A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF), Post-essential Thrombocythemia Myelofibrosis (PET-MF)
In brief
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.
Key facts
- Study ID
- NCT07357727
- Run by
- Novartis Pharmaceuticals
- People needed
- 460
- Starts
- 2026-06-16
- Expected to finish
- 2030-12-27
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Summit Medical Group Oncology — Berkeley Heights, New Jersey, United States (enrolling)
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
- Novartis Investigative Site — Buenos Aires, Buenos Aires F.D., Argentina (enrolling)
- Novartis Investigative Site — Capital Federal, Argentina (enrolling)
- Novartis Investigative Site — Clayton, Victoria, Australia (enrolling)
- Novartis Investigative Site — Hefei, Anhui, China (enrolling)
- Novartis Investigative Site — Guangzhou, Guangdong, China (enrolling)
- Novartis Investigative Site — Nantong, Jiangsu, China (enrolling)
- Novartis Investigative Site — Yantai, Shandong, China (enrolling)
- Novartis Investigative Site — Wenzhou, Zhejiang, China (enrolling)
- Novartis Investigative Site — Beijing, China (enrolling)
- Novartis Investigative Site — Chongqing, China (enrolling)
- Novartis Investigative Site — Fuzhou, China (enrolling)
- Novartis Investigative Site — Shenyang, China (enrolling)
- Novartis Investigative Site — Tianjin, China (enrolling)
- Novartis Investigative Site — Pune, Maharashtra, India (enrolling)
- Novartis Investigative Site — Kolkata, West Bengal, India (enrolling)
- Novartis Investigative Site — Johor Bahru, Malaysia (enrolling)
- Novartis Investigative Site — Kuala Selangor, Malaysia (enrolling)
- Novartis Investigative Site — Suwon, Gyeonggi-do, South Korea (enrolling)
- Novartis Investigative Site — Jeonju, Jeollabuk-do, South Korea (enrolling)
- Novartis Investigative Site — Seoul, Yangcheon Gu, South Korea (enrolling)
- Novartis Investigative Site — Busan, South Korea (enrolling)
- Novartis Investigative Site — Seoul, South Korea (enrolling)
- Novartis Investigative Site — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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