NCT07357727 A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
| NCT ID | NCT07357727 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Primary Myelofibrosis (PMF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 460 participants |
| Start Date | 2026-06-16 |
| Primary Completion | 2028-05-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 460 participants in total. It began in 2026-06-16 with a primary completion date of 2028-05-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 * 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 * 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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07357727 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Myelofibrosis (PMF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07357727 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 460 participants.
Is NCT07357727 currently recruiting?
Yes, NCT07357727 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07357727 trial being conducted?
This trial is being conducted at Berkeley Heights, United States, Columbus, United States, Buenos Aires, Argentina, Capital Federal, Argentina and 11 additional locations.
Who is sponsoring the NCT07357727 clinical trial?
NCT07357727 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 460 participants.