Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04603495 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Constellation Pharmaceuticals |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Austria, Belgium, Canada, Czechia, France, Greece, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Poland, Spain, Taiwan, Thailand, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis |
Arms
Experimental: Pelabresib + ruxolitinib
Pelabresib monohydrate tablets + ruxolitinib phosphate tablets
Active Comparator: Placebo + ruxolitinib
Matching placebo tablets + ruxolitinib phosphate tablets
Interventions
Drug: - 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.
Drug: - Ruxolitinib
Ruxolitinib is a JAK inhibitor and a current, approved treatment option for MF.
Drug: - 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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Status
Recruiting
Address
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler, Arizona, 85224
Status
Recruiting
Address
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Status
Recruiting
Address
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Status
Recruiting
Address
UCLA Medical Center
Los Angeles, California, 90095
Status
Recruiting
Address
Yale University School of Medicine
New Haven, Connecticut, 06510
Status
Recruiting
Address
Georgetown University
Washington, District of Columbia, 20007
Status
Recruiting
Address
Mayo Clinic
Jacksonville, Florida, 32224
Status
Recruiting
Address
University of Miami Hospital
Miami, Florida, 33136
Status
Recruiting
Address
Moffitt Cancer Center
Tampa, Florida, 33612
Status
Recruiting
Address
Northwestern
Chicago, Illinois, 60611-5975
Status
Recruiting
Address
University of Chicago Medical Center
Chicago, Illinois, 60637
Status
Recruiting
Address
Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL
Decatur, Illinois, 62526
Status
Recruiting
Address
Loyola University - Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153
Status
Recruiting
Address
Franciscan Health/Indiana blood and Marrow Transplantation
Indianapolis, Indiana, 46237
Status
Recruiting
Address
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207
Status
Recruiting
Address
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Washington University
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Cancer Care Specialists
Reno, Nevada, 89511
Status
Recruiting
Address
Summit Medical Group - Cancer Center
Florham Park, New Jersey, 07932
Status
Recruiting
Address
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Status
Recruiting
Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Status
Recruiting
Address
Weill Cornell Medical College- New York Presbyterian Hospital
New York, New York, 10065
Status
Recruiting
Address
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Status
Recruiting
Address
Oregon Health and Science University
Portland, Oregon, 97239
Status
Recruiting
Address
MD Anderson Cancer Center
Houston, Texas, 77030
Status
Recruiting
Address
Mays Cancer Center at UT Health San Antonio MD Anderson
San Antonio, Texas, 78229
Status
Recruiting
Address
Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute
Seattle, Washington, 98104
International Sites
Status
Recruiting
Address
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076
Status
Recruiting
Address
Icon Cancer Centre
Brisbane, Queensland, 4101
Status
Recruiting
Address
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Status
Recruiting
Address
Monash Health
Clayton, Victoria, 3168
Status
Recruiting
Address
Peninsula Private Hospital Clinical Trials Unit
Frankston, Victoria, 3199
Status
Recruiting
Address
USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic
Buderim, , QLD 4556
Status
Recruiting
Address
One Clinical Research PTY LTD
Nedlands, , 6009
Status
Recruiting
Address
Calvary North Adelaide Hospital
North Adelaide, ,
Status
Recruiting
Address
Calvary North Adelaide Hospital
North Adelaide, ,
Status
Recruiting
Address
LKH - Universitätsklinikum Graz; Abteilung für Hämatologie
Graz, , A-8036
Status
Recruiting
Address
Krankenhaus der Elisabethinen Linz
Linz, , 4020
Status
Recruiting
Address
ZNA
Antwerpen, ,
Status
Recruiting
Address
AZ Sint-Jan
Brugge, ,
Status
Recruiting
Address
Cliniques universitaires Saint-Luc
Brussel, , 1200
Status
Recruiting
Address
UZ Brussel
Jette, , 1090
Status
Recruiting
Address
Hôpital de Jolimont
La Louvière, , 7100
Status
Recruiting
Address
UZ Leuven
Leuven, ,
Status
Recruiting
Address
Domaine Universitaire du Sart Tilman
Liège, , 4000
Status
Recruiting
Address
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Status
Recruiting
Address
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Status
Recruiting
Address
London Health Sciences Center - Victoria Hospital
London, Ontario, N6A 5W9
Status
Recruiting
Address
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Status
Recruiting
Address
Jewish General Hospital
Montréal, Quebec, H3T 1E2
Status
Recruiting
Address
Hôpital Maisonneuve-Rosemont
Montréal, , H1T 2M4
Status
Not yet recruiting
Address
The Ottawa Hospital General Campus
Ottawa, , K1H 8L6
Status
Recruiting
Address
Fakultni nemocnice Hradec Kralove
Hradec Kralove, , 500 05
Status
Recruiting
Address
University Hospital Olomouc
Olomouc, , 779 00
Status
Recruiting
Address
CHU Amiens Picardie
Amiens, , 80054
Status
Not yet recruiting
Address
CHU Henri-Mondor
Créteil, , 94010 Cedex
Status
Recruiting
Address
CHU Henri-Mondor
Créteil, , 94010
Status
Recruiting
Address
Centre Hospitalier
Le Mans, , 72000
Status
Recruiting
Address
Hopital de la Conception
Marseille, , 13385
Status
Recruiting
Address
Hôpital l'Archet 1
Nice, , 06202
Status
Recruiting
Address
CHU DE NIMES _Institut de Cancérologie du Gard
Nîmes, ,
Status
Recruiting
Address
Centre d'Investigations Cliniques
Paris, ,
Status
Recruiting
Address
Centre Hospitalier Lyon Sud Secteur 1G
Pierre-Bénite, , 69310
Status
Recruiting
Address
Chu Pontchaillou - Service Hematologie
Rennes, , 35033
Status
Recruiting
Address
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , 42271
Status
Recruiting
Address
Hôpital Bretonneau
Tours, , 37044
Status
Recruiting
Address
Chru Brabois
Vandœuvre-lès-Nancy, , 54500
Status
Not yet recruiting
Address
University Hospital of Alexandroupolis
Alexandroupolis, ,
Status
Not yet recruiting
Address
General Hospital, School of Medicine National and Kapodistrian University of Athens
Athens, ,
Status
Not yet recruiting
Address
Laiko General Hospital
Athens, ,
Status
Not yet recruiting
Address
Ηippokration General Hospital
Athens, ,
Status
Recruiting
Address
Princess Margaret Hospital
Hong Kong, Kowloon,
Status
Recruiting
Address
Prince of Wales Hospital
Hong Kong, New Territories,
Status
Recruiting
Address
: Pecs University, 1st Department of Medicine
Pécs, Pecs, 7624
Status
Recruiting
Address
Semmelweis University - Internal Medicine and Oncology Clinic
Budapest, , 1088
Status
Recruiting
Address
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia
Debrecen, , 4032
Status
Recruiting
Address
Petz Aladar Egyetemi Oktato Korhaz
Gyor, , 9024
Status
Recruiting
Address
Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia
Nyíregyháza, ,
Status
Not yet recruiting
Address
Wolfson Medical Center
H̱olon, ,
Status
Not yet recruiting
Address
Tel Aviv Sourasky Medical Center
Tel Aviv, , 6423906
Status
Recruiting
Address
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, , 24127
Status
Recruiting
Address
A.O.U. Policlinico S. Orsola-Malpighi
Bologna, , 40138
Status
Recruiting
Address
AOU Policlinico G. Rodolico - San Marco
Catania, ,
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara, ,
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Careggi
Florence, ,
Status
Recruiting
Address
Ospedale Policlinico San Martino IRCCS
Genova, ,
Status
Recruiting
Address
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola, ,
Status
Recruiting
Address
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, ,
Status
Recruiting
Address
Azienda Ospedaliera San Gerardo di Monza
Monza, ,
Status
Recruiting
Address
AOU S.Luigi Gonzaga
Orbassano, ,
Status
Recruiting
Address
Ospedale Sant'Eugenio
Rome, ,
Status
Recruiting
Address
Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi
Varese, ,
Status
Recruiting
Address
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Status
Recruiting
Address
Gyeongsang National University Hospital
Jinju-si, Gyeongsangnam-do,
Status
Recruiting
Address
Inje University Haeundae Paik Hospital
Busan, , 48108
Status
Recruiting
Address
Pusan National University Hospital
Busan, , 49241
Status
Recruiting
Address
Inje University Busan Paik Hospital
Busan, ,
Status
Recruiting
Address
Kyungpook National University Hospital
Daegu, , 41944
Status
Recruiting
Address
Daegu Catholic University Medical Center
Daegu, ,
Status
Recruiting
Address
Keimyung University Dongsan Hospital
Daegu, ,
Status
Recruiting
Address
Cha Bundang Medical Center Cha University
Gyeonggi-do, ,
Status
Recruiting
Address
The Catholic University Of Korea St. Vincent Hospital
Gyeonggi-do, ,
Status
Recruiting
Address
Gachon University Gil Medical Center
Incheon, ,
Status
Recruiting
Address
Jeonbuk National University Hospital
Jeonju, , 54907
Status
Recruiting
Address
Severance Hospital, Yonsei University Health System
Seoul, , 03722
Status
Recruiting
Address
Korea University Guro Hospital
Seoul, , 08307
Status
Recruiting
Address
Samsung Medical Center
Seoul, , 135-710
Status
Recruiting
Address
Hanyang University Medical Center
Seoul, ,
Status
Recruiting
Address
Korea University Anam Hospital
Seoul, ,
Status
Recruiting
Address
Seoul National University Hospital
Seoul, ,
Status
Recruiting
Address
The Catholic University of Korea
Seoul, ,
Status
Recruiting
Address
The Catholic University of South Korea Seoul St. Mary's Hospital
Seoul, ,
Status
Recruiting
Address
Ulsan University Hospital
Ulsan, ,
Status
Recruiting
Address
Amsterdam UMC
Amsterdam, , 1081
Status
Recruiting
Address
Maastricht University Medical Center
Maastricht, , 6229 HX
Status
Recruiting
Address
Wojewódzki Szpital Specjalistyczny w Bialej Podlaskiej
Biała Podlaska, , 21-50
Status
Recruiting
Address
Uniwersyteckie Centrum Kliniczne
Gdańsk, , 80-293
Status
Recruiting
Address
Pratia Onkologia Katowice
Katowice, ,
Status
Recruiting
Address
Centrum Medyczne Pratia
Skorzewo, , 60-185
Status
Recruiting
Address
Nasz Lekarz Przychodnie Medyczne
Toruń, , 87-100
Status
Recruiting
Address
Hospital Universitario Central de Asturias
Oviedo, Asturias, 33011
Status
Recruiting
Address
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, , 8916
Status
Recruiting
Address
Hospital Clinic de Barcelona
Barcelona, ,
Status
Recruiting
Address
Vall d'Hebron Institute of Oncology
Barcelona, ,
Status
Recruiting
Address
Hospital Universitario De Burgos
Burgos, , 09006
Status
Recruiting
Address
Hospital San Pedro de Alcantara
Caceres, , 10003
Status
Recruiting
Address
ICO Girona - Hospital Universitari de Girona
Girona, ,
Status
Recruiting
Address
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, , 35010
Status
Recruiting
Address
Hospital Universitario Fundación Jiménez Díaz
Madrid, , 28040
Status
Recruiting
Address
Complejo Hospitalario de Navarra
Pamplona, , 31008
Status
Recruiting
Address
Hospital Universitario de Salamanc
Salamanca, , 37007
Status
Recruiting
Address
Hospital Virgen Macarena
Sevilla, ,
Status
Recruiting
Address
Hospital Clínico Universitario de Valencia
Valencia, , 46010
Status
Recruiting
Address
Chang Gung Memorial Hospital Chiayi
Chiayi City, ,
Status
Recruiting
Address
China Medical University Hospital
Chiayi City, ,
Status
Recruiting
Address
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, ,
Status
Recruiting
Address
Taichung Veterans General Hospital
Taichung, ,
Status
Recruiting
Address
National Taiwan University Hospital
Taipei, ,
Status
Recruiting
Address
Songklanagarind Hospital
Songkla, Hat Yai District, 90110
Status
Recruiting
Address
Chulabhorn Hospital
Bangkok, Lak Si, 10210
Status
Recruiting
Address
Srinagarind hospital,Khon Kaen University
Khon Kaen, Mueang Khon Kaen District, 40002
Status
Recruiting
Address
King Chulalongkorn Memorial Hospital
Bangkok, Pathumwan, 10330
Status
Recruiting
Address
Rajavithi Hospital
Bangkok, Ratchathewi District, 10400
Status
Not yet recruiting
Address
Western General Hospital
Edinburgh, Scotland, EH4 2XU
Status
Recruiting
Address
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Status
Recruiting
Address
Pilgrim Hospital
Boston, , PE21 9QS
Status
Recruiting
Address
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, , CB2 0QQ
Status
Recruiting
Address
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London, , W12 0HS
Status
Recruiting
Address
University College London Hospitals
London, ,
Status
Recruiting
Address
Oxford University Hospitals NHS Foundation Trust, Department of Haematology, Cancer and Haematology Centre, Churchill Hospital
Oxford, ,