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.
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
Birmingham Alabama, 35294, United States
Chandler Arizona, 85224, United States
La Jolla California, 92093, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
New Haven Connecticut, 06510, United States
Washington District of Columbia, 20007, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Maywood Illinois, 60153, United States
Indianapolis Indiana, 46237, United States
Louisville Kentucky, 40207, United States
Ann Arbor Michigan, 48109, United States
Saint Louis Missouri, 63110, United States
Reno Nevada, 89511, United States
Florham Park New Jersey, 07932, United States
New York New York, 10029, United States
New York New York, 10065, United States
New York New York, 10065, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Seattle Washington, 98104, United States
Wahroonga New South Wales, 2076, Australia
Brisbane Queensland, 4101, Australia
Adelaide South Australia, 5000, Australia
Clayton Victoria, 3168, Australia
Frankston Victoria, 3199, Australia
Buderim , QLD 4, Australia
Nedlands , 6009, Australia
North Adelaide , , Australia
Graz , A-803, Austria
Linz , 4020, Austria
Antwerpen , , Belgium
Brugge , , Belgium
Brussel , 1200, Belgium
Jette , 1090, Belgium
La Louvière , 7100, Belgium
Leuven , , Belgium
Liège , 4000, Belgium
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 2, Canada
London Ontario, N6A 5, Canada
Toronto Ontario, M5G 2, Canada
Montréal Quebec, H3T 1, Canada
Montréal , H1T 2, Canada
Ottawa , K1H 8, Canada
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Amiens , 80054, France
Créteil , 94010, France
Créteil , 94010, France
Le Mans , 72000, France
Marseille , 13385, France
Nice , 06202, France
Nîmes , , France
Paris , , France
Pierre-Bénite , 69310, France
Rennes , 35033, France
Saint-Priest-en-Jarez , 42271, France
Tours , 37044, France
Vandœuvre-lès-Nancy , 54500, France
Ulm Baden-Württemberg, 89081, Germany
Augsburg Bayern, 86151, Germany
Minden Nordrhein-Westfalen, 32429, Germany
Chemnitz Sachsen, 09116, Germany
Halle Sachsen, 06120, Germany
Jena Thüringen, 07747, Germany
Hamburg , 20251, Germany
Alexandroupolis , , Greece
Athens , , Greece
Athens , , Greece
Athens , , Greece
Hong Kong Kowloon, , Hong Kong
Hong Kong New Territories, , Hong Kong
Pécs Pecs, 7624, Hungary
Budapest , 1088, Hungary
Debrecen , 4032, Hungary
Gyor , 9024, Hungary
Nyíregyháza , , Hungary
Ashkelon , 78306, Israel
Be'er Sheva , 84101, Israel
Be'er Ya'aqov , 60930, Israel
Haifa , 31096, Israel
Haifa , 34362, Israel
H̱olon , Itayz, Israel
H̱olon , , Israel
Jerusalem , 91031, Israel
Jerusalem , 95903, Israel
Nahariya , 22100, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52656, Israel
Reẖovot , 76100, Israel
Tel Aviv , 64239, Israel
Bergamo , 24127, Italy
Bologna , 40138, Italy
Catania , , Italy
Ferrara , , Italy
Florence , , Italy
Genova , , Italy
Meldola , , Italy
Milano , , Italy
Monza , , Italy
Orbassano , , Italy
Rome , , Italy
Varese , , Italy
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Jinju-si Gyeongsangnam-do, , Korea, Republic of
Busan , 48108, Korea, Republic of
Busan , 49241, Korea, Republic of
Busan , , Korea, Republic of
Daegu , 41944, Korea, Republic of
Daegu , , Korea, Republic of
Daegu , , Korea, Republic of
Gyeonggi-do , , Korea, Republic of
Gyeonggi-do , , Korea, Republic of
Incheon , , Korea, Republic of
Jeonju , 54907, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 08307, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Ulsan , , Korea, Republic of
Johor Bahru Johor, 80100, Malaysia
Alor Setar Kedah, 05460, Malaysia
George Town Penang, 10450, Malaysia
Ampang Selangor, 68000, Malaysia
Petaling Jaya Selangor, 47500, Malaysia
Kuala Lumpur , 59100, Malaysia
Amsterdam , 1081, Netherlands
Maastricht , 6229 , Netherlands
Biała Podlaska , 21-50, Poland
Gdańsk , 80-29, Poland
Katowice , , Poland
Skorzewo , 60-18, Poland
Toruń , 87-10, Poland
Oviedo Asturias, 33011, Spain
Badalona , 8916, Spain
Barcelona , , Spain
Barcelona , , Spain
Burgos , 09006, Spain
Caceres , 10003, Spain
Girona , , Spain
Las Palmas de Gran Canaria , 35010, Spain
Madrid , 28040, Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Sevilla , , Spain
Valencia , 46010, Spain
Chiayi City , , Taiwan
Chiayi City , , Taiwan
Kaohsiung , , Taiwan
Taichung , , Taiwan
Taipei , , Taiwan
Songkla Hat Yai District, 90110, Thailand
Bangkok Lak Si, 10210, Thailand
Khon Kaen Mueang Khon Kaen District, 40002, Thailand
Bangkok Pathumwan, 10330, Thailand
Bangkok Ratchathewi District, 10400, Thailand
Ankara , , Turkey
Ankara , , Turkey
Antalya , , Turkey
Edirne , , Turkey
Gaziantep , , Turkey
İzmir , , Turkey
Kocaeli , , Turkey
Mersin , , Turkey
Samsun , , Turkey
Edinburgh Scotland, EH4 2, United Kingdom
Cardiff Wales, CF14 , United Kingdom
Boston , PE21 , United Kingdom
Cambridge , CB2 0, United Kingdom
London , W12 0, United Kingdom
London , , United Kingdom
Oxford , , United Kingdom
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