NCT07357727From ClinicalTrials.govRecruiting

A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)

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

Primary Myelofibrosis (PMF)
Post-polycythemia Vera Myelofibrosis (PPV-MF)
Post-essential Thrombocythemia Myelofibrosis (PET-MF)

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Novartis Pharmaceuticals
Enrolment target: 460
Started: 27 May 2026
Main results due: 17 May 2028
Study sites: 103
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(103)

Yale University School Of Medicine
New Haven, Connecticut, United States
Recruiting
Florida Cancer Specialist South Reg
Fort Myers, Florida, United States
Recruiting
The Anderson Family Cancer Institute
Jupiter, Florida, United States
Recruiting
Miami NS Ins Baptist Health S FL
Miami, Florida, United States
Recruiting
Florida Cancer Specialists-North
St. Petersburg, Florida, United States
Recruiting
Florida Cancer Specialists East
Stuart, Florida, United States
Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Recruiting
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Recruiting
Summit Medical Group Oncology
Berkeley Heights, New Jersey, United States
Recruiting
New York Oncology Hematology P C
Albany, New York, United States
Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Recruiting
Texas Oncology PA Dallas Presbyterian Hospital
Dallas, Texas, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
SCRI Texas Oncology Northeast Texas
Tyler, Texas, United States
Recruiting
Fred Hutch Cancer Research
Seattle, Washington, United States
Recruiting
Novartis Investigative Site
Buenos Aires, Buenos Aires F.D., Argentina
Recruiting
Novartis Investigative Site
CABA, Argentina
Recruiting
Novartis Investigative Site
Capital Federal, Argentina
Recruiting
Novartis Investigative Site
Córdoba, Argentina
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Novartis Investigative Site
Adelaide, South Australia, Australia
Recruiting
Novartis Investigative Site
Clayton, Victoria, Australia
Recruiting
Novartis Investigative Site
Sankt Pölten, Austria
Recruiting
Novartis Investigative Site
Goiânia, Goiás, Brazil
Recruiting
Novartis Investigative Site
Florianópolis, Santa Catarina, Brazil
Recruiting
Novartis Investigative Site
Barretos, São Paulo, Brazil
Recruiting
Novartis Investigative Site
Hefei, Anhui, China
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Novartis Investigative Site
Guangzhou, Guangdong, China
Recruiting
Novartis Investigative Site
Guangzhou, Guangdong, China
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Novartis Investigative Site
Wuhan, Hubei, China
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Novartis Investigative Site
Wuhan, Hubei, China
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Novartis Investigative Site
Nanjing, Jiangsu, China
Recruiting
Novartis Investigative Site
Nantong, Jiangsu, China
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Novartis Investigative Site
Nanchang, Jiangxi, China
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Novartis Investigative Site
Changchun, Jilin, China
Recruiting
Novartis Investigative Site
Jinan, Shandong, China
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Novartis Investigative Site
Yantai, Shandong, China
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Novartis Investigative Site
Kunming, Yunnan, China
Recruiting
Novartis Investigative Site
Hangzhou, Zhejiang, China
Recruiting
Novartis Investigative Site
Wenzhou, Zhejiang, China
Recruiting
Novartis Investigative Site
Beijing, China
Recruiting
Novartis Investigative Site
Chongqing, China
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Novartis Investigative Site
Fuzhou, China
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Novartis Investigative Site
Shanghai, China
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Novartis Investigative Site
Shenyang, China
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Novartis Investigative Site
Tianjin, China
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Novartis Investigative Site
Ostrava, Poruba, Czechia
Recruiting
Novartis Investigative Site
Brno, Czechia
Recruiting
Novartis Investigative Site
Hradec Králové, Czechia
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Olomouc, Czechia
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Novartis Investigative Site
Brest, France
Recruiting
Novartis Investigative Site
Poitiers, France
Recruiting
Novartis Investigative Site
Aurangabad, Maharashtra, India
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Novartis Investigative Site
Pune, Maharashtra, India
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Novartis Investigative Site
Rishikesh, Uttarakhand, India
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Novartis Investigative Site
Kolkata, West Bengal, India
Recruiting
Novartis Investigative Site
Delhi, India
Recruiting
Novartis Investigative Site
Florence, FI, Italy
Recruiting
Novartis Investigative Site
Padova, PD, Italy
Recruiting
Novartis Investigative Site
Roma, RM, Italy
Recruiting
Novartis Investigative Site
Verona, VR, Italy
Recruiting

Showing 60 of 103 sites — filter to narrow it down. 103 of the 103 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07357727. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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