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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

430

Study ID:

NCT04603495

Recruitment Status:

Active, not recruiting

Sponsor:

Constellation Pharmaceuticals

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There are 111 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler Arizona, 85224, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
UCLA Medical Center
Los Angeles California, 90095, United States
Yale University School of Medicine
New Haven Connecticut, 06510, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL
Decatur Illinois, 62526, United States
Franciscan Health/Indiana blood and Marrow Transplantation
Indianapolis Indiana, 46237, United States
Norton Cancer Institute, St. Matthews Campus
Louisville Kentucky, 40207, United States
University of Michigan Medical Center
Ann Arbor Michigan, 48109, United States
Washington University
Saint Louis Missouri, 63110, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Weill Cornell Medical College- New York Presbyterian Hospital
New York New York, 10065, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Texas Health Science Center - San Antonio
San Antonio Texas, 78229, United States
Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute
Seattle Washington, 98104, United States
Icon Cancer Centre
Brisbane Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Monash Health
Clayton Victoria, 3168, Australia
Peninsula Private Hospital Clinical Trials Unit
Frankston Victoria, 3199, Australia
USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic
Buderim , QLD 4, Australia
One Clinical Research PTY LTD
Nedlands , 6009, Australia
LKH - Universitätsklinikum Graz; Abteilung für Hämatologie
Graz , A-803, Austria
Krankenhaus der Elisabethinen Linz
Linz , 4020, Austria
Kepler University Hospital
Linz , 4021, Austria
University Hospital Salzburg
Salzburg , 5020, Austria
ZNA
Antwerpen , , Belgium
Cliniques universitaires Saint-Luc
Brussel , 1200, Belgium
Hôpital de Jolimont
La Louvière , 7100, Belgium
UZ Leuven
Leuven , , Belgium
Domaine Universitaire du Sart Tilman
Liège , 4000, Belgium
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada
London Health Sciences Center - Victoria Hospital
London Ontario, N6A 5, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 2, Canada
Jewish General Hospital
Montréal Quebec, H3T 1, Canada
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
University Hospital Olomouc
Olomouc , 779 0, Czechia
Amiens South Hospital univerisy - Hopital Sud
Amiens , 80054, France
Centre Hospitalier
Le Mans , 72000, France
Hôpital l'Archet 1
Nice , 06202, France
Gard Cancer Institute
Nîmes , 30029, France
Centre Hospitalier Lyon Sud Secteur 1G
Pierre-Bénite , 69310, France
Chu Pontchaillou - Service Hematologie
Rennes , 35033, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez , 42271, France
Hôpital Bretonneau
Tours , 37044, France
Chru Brabois
Vandœuvre-lès-Nancy , 54500, France
Universitätsklinikum Ulm
Ulm Baden-Württemberg, 89081, Germany
Hämatologisch-Onkologische Praxis Augsburg
Augsburg Bayern, 86151, Germany
Universitätsklinikum Halle (Saale), Krukenberg-Krebszentrum Halle (KKH)
Halle Sachsen, 06120, Germany
Universitätsklinikum Jena, Klinik für Innere Medizin II
Jena Thüringen, 07747, Germany
University Hospital Hamburg-Eppendorf
Hamburg , 20246, Germany
Laiko General Hospital
Athens , , Greece
UGH of Ioannina
Ioánnina , 455 0, Greece
University General Hospital of Patras
Río , 26504, Greece
Princess Margaret Hospital
Hong Kong Kowloon, , Hong Kong
Prince of Wales Hospital
Hong Kong New Territories, , Hong Kong
: Pecs University, 1st Department of Medicine
Pécs Pecs, 7624, Hungary
Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia
Nyíregyháza , , Hungary
Soroka Medical Center
Be'er Sheva , 84101, Israel
Shamir Medical Center
Be'er Ya'aqov , 60930, Israel
Rambam Health Corporation
Haifa , 31096, Israel
Lady Davis Carmel Medical Center
Haifa , 34362, Israel
Wolfson Medical Center
H̱olon , , Israel
Hadassah University Hospital-Ein Kerem
Jerusalem , 95903, Israel
Shaarei Zedek
Nahariya , 22100, Israel
Rabin Medical Center - Beilinson Campus,
Petah Tikva , 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo , 24127, Italy
A.O.U. Policlinico S. Orsola-Malpighi
Bologna , 40138, Italy
Regional Hospital Spedali Civili di Brescia
Brescia , 25123, Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara , , Italy
Azienda Ospedaliera Universitaria Careggi
Florence , , Italy
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola , , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano , , Italy
Azienda Ospedaliera San Gerardo di Monza
Monza , , Italy
University Hospital Maggiore della Carità
Novara , 28100, Italy
AOU S.Luigi Gonzaga
Orbassano , , Italy
University Hospital of Padova
Padova , 35128, Italy
University Hospital 'Paolo Giaccone' Polyclinic
Palermo , 90127, Italy
Ospedale Sant'Eugenio
Rome , , Italy
Hospital Ordine Mauriziano of Turin
Turin , 10128, Italy
Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi
Varese , , Italy
Gyeongsang National University Hospital
Jinju-si Gyeongsangnam-do, , Korea, Republic of
Inje University Haeundae Paik Hospital
Busan , 48108, Korea, Republic of
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Inje University Busan Paik Hospital
Busan , , Korea, Republic of
Kyungpook National University Hospital
Daegu , 41944, Korea, Republic of
Daegu Catholic University Medical Center
Daegu , , Korea, Republic of
The Catholic University Of Korea St. Vincent Hospital
Gyeonggi-do , , Korea, Republic of
Gachon University Gil Medical Center
Incheon , , Korea, Republic of
Jeonbuk National University Hospital
Jeonju , 54907, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Korea University Anam Hospital
Seoul , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
The Catholic University of Korea
Seoul , , Korea, Republic of
The Catholic University of South Korea Seoul St. Mary's Hospital
Seoul , , Korea, Republic of
Ulsan University Hospital
Ulsan , , Korea, Republic of
Hospital Sultanah Aminah
Johor Bahru Johor, 80100, Malaysia
Hospital Sultanah Bahiyah
Alor Setar Kedah, 05460, Malaysia
Hospital Pulau Pinang
George Town Penang, 10450, Malaysia
:Hospital Ampang
Ampang Selangor, 68000, Malaysia
Sunway Medical Centre
Petaling Jaya Selangor, 47500, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu , 88586, Malaysia
Amsterdam UMC
Amsterdam , 1081, Netherlands
Maastricht University Medical Center
Maastricht , 6229 , Netherlands
Wojewódzki Szpital Specjalistyczny w Bialej Podlaskiej
Biała Podlaska , 21-50, Poland
Uniwersyteckie Centrum Kliniczne
Gdańsk , 80-29, Poland
Pratia Onkologia Katowice
Katowice , , Poland
Centrum Medyczne Pratia
Skorzewo , 60-18, Poland
Nasz Lekarz Przychodnie Medyczne
Toruń , 87-10, Poland
Hospital Universitario Central de Asturias
Oviedo Asturias, 33011, Spain
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona , 8916, Spain
Hospital Clinic de Barcelona
Barcelona , , Spain
Vall d'Hebron Institute of Oncology
Barcelona , , Spain
Hospital San Pedro de Alcantara
Caceres , 10003, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria , 35010, Spain
Quirónsalud Madrid University Hospital
Madrid , 28223, Spain
Morales Meseguer General University Hospital
Murcia , 30008, Spain
Hospital Universitario de Salamanc
Salamanca , 37007, Spain
Hospital Virgen Macarena
Sevilla , , Spain
University Hospital of Toledo
Toledo , 45007, Spain
Hospital Clínico Universitario de Valencia
Valencia , 46010, Spain
Chang Gung Memorial Hospital Chiayi
Chiayi City , , Taiwan
China Medical University Hospital
Chiayi City , , Taiwan
Taichung Veterans General Hospital
Taichung , , Taiwan
National Taiwan University Hospital
Taipei , , Taiwan
Songklanagarind Hospital
Songkla Hat Yai District, 90110, Thailand
Chulabhorn Hospital
Bangkok Lak Si, 10210, Thailand
Srinagarind hospital,Khon Kaen University
Khon Kaen Mueang Khon Kaen District, 40002, Thailand
King Chulalongkorn Memorial Hospital
Bangkok Pathumwan, 10330, Thailand
Rajavithi Hospital
Bangkok Ratchathewi District, 10400, Thailand
Ankara University Faculty of Medicine Cebeci Research and Application Hospital
Ankara , , Turkey
Dr. Abdurrahman Yurtaslan Oncology Health Application and Research Center
Ankara , , Turkey
Antalya Medstar Hospital
Antalya , , Turkey
Edirne Trakya University Faculty of Medicine Hospital
Edirne , , Turkey
Gaziantep University Sahinbey Research and Application Center Hospital
Gaziantep , , Turkey
Izmir Ege University Faculty of Medicine Hospital
İzmir , , Turkey
Erciyes University Faculty of Medicine Hospital
Kayseri , 8039, Turkey
Kocaeli University Application
Kocaeli , , Turkey
Mersin University
Mersin , , Turkey
Samsun 19 Mayıs University Health Application Research Hospital
Samsun , , Turkey
Western General Hospital
Edinburgh Scotland, EH4 2, United Kingdom
University Hospital of Wales
Cardiff Wales, CF14 , United Kingdom
Pilgrim Hospital
Boston , PE21 , United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge , CB2 0, United Kingdom
The Clatterbridge Cancer Centre
Liverpool , L7 8Y, United Kingdom
Guy's & St Thomas NHS Foundation Trust
London , SE1 9, United Kingdom
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London , W12 0, United Kingdom
University College London Hospitals
London , , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Department of Haematology, Cancer and Haematology Centre, Churchill Hospital
Oxford , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

430

Study ID:

NCT04603495

Recruitment Status:

Active, not recruiting

Sponsor:


Constellation Pharmaceuticals

How clear is this clinincal trial information?

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