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A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.
Official title: A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
460
Start Date
2026-05-27
Completion Date
2030-12-27
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Pelabresib
Pelabresib monohydrate tablets
Ruxolitinib
Ruxolitinib phosphate tablets
Placebo
Matches pelabresib
Locations (125)
Yale University School Of Medicine
New Haven, Connecticut, United States
Florida Cancer Specialist South Reg
Fort Myers, Florida, United States
The Anderson Family Cancer Institute
Jupiter, Florida, United States
Miami NS Ins Baptist Health S FL
Miami, Florida, United States
Florida Cancer Specialists-North
St. Petersburg, Florida, United States
Florida Cancer Specialists East
Stuart, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
American Oncology Partners PA Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Summit Medical Group Oncology
Berkeley Heights, New Jersey, United States
New York Oncology Hematology P C
Albany, New York, United States
Columbia University Medical Center New York Presbyterian
New York, New York, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
TxO Austin Midtown
Austin, Texas, United States
Texas Oncology PA Dallas Presbyterian Hospital
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
SCRI Texas Oncology Northeast Texas
Tyler, Texas, United States
Fred Hutch Cancer Research
Seattle, Washington, United States
Novartis Investigative Site
Buenos Aires, Buenos Aires F.D., Argentina
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CABA, Argentina
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Capital Federal, Argentina
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Córdoba, Argentina
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Adelaide, South Australia, Australia
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Clayton, Victoria, Australia
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Graz, Austria
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Sankt Pölten, Austria
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Goiânia, Goiás, Brazil
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Florianópolis, Santa Catarina, Brazil
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Barretos, São Paulo, Brazil
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Montreal, Quebec, Canada
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Hefei, Anhui, China
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Wuhan, Hubei, China
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Wuhan, Hubei, China
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Nanjing, Jiangsu, China
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Nantong, Jiangsu, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Jinan, Shandong, China
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Yantai, Shandong, China
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Kunming, Yunnan, China
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Hangzhou, Zhejiang, China
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Wenzhou, Zhejiang, China
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Beijing, China
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Chongqing, China
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Fuzhou, China
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Shanghai, China
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Shenyang, China
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Tianjin, China
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Ostrava, Poruba, Czechia
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Brno, Czechia
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Hradec Králové, Czechia
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Olomouc, Czechia
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Brest, France
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Lens, France
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Nîmes, France
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Pessac, France
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Poitiers, France
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Mannheim, Baden-Wurttemberg, Germany
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Aachen, Germany
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Erlangen, Germany
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Aurangabad, Maharashtra, India
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Pune, Maharashtra, India
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Rishikesh, Uttarakhand, India
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Kolkata, West Bengal, India
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Delhi, India
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Meldola, FC, Italy
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Florence, FI, Italy
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Padova, PD, Italy
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Roma, RM, Italy
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Verona, VR, Italy
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Novara, Italy
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Kamogawa, Chiba, Japan
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Sapporo, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Shiwa-Gun, Iwate, Japan
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Tsu, Mie-ken, Japan
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Bunkyo Ku, Tokyo, Japan
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Bunkyo-ku, Tokyo, Japan
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Chūō, Yamanashi, Japan
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Fukuoka, Japan
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Miyazaki, Japan
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George Town, Pulau Pinang, Malaysia
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Kota Kinabalu, Sabah, Malaysia
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Kuching, Sarawak, Malaysia
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Johor Bahru, Malaysia
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Kuala Selangor, Malaysia
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Amsterdam, North Holland, Netherlands
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Utrecht, Netherlands
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Katowice, Poland
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Lublin, Poland
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Skorzewo, Poland
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Torun, Poland
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Warsaw, Poland
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Wałbrzych, Poland
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Suwon, Gyeonggi-do, South Korea
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Jeonju, Jeollabuk-do, South Korea
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Seoul, Yangcheon Gu, South Korea
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Busan, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Las Palmas GC, Spain
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Madrid, Spain
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Basel, Switzerland
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Bern, Switzerland
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Geneva, Switzerland
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Genolier, Switzerland
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Sakarya, Adapazari, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Ankara, Kecioren, Turkey (Türkiye)
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Istanbul, Pendik, Turkey (Türkiye)
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Ankara, Sihhiye Altindag, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)