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

NCT07357727

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

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

Interventions: Pelabresib, Ruxolitinib, Placebo

Countries: United States, Argentina, Australia, China, India, Malaysia, South Korea, Switzerland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (30)
  • Berkeley Heights, New Jersey, United States
  • Columbus, Ohio, United States
  • Buenos Aires, Buenos Aires F.D., Argentina
  • Capital Federal, Argentina
  • Clayton, Victoria, Australia
  • Hefei, Anhui, China
  • Guangzhou, Guangdong, China
  • Nantong, Jiangsu, China
  • Yantai, Shandong, China
  • Wenzhou, Zhejiang, China
  • Beijing, China
  • Chongqing, China
  • Fuzhou, China
  • Shenyang, China
  • Tianjin, China
  • Pune, Maharashtra, India
  • Kolkata, West Bengal, India
  • Johor Bahru, Malaysia
  • Kuala Selangor, Malaysia
  • Suwon, Gyeonggi-do, South Korea
  • Jeonju, Jeollabuk-do, South Korea
  • Seoul, Yangcheon Gu, South Korea
  • Busan, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Basel, Switzerland
  • Geneva, Switzerland
  • Genolier, Switzerland