Tests pelabresib with ruxolitinib in adults with myelofibrosis
Tests pelabresib plus ruxolitinib in adults with myelofibrosis not yet treated with JAK inhibitors.
Plain-language title generated from the registry record
Registry title: A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 3
Where in Canada
- Jewish General HospitalMontreal, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07357727EU 2025-523555-66-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participants have diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera myelofibrosis (post-PV MF) or post-essential thrombocythemia myelofibrosis (post-ET MF) according to the International Consensus Classification (ICC) of Myeloid Neoplasms and Acute Leukemias 2022; DIPSS risk category of intermediate-1, intermediate-2 or high-risk; Spleen volume ≥ 450 cm3 by CT or MRI scan (local read sufficient if no central read available); Have an average TSS of ≥15 within 7 days prior to randomization, using MFSAF v. 4.0 (at least 4 out of 7 TSS assessments required for average calculation); Participants with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2; Blasts <5% in peripheral blood. Assessment of blasts in peripheral blood is mandatory at screening; Platelet count ≥ 100 x 10\^9/L in the absence of growth factors or transfusions for the previous 4 weeks.
Exclusion: Prior splenectomy at any time or splenic irradiation in the previous 6 months; Prior hematopoietic cell transplant or participant anticipated to receive a hematopoietic cell transplant within 24 weeks from the date of randomization; Received any approved or investigational agent other than hydroxyurea or anagrelide for the treatment of MF within 14 days of first dose of study treatment or within 5 half-lives of the approved or investigational agent, whichever is longer; Prior treatment with any JAK inhibitor or Bromodomain and extraterminal domain (BET) inhibitor; Other protocol-defined inclusion/exclusion criteria may apply; Blasts ≥ 5% in bone marrow if results available at screening or history of accelerated phase (AP) or leukemic transformation; History of a malignancy (other than MF, PPV-MF or PET-MF) in the past 3 years in need of systemic treatment.