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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT07357727

Registry updated: 2026-10-22
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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.

Interventions

  • Pelabresib (Drug)
    Pelabresib monohydrate tablets
  • Ruxolitinib (Drug)
    Ruxolitinib phosphate tablets
  • Placebo (Drug)
    Matches pelabresib

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.

Conditions

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

Locations

  • Rocky Mountain Cancer Centers — Denver, Colorado, United States
  • Yale University School Of Medicine — New Haven, Connecticut, United States
  • Florida Cancer Specialist South Reg — Fort Myers, Florida, United States
  • The Anderson Family Cancer Institute — Jupiter, Florida, United States
  • Miami NS Ins Baptist Health S FL — Miami, Florida, United States
  • Florida Cancer Specialists-North — St. Petersburg, Florida, United States
  • Florida Cancer Specialists East — Stuart, Florida, United States
  • Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
  • University of Chicago Hospital — Chicago, Illinois, United States
  • Franciscan Health Indianapolis — Indianapolis, Indiana, United States
  • American Oncology Partners PA Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
  • Summit Medical Group Oncology — Berkeley Heights, New Jersey, United States
  • New York Oncology Hematology P C — Albany, New York, United States
  • Columbia University Medical Center New York Presbyterian — New York, New York, United States
  • The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
  • Texas Oncology - Central South — Austin, Texas, United States
  • Texas Oncology PA Dallas Presbyterian Hospital — Dallas, Texas, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • SCRI Texas Oncology Northeast Texas — Tyler, Texas, United States
  • Fred Hutch Cancer Research — Seattle, Washington, United States
  • Hospital de Clinicas Jose de San Martin — Buenos Aires, Buenos Aires F.D., Argentina
  • Hospital Italiano de Buenos Aires — CABA, Argentina
  • FUNDALEU — Capital Federal, Argentina
  • Hospital Privado de Cordoba — Córdoba, Argentina
  • Novartis Investigative Site — Adelaide, South Australia, Australia
  • Novartis Investigative Site — Clayton, Victoria, Australia
  • Novartis Investigative Site — Graz, Austria
  • Novartis Investigative Site — Sankt Pölten, Austria
  • Novartis Investigative Site — Vienna, Austria
  • Novartis Investigative Site — Woluwe-Saint-Lambert, Brussels Capital, Belgium
  • Novartis Investigative Site — Goiânia, Goiás, Brazil
  • Grupo ELORA — Florianópolis, Santa Catarina, Brazil
  • Novartis Investigative Site — Barretos, São Paulo, Brazil
  • Jewish General Hospital — Montreal, Quebec, Canada
  • Novartis Investigative Site — Hefei, Anhui, China
  • Novartis Investigative Site — Guangzhou, Guangdong, China
  • Novartis Investigative Site — Guangzhou, Guangdong, China
  • Novartis Investigative Site — Wuhan, Hubei, China
  • Novartis Investigative Site — Wuhan, Hubei, China
  • Novartis Investigative Site — Nanjing, Jiangsu, China
  • Novartis Investigative Site — Nantong, Jiangsu, China
  • Novartis Investigative Site — Nanchang, Jiangxi, China
  • Novartis Investigative Site — Changchun, Jilin, China
  • Novartis Investigative Site — Jinan, Shandong, China
  • Novartis Investigative Site — Yantai, Shandong, China
  • Novartis Investigative Site — Kunming, Yunnan, China
  • Novartis Investigative Site — Hangzhou, Zhejiang, China
  • Novartis Investigative Site — Wenzhou, Zhejiang, China
  • Novartis Investigative Site — Beijing, China
  • Novartis Investigative Site — Chongqing, China
  • Novartis Investigative Site — Fuzhou, China
  • Novartis Investigative Site — Shanghai, China
  • Novartis Investigative Site — Shenyang, China
  • Novartis Investigative Site — Tianjin, China
  • Novartis Investigative Site — Ostrava, Poruba, Czechia
  • Novartis Investigative Site — Brno, Czechia
  • Novartis Investigative Site — Hradec Králové, Czechia
  • Novartis Investigative Site — Olomouc, Czechia
  • Novartis Investigative Site — Brest, France
  • Novartis Investigative Site — Le Kremlin-Bicêtre, France
  • Novartis Investigative Site — Lens, France
  • Novartis Investigative Site — Nîmes, France
  • Novartis Investigative Site — Paris, France
  • Novartis Investigative Site — Pessac, France
  • Novartis Investigative Site — Poitiers, France
  • Novartis Investigative Site — Rennes, France
  • Novartis Investigative Site — Toulouse, France
  • Novartis Investigative Site — Mannheim, Baden-Wurttemberg, Germany
  • Novartis Investigative Site — Aachen, Germany
  • Novartis Investigative Site — Cottbus, Germany
  • Novartis Investigative Site — Erlangen, Germany
  • Novartis Investigative Site — Hamburg, Germany
  • Novartis Investigative Site — Aurangabad, Maharashtra, India
  • Novartis Investigative Site — Pune, Maharashtra, India
  • Novartis Investigative Site — Rishikesh, Uttarakhand, India
  • Novartis Investigative Site — Kolkata, West Bengal, India
  • Novartis Investigative Site — Delhi, India
  • Novartis Investigative Site — Meldola, FC, Italy
  • Novartis Investigative Site — Florence, FI, Italy
  • Novartis Investigative Site — Monza, MB, Italy
  • Novartis Investigative Site — Padova, PD, Italy
  • Novartis Investigative Site — Roma, RM, Italy
  • Novartis Investigative Site — Verona, VR, Italy
  • Novartis Investigative Site — Novara, Italy
  • Novartis Investigative Site — Kamogawa, Chiba, Japan
  • Novartis Investigative Site — Sapporo, Hokkaido, Japan
  • Novartis Investigative Site — Kobe, Hyōgo, Japan
  • Novartis Investigative Site — Shiwa-Gun, Iwate, Japan
  • Novartis Investigative Site — Tsu, Mie-ken, Japan
  • Novartis Investigative Site — Kurashiki, Okayama-ken, Japan
  • Novartis Investigative Site — Bunkyo Ku, Tokyo, Japan
  • Novartis Investigative Site — Bunkyo-ku, Tokyo, Japan
  • Novartis Investigative Site — Chūō, Yamanashi, Japan
  • Novartis Investigative Site — Fukuoka, Japan
  • Novartis Investigative Site — Kumamoto, Japan
  • Novartis Investigative Site — Miyazaki, Japan
  • Novartis Investigative Site — George Town, Pulau Pinang, Malaysia
  • Novartis Investigative Site — Kota Kinabalu, Sabah, Malaysia
  • Novartis Investigative Site — Kuching, Sarawak, Malaysia
  • Novartis Investigative Site — Johor Bahru, Malaysia
  • Novartis Investigative Site — Kuala Selangor, Malaysia
  • Novartis Investigative Site — Amsterdam, North Holland, Netherlands
  • Novartis Investigative Site — Utrecht, Netherlands
  • Novartis Investigative Site — Katowice, Poland
  • Novartis Investigative Site — Lublin, Poland
  • Novartis Investigative Site — Skorzewo, Poland
  • Novartis Investigative Site — Torun, Poland
  • Novartis Investigative Site — Warsaw, Poland
  • Novartis Investigative Site — Wałbrzych, Poland
  • Novartis Investigative Site — Suwon, Gyeonggi-do, South Korea
  • Novartis Investigative Site — Jeonju, Jeollabuk-do, South Korea
  • Novartis Investigative Site — Seoul, Yangcheon Gu, South Korea
  • Novartis Investigative Site — Busan, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Donostia / San Sebastian, Gipuzkoa, Spain
  • Novartis Investigative Site — El Palmar, Murcia, Spain
  • Novartis Investigative Site — Barcelona, Spain
  • Novartis Investigative Site — Las Palmas GC, Spain
  • Novartis Investigative Site — Madrid, Spain
  • Novartis Investigative Site — Málaga, Spain
  • Novartis Investigative Site — Salamanca, Spain
  • Novartis Investigative Site — Basel, Switzerland
  • Novartis Investigative Site — Bern, Switzerland
  • Novartis Investigative Site — Geneva, Switzerland
  • Novartis Investigative Site — Genolier, Switzerland
  • Novartis Investigative Site — Changhua, Taiwan
  • Novartis Investigative Site — Kaohsiung City, Taiwan
  • Novartis Investigative Site — Tainan, Taiwan
  • Novartis Investigative Site — Taipei, Taiwan
  • Novartis Investigative Site — Sakarya, Adapazari, Turkey (Türkiye)
  • Novartis Investigative Site — Istanbul, Fatih, Turkey (Türkiye)
  • Novartis Investigative Site — Ankara, Kecioren, Turkey (Türkiye)
  • Novartis Investigative Site — Istanbul, Pendik, Turkey (Türkiye)
  • Novartis Investigative Site — Ankara, Sihhiye Altindag, Turkey (Türkiye)
  • Novartis Investigative Site — Ankara, Turkey (Türkiye)
  • Novartis Investigative Site — Izmir, Turkey (Türkiye)
  • Novartis Investigative Site — Kocaeli, Turkey (Türkiye)
  • Novartis Investigative Site — Samsun, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record