NCT04603495Active, not recruitingPhase 3
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
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
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 430 (actual)
- First submitted
- 20 Oct 2020
- Start date
- 9 Apr 2021
- Primary completion date
- 23 Aug 2023
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT04603495
- EU CT number
- 2023-507954-34-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 430
- From 9 Apr 2021 to the primary completion date, 23 Aug 2023
- 156 sites in 22 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (156)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LKH - Universitätsklinikum Graz; Abteilung für Hämatologie Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Kepler University Hospital Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Krankenhaus der Elisabethinen Linz Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| University Hospital Salzburg Coordinator of this site? Confirm its status | Salzburg | Austria | Unknown status |
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Icon Cancer Centre Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic Coordinator of this site? Confirm its status | Buderim | Australia | Unknown status |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Peninsula Private Hospital Clinical Trials Unit Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| One Clinical Research Pty Ltd Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| ZNA Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Hôpital de Jolimont Coordinator of this site? Confirm its status | La Louvière | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Domaine Universitaire du Sart Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Tom Baker Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| London Health Sciences Center - Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Princess Margaret Cancer Center Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Hämatologisch-Onkologische Praxis Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Unknown status |
| Universitätsklinikum Halle (Saale), Krukenberg-Krebszentrum Halle (KKH) Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| University hospital Hamburg Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Universitätsklinikum Jena, Klinik für Innere Medizin II Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| Universitätsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| ICO Badalona - Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Vall d'Hebron Institute of Oncology Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital San Pedro De Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Unknown status |
| Hospital Universitario de Gran Canaria Dr Negrín Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Quirónsalud Madrid University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Morales Meseguer General University Hospital Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Universitario de Salamanc Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hospital Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| University Hospital of Toledo Coordinator of this site? Confirm its status | Toledo | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Amiens South Hospital univerisy - Hopital Sud Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Centre Hospitalier Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| Hôpital l'Archet 1 Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Gard Cancer Institute Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Centre Hospitalier Lyon Sud Secteur 1G Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Chu Pontchaillou - Service Hematologie Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Institut de Cancérologie Lucien Neuwirth Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| Hopital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Chru Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Pilgrim Hospital Coordinator of this site? Confirm its status | Boston | United Kingdom | Unknown status |
| Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| University Hospital of Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| The Clatterbridge Cancer Centre Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| University College London Hospitals Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's & St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Imperial College Healthcare Nhs Trust - Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Oxford University Hospitals NHS Foundation Trust, Department of Haematology, Cancer and Haematology Centre, Churchill Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Laiko General Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| UGH of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Unknown status |
| University General Hospital of Patras Coordinator of this site? Confirm its status | Rio | Greece | Unknown status |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Unknown status |
| : Pecs University, 1st Department of Medicine Coordinator of this site? Confirm its status | Pécs | Hungary | Unknown status |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Shamir Medical Center Coordinator of this site? Confirm its status | Be’er Ya‘aqov | Israel | Unknown status |
| Lady Davis Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Health Corporation Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Wolfson Medical Center Coordinator of this site? Confirm its status | Holon | Israel | Unknown status |
| Hadassah University Hospital - Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Shaarei Zedek Coordinator of this site? Confirm its status | Nahariya | Israel | Unknown status |
| Rabin Medical Center-Beilinson Campus Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| A.O.U. Policlinico S.Orsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Regional Hospital Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Arcispedale Sant'Anna Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino Amadori Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliera San Gerardo di Monza Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| University Hospital Maggiore della Carita Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| AOU S. Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| University Hospital of Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| University Hospital 'Paolo Giaccone' Polyclinic Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Ospedale Sant'Eugenio Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Hospital Ordine Mauriziano of Turin Coordinator of this site? Confirm its status | Turin | Italy | Unknown status |
| Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi Coordinator of this site? Confirm its status | Varese | Italy | Unknown status |
| Inje University Busan Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Daegu Catholic University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| The Catholic University Of Korea St. Vincent Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| jeonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Jinju | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of South Korea Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Hospital Sultanah Bahiyah Coordinator of this site? Confirm its status | Alor Star | Malaysia | Unknown status |
| Hospital Ampang Coordinator of this site? Confirm its status | Ampang | Malaysia | Unknown status |
| Hospital Pulau Pinang Coordinator of this site? Confirm its status | George Town | Malaysia | Unknown status |
| Hospital Sultanah Aminah Coordinator of this site? Confirm its status | Johor Bahru | Malaysia | Unknown status |
| Hospital Queen Elizabeth Coordinator of this site? Confirm its status | Kota Kinabalu | Malaysia | Unknown status |
| Sunway Medical Centre Coordinator of this site? Confirm its status | Petaling Jaya | Malaysia | Unknown status |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej Coordinator of this site? Confirm its status | Biała Podlaska | Poland | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Pratia Onkologia Katowice Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Centrum Medyczne Pratia Coordinator of this site? Confirm its status | Skorzewo | Poland | Unknown status |
| Nasz Lekarz Przychodnie Medyczne Coordinator of this site? Confirm its status | Torun | Poland | Unknown status |
| King Chulalongkorn Memorial Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Chulabhorn Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Rajavithi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Srinagarind Hospital, Khon Kaen University Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| Songklanagarind Hospital Coordinator of this site? Confirm its status | Songkhla | Thailand | Unknown status |
| Chang-Gung Memorial Hospital - Chiayi Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| University of Michigan Medical Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Cleveland Clinic Taussig Cancer Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Franciscan Health/Indiana blood and Marrow Transplantation Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| UC San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| UCLA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Norton Cancer Institute, St. Matthews Campus Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Weill Cornell Medical College-New York Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Texas Health Science Center San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Dr. Abdurrahman Yurtaslan Oncology Health Application and Research Center Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara University Faculty of Medicine Cebeci Research and Application Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Antalya Medstar Hospital Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
| Edirne Trakya University Faculty of Medicine Hospital Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| Gaziantep University Sahinbey Research and Application Center Hospital Coordinator of this site? Confirm its status | Gaziantep | Turkey (Türkiye) | Unknown status |
| Izmir Ege University Faculty of Medicine Hospital Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Erciyes University Faculty of Medicine Hospital Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
| Kocaeli University Application Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
| Mersin University Coordinator of this site? Confirm its status | Mersin | Turkey (Türkiye) | Unknown status |
| Samsun 19 Mayıs University Health Application Research Hospital Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.