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
- Amsterdam and Utrecht, NetherlandsSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with myelofibrosis (primary, or after polycythemia vera or essential thrombocythemia) who have never taken a JAK inhibitor.
- Age
- 18 Years or older
- Sex
- All sexes
- Disease stage
- Primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. DIPSS risk intermediate-1, intermediate-2 or high. Spleen volume ≥ 450 cm3. Average TSS of ≥15 in the 7 days before randomization. ECOG performance status 0, 1 or 2. Blasts <5% in peripheral blood. Platelet count ≥ 100 x 10^9/L.
- Earlier treatment
- No prior JAK inhibitor or BET inhibitor. No other approved or investigational myelofibrosis treatment, apart from hydroxyurea or anagrelide, within 14 days of the first dose or within 5 half-lives, whichever is longer.
Main reasons for not taking part
- Prior splenectomy, or spleen irradiation in the last 6 months
- Prior hematopoietic cell transplant, or one expected within 24 weeks of randomization
- Blasts ≥ 5% in bone marrow, or history of accelerated phase or leukemic transformation
- Another cancer in the past 3 years that needed systemic treatment
- Prior treatment with any JAK inhibitor or BET inhibitor
Read by machine on 12 November 2026.
Where in Netherlands
- Amsterdam UMC StichtingAmsterdam, NetherlandsNot yet recruiting
- Universitair Medisch Centrum UtrechtUtrecht, NetherlandsNot yet recruiting
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.