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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
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Pelabresib
Pelabresib monohydrate tablets
Ruxolitinib
Ruxolitinib phosphate tablets
Placebo
Matches pelabresib
Locations (159)
Rocky Mountain Cancer Centers
Denver, Colorado, United States
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
Sanford Research USD Fargo
Fargo, North Dakota, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Texas Oncology - Central South
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
Virginia Cancer Specialists
Fairfax, Virginia, United States
Fred Hutch Cancer Research
Seattle, Washington, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Hospital de Clinicas Jose de San Martin
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Italiano de Buenos Aires
CABA, Argentina
FUNDALEU
Capital Federal, Argentina
Hospital Privado de Cordoba
Córdoba, Argentina
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Sankt Pölten, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Woluwe-Saint-Lambert, Brussels Capital, Belgium
Novartis Investigative Site
Roeselare, Belgium
Novartis Investigative Site
Goiânia, Goiás, Brazil
Novartis Investigative Site
Curitiba, Paraná, Brazil
Grupo ELORA
Florianópolis, Santa Catarina, Brazil
Novartis Investigative Site
Barretos, São Paulo, Brazil
Jewish General Hospital
Montreal, Quebec, Canada
Novartis Investigative Site
Hefei, Anhui, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nantong, Jiangsu, China
Novartis Investigative Site
Nanchang, Jiangxi, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Jinan, Shandong, China
Novartis Investigative Site
Yantai, Shandong, China
Novartis Investigative Site
Kunming, Yunnan, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Wenzhou, Zhejiang, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Chongqing, China
Novartis Investigative Site
Fuzhou, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Shenyang, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Ostrava, Poruba, Czechia
Novartis Investigative Site
Brno, Czechia
Novartis Investigative Site
Hradec Králové, Czechia
Novartis Investigative Site
Olomouc, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Brest, France
Novartis Investigative Site
Le Kremlin-Bicêtre, France
Novartis Investigative Site
Lens, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Nîmes, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Pessac, France
Novartis Investigative Site
Poitiers, France
Novartis Investigative Site
Rennes, France
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, Germany
Novartis Investigative Site
Jena, Thuringia, Germany
Novartis Investigative Site
Aachen, Germany
Novartis Investigative Site
Cottbus, Germany
Novartis Investigative Site
Erlangen, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site
Minden, Germany
Novartis Investigative Site
Chhatrapati Sambhajinagar, Maharashtra, India
Novartis Investigative Site
Pune, Maharashtra, India
Novartis Investigative Site
Rishikesh, Uttarakhand, India
Novartis Investigative Site
Kolkata, West Bengal, India
Novartis Investigative Site
Delhi, India
Novartis Investigative Site
Meldola, FC, Italy
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Monza, MB, Italy
Novartis Investigative Site
Palermo, PA, Italy
Novartis Investigative Site
Padova, PD, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Verona, VR, Italy
Novartis Investigative Site
Naples, Italy
Novartis Investigative Site
Novara, Italy
Novartis Investigative Site
Kamogawa, Chiba, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan