A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Novartis Pharmaceuticals · NCT07357727
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 460
- US sites recruiting
- 20
- Study start
- May 27, 2026
- Record last updated
- October 26, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Pelabresib; Ruxolitinib; Placebo
Conditions: Primary Myelofibrosis (PMF); Post-polycythemia Vera Myelofibrosis (PPV-MF); Post-essential Thrombocythemia Myelofibrosis (PET-MF)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Rocky Mountain Cancer Centers
Denver, CO 80218
Site contact: Kelly Beland · 303-418-7600 · Kelly.beland@usoncology.com
Yale University School Of Medicine
New Haven, CT 06520
Site contact: Farah Fasihuddin · farah.fasihuddin@yale.edu
Florida Cancer Specialist South Reg
Fort Myers, FL 33916
Site contact: Christina Caruso · Ccaruso@flcancer.com
The Anderson Family Cancer Institute
Jupiter, FL 33458
Site contact: Christine Leonard · christine.leonard@jupitermed.com
Miami NS Ins Baptist Health S FL
Miami, FL 33176
Site contact: Dixie Carmona Gonzalez · 786-596-2000 · Dixie.CarmonaGonzalez@baptisthealth.net
Florida Cancer Specialists-North
St. Petersburg, FL 33705
Site contact: Kelly Whitehead · kelly.whitehead@flcancer.com
Florida Cancer Specialists East
Stuart, FL 34994
Site contact: Mary Jo Luser · MaryJo.Luser@flcancer.com
Winship Cancer Institute of Emory University
Atlanta, GA 30322
Site contact: Danielle Alexander · danielle.oliver@emory.edu
University of Chicago Hospital
Chicago, IL 60637
Site contact: Ellen Malone · ellen.malone@northwestern.edu
Franciscan Health Indianapolis
Indianapolis, IN 42637
Site contact: Melanie Coleman · melanie.coleman@franciscanalliance.org
American Oncology Partners PA Center for Cancer and Blood Disorders
Bethesda, MD 20817
Site contact: Raissa Toure · raissa.toure@aoncology.com
Summit Medical Group Oncology
Berkeley Heights, NJ 07922
Site contact: Michelle Mackenzie · 973-436-1755 · mmackenzie@summithealth.com
New York Oncology Hematology P C
Albany, NY 12206
Site contact: Yolenny Vargas · yolenny.vargas@nyoh.com
Columbia University Medical Center New York Presbyterian
New York, NY 10032
Site contact: Nicole Conwell · 212-305-6953 · nc3272@cumc.columbia.edu
The Ohio State University Comprehensive Cancer Center
Columbus, OH 43221
Site contact: Hannah Davis · Hannah.Davis@osumc.edu
Texas Oncology - Central South
Austin, TX 78705
Site contact: Marian Heaven · marian.heaven@usoncology.com
Texas Oncology PA Dallas Presbyterian Hospital
Dallas, TX 75231
Site contact: Jessica Maner · 214-265-2080 · Jessica.Maner@usoncology.com
MD Anderson Cancer Center
Houston, TX 77030
Site contact: Maria Pinsoy · mbpinsoy@mdanderson.org
SCRI Texas Oncology Northeast Texas
Tyler, TX 75702
Site contact: Shelly Maxfield · shelly.maxfield@usoncology.com
Fred Hutch Cancer Research
Seattle, WA 98109
Site contact: Lisa Grimm · lgrimm@fredhutch.org
Study contacts (from the official record)
- Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
- Novartis Pharmaceuticals · +41613241111 · novartis.email@novartis.com