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Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
Sponsor: Novartis Pharmaceuticals
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.
Official title: A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
430
Start Date
2021-04-09
Completion Date
2027-06-30
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
Pelabresib
Double-blind treatment (pelabresib or matching placebo) will be administered daily for 14 consecutive days followed by a 7-day break, which is considered 1 cycle of treatment (1 cycle = 21 days). Pelabresib is a small molecule inhibitor of BET proteins with a novel mechanism of action and potential for disease-modifying effects in MF.
Ruxolitinib
Ruxolitinib is a JAK inhibitor and a current, approved treatment option for MF.
Placebo
Placebo tablets are designed to match pelabresib tablets. Each placebo tablet contains no active pharmaceutical ingredient and is visibly identical to experimental drug in size, shape, and packaging. Placebo dosing follows the same dosing conventions as pelabresib.
Locations (156)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL
Decatur, Illinois, United States
Franciscan Health/Indiana blood and Marrow Transplantation
Indianapolis, Indiana, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College- New York Presbyterian Hospital
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Science Center - San Antonio
San Antonio, Texas, United States
Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute
Seattle, Washington, United States
Icon Cancer Centre
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Peninsula Private Hospital Clinical Trials Unit
Frankston, Victoria, Australia
USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic
Buderim, Australia
One Clinical Research PTY LTD
Nedlands, Australia
LKH - Universitätsklinikum Graz; Abteilung für Hämatologie
Graz, Austria
Krankenhaus der Elisabethinen Linz
Linz, Austria
Kepler University Hospital
Linz, Austria
University Hospital Salzburg
Salzburg, Austria
ZNA
Antwerp, Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium
Hôpital de Jolimont
La Louvière, Belgium
UZ Leuven
Leuven, Belgium
Domaine Universitaire du Sart Tilman
Liège, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
London Health Sciences Center - Victoria Hospital
London, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
University Hospital Olomouc
Olomouc, Czechia
Amiens South Hospital univerisy - Hopital Sud
Amiens, France
Centre Hospitalier
Le Mans, France
Hôpital l'Archet 1
Nice, France
Gard Cancer Institute
Nîmes, France
Centre Hospitalier Lyon Sud Secteur 1G
Pierre-Bénite, France
Chu Pontchaillou - Service Hematologie
Rennes, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France
Hôpital Bretonneau
Tours, France
Chru Brabois
Vandœuvre-lès-Nancy, France
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Hämatologisch-Onkologische Praxis Augsburg
Augsburg, Bavaria, Germany
Universitätsklinikum Halle (Saale), Krukenberg-Krebszentrum Halle (KKH)
Halle, Saxony, Germany
Universitätsklinikum Jena, Klinik für Innere Medizin II
Jena, Thuringia, Germany
University Hospital Hamburg-Eppendorf
Hamburg, Germany
Laiko General Hospital
Athens, Greece
UGH of Ioannina
Ioannina, Greece
University General Hospital of Patras
Rio, 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, Hungary
Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia
Nyíregyháza, Hungary
Soroka Medical Center
Beersheba, Israel
Shamir Medical Center
Be’er Ya‘aqov, Israel
Rambam Health Corporation
Haifa, Israel
Lady Davis Carmel Medical Center
Haifa, Israel
Wolfson Medical Center
Holon, Israel
Hadassah University Hospital-Ein Kerem
Jerusalem, Israel
Shaarei Zedek
Nahariya, Israel
Rabin Medical Center - Beilinson Campus,
Petah Tikva, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Italy
A.O.U. Policlinico S. Orsola-Malpighi
Bologna, Italy
Regional Hospital Spedali Civili di Brescia
Brescia, 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
Milan, Italy
Azienda Ospedaliera San Gerardo di Monza
Monza, Italy
University Hospital Maggiore della Carità
Novara, Italy
AOU S.Luigi Gonzaga
Orbassano, Italy
University Hospital of Padova
Padova, Italy
University Hospital 'Paolo Giaccone' Polyclinic
Palermo, Italy
Ospedale Sant'Eugenio
Rome, Italy
Hospital Ordine Mauriziano of Turin
Turin, Italy
Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi
Varese, Italy
Hospital Sultanah Aminah
Johor Bahru, Johor, Malaysia
Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
:Hospital Ampang
Ampang, Selangor, Malaysia
Sunway Medical Centre
Petaling Jaya, Selangor, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Malaysia
Amsterdam UMC
Amsterdam, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Wojewódzki Szpital Specjalistyczny w Bialej Podlaskiej
Biała Podlaska, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Pratia Onkologia Katowice
Katowice, Poland
Centrum Medyczne Pratia
Skorzewo, Poland
Nasz Lekarz Przychodnie Medyczne
Torun, Poland
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
The Catholic University Of Korea St. Vincent Hospital
Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea
Seoul, South Korea
The Catholic University of South Korea Seoul St. Mary's Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Vall d'Hebron Institute of Oncology
Barcelona, Spain
Hospital San Pedro de Alcantara
Cáceres, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Spain
Quirónsalud Madrid University Hospital
Madrid, Spain
Morales Meseguer General University Hospital
Murcia, Spain
Hospital Universitario de Salamanc
Salamanca, Spain
Hospital Virgen Macarena
Seville, Spain
University Hospital of Toledo
Toledo, Spain
Hospital Clínico Universitario de Valencia
Valencia, 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
Songkhla, Hat Yai District, Thailand
Chulabhorn Hospital
Bangkok, Lak Si, Thailand
Srinagarind hospital,Khon Kaen University
Khon Kaen, Mueang Khon Kaen District, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Pathumwan, Thailand
Rajavithi Hospital
Bangkok, Ratchathewi District, Thailand
Ankara University Faculty of Medicine Cebeci Research and Application Hospital
Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Health Application and Research Center
Ankara, Turkey (Türkiye)
Antalya Medstar Hospital
Antalya, Turkey (Türkiye)
Edirne Trakya University Faculty of Medicine Hospital
Edirne, Turkey (Türkiye)
Gaziantep University Sahinbey Research and Application Center Hospital
Gaziantep, Turkey (Türkiye)
Izmir Ege University Faculty of Medicine Hospital
Izmir, Turkey (Türkiye)
Erciyes University Faculty of Medicine Hospital
Kayseri, Turkey (Türkiye)
Kocaeli University Application
Kocaeli, Turkey (Türkiye)
Mersin University
Mersin, Turkey (Türkiye)
Samsun 19 Mayıs University Health Application Research Hospital
Samsun, Turkey (Türkiye)
Western General Hospital
Edinburgh, Scotland, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Pilgrim Hospital
Boston, United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
The Clatterbridge Cancer Centre
Liverpool, United Kingdom
Guy's & St Thomas NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London, 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