Actively Recruiting
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Led by Novartis Pharmaceuticals · Updated on 2026-05-11
460
Participants Needed
6
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis according to ICC 2022
- DIPSS risk category of intermediate-1, intermediate-2, or high-risk
- Spleen volume of at least 450 cm3 by CT or MRI scan
- Average total symptom score (TSS) of 15 or higher within 7 days before randomization
- ECOG performance status of 0, 1, or 2
- Less than 5% blasts in peripheral blood at screening
- Platelet count of at least 100 x 10^9/L without growth factors or transfusions in the previous 4 weeks
You will not qualify if you...
- Prior splenectomy at any time or splenic irradiation within the last 6 months
- Prior hematopoietic cell transplant or expected to receive one within 24 weeks of randomization
- 5% or more blasts in bone marrow or history of accelerated phase or leukemic transformation
- History of other malignancies requiring systemic treatment in the past 3 years
- Received any approved or investigational treatment for myelofibrosis other than hydroxyurea or anagrelide within 14 days or 5 half-lives before study treatment
- Prior treatment with any JAK inhibitor or BET inhibitor
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Summit Medical Group
Berkeley Heights, New Jersey, United States, 07922
Actively Recruiting
2
Novartis Investigative Site
Seoul, Yangcheon Gu, South Korea, 07985
Actively Recruiting
3
Novartis Investigative Site
Seoul, South Korea, 03080
Actively Recruiting
4
Novartis Investigative Site
Seoul, South Korea, 05505
Actively Recruiting
5
Novartis Investigative Site
Seoul, South Korea, 06591
Actively Recruiting
6
Novartis Investigative Site
Genolier, Switzerland, 1272
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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