France
Marseille , 13385, France
Hôpital l'Archet 1
Nice , 06202, France
Nice , 06202, France
CHU DE NIMES _Institut de Cancérologie du Gard
Nîmes , , France
Nîmes , , France
Centre d'Investigations Cliniques
Paris , , France
Paris , , France
Centre Hospitalier Lyon Sud Secteur 1G
Pierre-Bénite , 69310, France
Pierre-Bénite , 69310, France
Chu Pontchaillou - Service Hematologie
Rennes , 35033, France
Rennes , 35033, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez , 42271, France
Saint-Priest-en-Jarez , 42271, France
Hôpital Bretonneau
Tours , 37044, France
Tours , 37044, France
Chru Brabois
Vandœuvre-lès-Nancy , 54500, France
Vandœuvre-lès-Nancy , 54500, France
Universitätsklinikum Ulm
Ulm Baden-Württemberg, 89081, Germany
Ulm Baden-Württemberg, 89081, Germany
Hämatologisch-Onkologische Praxis Augsburg
Augsburg Bayern, 86151, Germany
Augsburg Bayern, 86151, Germany
Johannes Wesling Klinikum Minden
Minden Nordrhein-Westfalen, 32429, Germany
Minden Nordrhein-Westfalen, 32429, Germany
Klinikum Chemnitz, Innere Medizin III
Chemnitz Sachsen, 09116, Germany
Chemnitz Sachsen, 09116, Germany
Universitätsklinikum Halle (Saale), Krukenberg-Krebszentrum Halle (KKH)
Halle Sachsen, 06120, Germany
Halle Sachsen, 06120, Germany
Universitätsklinikum Jena, Klinik für Innere Medizin II
Jena Thüringen, 07747, Germany
Jena Thüringen, 07747, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE), II. Medizinische Klinik und Poliklinik
Hamburg , 20251, Germany
Hamburg , 20251, Germany
University Hospital of Alexandroupolis
Alexandroupolis , , Greece
Alexandroupolis , , Greece
General Hospital, School of Medicine National and Kapodistrian University of Athens
Athens , , Greece
Athens , , Greece
Laiko General Hospital
Athens , , Greece
Athens , , Greece
Ηippokration General Hospital
Athens , , Greece
Athens , , Greece
Princess Margaret Hospital
Hong Kong Kowloon, , Hong Kong
Hong Kong Kowloon, , Hong Kong
Prince of Wales Hospital
Hong Kong New Territories, , Hong Kong
Hong Kong New Territories, , Hong Kong
: Pecs University, 1st Department of Medicine
Pécs Pecs, 7624, Hungary
Pécs Pecs, 7624, Hungary
Semmelweis University - Internal Medicine and Oncology Clinic
Budapest , 1088, Hungary
Budapest , 1088, Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia
Debrecen , 4032, Hungary
Debrecen , 4032, Hungary
Petz Aladar Egyetemi Oktato Korhaz
Gyor , 9024, Hungary
Gyor , 9024, Hungary
Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia
Nyíregyháza , , Hungary
Nyíregyháza , , Hungary
Barzilai Medical Center
Ashkelon , 78306, Israel
Ashkelon , 78306, Israel
Soroka Medical Center
Be'er Sheva , 84101, Israel
Be'er Sheva , 84101, Israel
Shamir Medical Center
Be'er Ya'aqov , 60930, Israel
Be'er Ya'aqov , 60930, Israel
Rambam Health Corporation
Haifa , 31096, Israel
Haifa , 31096, Israel
Lady Davis Carmel Medical Center
Haifa , 34362, Israel
Haifa , 34362, Israel
Wolfson Medical Center
H̱olon , Itayz, Israel
H̱olon , Itayz, Israel
Wolfson Medical Center
H̱olon , , Israel
H̱olon , , Israel
Shaarei Zedek
Jerusalem , 91031, Israel
Jerusalem , 91031, Israel
Hadassah University Hospital-Ein Kerem
Jerusalem , 95903, Israel
Jerusalem , 95903, Israel
Shaarei Zedek
Nahariya , 22100, Israel
Nahariya , 22100, Israel
Rabin Medical Center - Beilinson Campus,
Petah Tikva , 49100, Israel
Petah Tikva , 49100, Israel
Sheba Medical Center
Ramat Gan , 52656, Israel
Ramat Gan , 52656, Israel
Kaplan Medical Center
Reẖovot , 76100, Israel
Reẖovot , 76100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Tel Aviv , 64239, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo , 24127, Italy
Bergamo , 24127, Italy
A.O.U. Policlinico S. Orsola-Malpighi
Bologna , 40138, Italy
Bologna , 40138, Italy
AOU Policlinico G. Rodolico - San Marco
Catania , , Italy
Catania , , Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara , , Italy
Ferrara , , Italy
Azienda Ospedaliera Universitaria Careggi
Florence , , Italy
Florence , , Italy
Ospedale Policlinico San Martino IRCCS
Genova , , Italy
Genova , , Italy
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola , , Italy
Meldola , , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano , , Italy
Milano , , Italy
Azienda Ospedaliera San Gerardo di Monza
Monza , , Italy
Monza , , Italy
AOU S.Luigi Gonzaga
Orbassano , , Italy
Orbassano , , Italy
Ospedale Sant'Eugenio
Rome , , Italy
Rome , , Italy
Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi
Varese , , Italy
Varese , , Italy
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Gyeongsang National University Hospital
Jinju-si Gyeongsangnam-do, , Korea, Republic of
Jinju-si Gyeongsangnam-do, , Korea, Republic of
Inje University Haeundae Paik Hospital
Busan , 48108, Korea, Republic of
Busan , 48108, Korea, Republic of
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Busan , 49241, Korea, Republic of
Inje University Busan Paik Hospital
Busan , , Korea, Republic of
Busan , , Korea, Republic of
Kyungpook National University Hospital
Daegu , 41944, Korea, Republic of
Daegu , 41944, Korea, Republic of
Daegu Catholic University Medical Center
Daegu , , Korea, Republic of
Daegu , , Korea, Republic of
Keimyung University Dongsan Hospital
Daegu , , Korea, Republic of
Daegu , , Korea, Republic of
Cha Bundang Medical Center Cha University
Gyeonggi-do , , Korea, Republic of
Gyeonggi-do , , Korea, Republic of
The Catholic University Of Korea St. Vincent Hospital
Gyeonggi-do , , Korea, Republic of
Gyeonggi-do , , Korea, Republic of
Gachon University Gil Medical Center
Incheon , , Korea, Republic of
Incheon , , Korea, Republic of
Jeonbuk National University Hospital
Jeonju , 54907, Korea, Republic of
Jeonju , 54907, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Seoul , 03722, Korea, Republic of
Korea University Guro Hospital
Seoul , 08307, Korea, Republic of
Seoul , 08307, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Hanyang University Medical Center
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Korea University Anam Hospital
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
The Catholic University of Korea
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
The Catholic University of South Korea Seoul St. Mary's Hospital
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Ulsan University Hospital
Ulsan , , Korea, Republic of
Ulsan , , Korea, Republic of
Hospital Sultanah Aminah
Johor Bahru Johor, 80100, Malaysia
Johor Bahru Johor, 80100, Malaysia
Hospital Sultanah Bahiyah
Alor Setar Kedah, 05460, Malaysia
Alor Setar Kedah, 05460, Malaysia
Hospital Pulau Pinang
George Town Penang, 10450, Malaysia
George Town Penang, 10450, Malaysia
:Hospital Ampang
Ampang Selangor, 68000, Malaysia
Ampang Selangor, 68000, Malaysia
Sunway Medical Centre
Petaling Jaya Selangor, 47500, Malaysia
Petaling Jaya Selangor, 47500, Malaysia
University Malaya Medical Centre
Kuala Lumpur , 59100, Malaysia
Kuala Lumpur , 59100, Malaysia
Amsterdam UMC
Amsterdam , 1081, Netherlands
Amsterdam , 1081, Netherlands
Maastricht University Medical Center
Maastricht , 6229 , Netherlands
Maastricht , 6229 , Netherlands
Wojewódzki Szpital Specjalistyczny w Bialej Podlaskiej
Biała Podlaska , 21-50, Poland
Biała Podlaska , 21-50, Poland
Uniwersyteckie Centrum Kliniczne
Gdańsk , 80-29, Poland
Gdańsk , 80-29, Poland
Pratia Onkologia Katowice
Katowice , , Poland
Katowice , , Poland
Centrum Medyczne Pratia
Skorzewo , 60-18, Poland
Skorzewo , 60-18, Poland
Nasz Lekarz Przychodnie Medyczne
Toruń , 87-10, Poland
Toruń , 87-10, Poland
Hospital Universitario Central de Asturias
Oviedo Asturias, 33011, Spain
Oviedo Asturias, 33011, Spain
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona , 8916, Spain
Badalona , 8916, Spain
Hospital Clinic de Barcelona
Barcelona , , Spain
Barcelona , , Spain
Vall d'Hebron Institute of Oncology
Barcelona , , Spain
Barcelona , , Spain
Hospital Universitario De Burgos
Burgos , 09006, Spain
Burgos , 09006, Spain
Hospital San Pedro de Alcantara
Caceres , 10003, Spain
Caceres , 10003, Spain
ICO Girona - Hospital Universitari de Girona
Girona , , Spain
Girona , , Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria , 35010, Spain
Las Palmas de Gran Canaria , 35010, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid , 28040, Spain
Madrid , 28040, Spain
Complejo Hospitalario de Navarra
Pamplona , 31008, Spain
Pamplona , 31008, Spain
Hospital Universitario de Salamanc
Salamanca , 37007, Spain
Salamanca , 37007, Spain
Hospital Virgen Macarena
Sevilla , , Spain
Sevilla , , Spain
Hospital Clínico Universitario de Valencia
Valencia , 46010, Spain
Valencia , 46010, Spain
Chang Gung Memorial Hospital Chiayi
Chiayi City , , Taiwan
Chiayi City , , Taiwan
China Medical University Hospital
Chiayi City , , Taiwan
Chiayi City , , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , , Taiwan
Kaohsiung , , Taiwan
Taichung Veterans General Hospital
Taichung , , Taiwan
Taichung , , Taiwan
National Taiwan University Hospital
Taipei , , Taiwan
Taipei , , Taiwan
Songklanagarind Hospital
Songkla Hat Yai District, 90110, Thailand
Songkla Hat Yai District, 90110, Thailand
Chulabhorn Hospital
Bangkok Lak Si, 10210, Thailand
Bangkok Lak Si, 10210, Thailand
Srinagarind hospital,Khon Kaen University
Khon Kaen Mueang Khon Kaen District, 40002, Thailand
Khon Kaen Mueang Khon Kaen District, 40002, Thailand
King Chulalongkorn Memorial Hospital
Bangkok Pathumwan, 10330, Thailand
Bangkok Pathumwan, 10330, Thailand
Rajavithi Hospital
Bangkok Ratchathewi District, 10400, Thailand
Bangkok Ratchathewi District, 10400, Thailand
Ankara University Faculty of Medicine Cebeci Research and Application Hospital
Ankara , , Turkey
Ankara , , Turkey
Dr. Abdurrahman Yurtaslan Oncology Health Application and Research Center
Ankara , , Turkey
Ankara , , Turkey
Antalya Medstar Hospital
Antalya , , Turkey
Antalya , , Turkey
Edirne Trakya University Faculty of Medicine Hospital
Edirne , , Turkey
Edirne , , Turkey
Gaziantep University Sahinbey Research and Application Center Hospital
Gaziantep , , Turkey
Gaziantep , , Turkey
Izmir Ege University Faculty of Medicine Hospital
İzmir , , Turkey
İzmir , , Turkey
Kocaeli University Application
Kocaeli , , Turkey
Kocaeli , , Turkey
Mersin University
Mersin , , Turkey
Mersin , , Turkey
Samsun 19 Mayıs University Health Application Research Hospital
Samsun , , Turkey
Samsun , , Turkey
Western General Hospital
Edinburgh Scotland, EH4 2, United Kingdom
Edinburgh Scotland, EH4 2, United Kingdom
University Hospital of Wales
Cardiff Wales, CF14 , United Kingdom
Cardiff Wales, CF14 , United Kingdom
Pilgrim Hospital
Boston , PE21 , United Kingdom
Boston , PE21 , United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge , CB2 0, United Kingdom
Cambridge , CB2 0, United Kingdom
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London , W12 0, United Kingdom
London , W12 0, United Kingdom
University College London Hospitals
London , , United Kingdom
London , , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Department of Haematology, Cancer and Haematology Centre, Churchill Hospital
Oxford , , United Kingdom
Oxford , , United Kingdom
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