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New treatment option for Primary Myelofibrosis (PMF)
Official title A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
ClinicalTrials.gov ID: NCT07357727
What this study is testing
What is Pelabresib?
Pelabresib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for primary myelofibrosis (pmf).
Also referred to as DAK539.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants have diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera myelofibrosis (post-PV MF) or post-essential thrombocythemia...
- 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...
- Participants with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
You likely can't join if
- 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...
- 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...
- Prior treatment with any JAK inhibitor or Bromodomain and extraterminal domain (BET) inhibitor Other protocol-defined inclusion/exclusion criteria...
See the full eligibility 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...
- 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
- 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...
- Prior treatment with any JAK inhibitor or Bromodomain and extraterminal domain (BET) inhibitor Other protocol-defined inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- 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
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.