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New treatment option for Primary Myelofibrosis (PMF)
Official title Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
ClinicalTrials.gov ID: NCT07340138
What this study is testing
What is Pelabresib?
Pelabresib is an investigational medicine, given as an once-daily 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
- This Phase 1b, multicenter, open-label study aims to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of pelabresib as add-on to ruxolitinib in Japanese patients with myelofibrosis (MF).
- Phase 1: an early, usually small safety study
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), post-polycythemia vera MF (Post-PV MF) or post-essential thrombocythemia MF (Post-ET MF)...
- DIPSS risk category intermediate-1, intermediate-2 or high-risk at screening.
- Participants currently treated with ruxolitinib monotherapy AND who are likely to benefit from the addition of pelabresib to ruxolitinib in the...
- Receiving ruxolitinib at a stable dose (5 to 25 mg BID) for at least 8 weeks prior to the first dose of pelabresib.
- Palpable spleen (spleen length below left costal margin [LCM] must be recorded) or documented splenomegaly by MRI or CT (image report must be...
You likely can't join if
- Prior splenectomy at any time or splenic irradiation in the previous 6 months
- Prior hematopoietic cell transplant or participants anticipated to receive a hematopoietic cell transplant within 24 weeks from the first dose of...
- Blasts ≥ 5% in bone marrow if results available at screening or history of accelerated phase or leukemic transformation.
- History of a malignancy (other than MF, PV or ET) except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical...
- Received any approved or investigational agent for the treatment of MF except ruxolitinib within 14 days of first dose of pelabresib or within 5...
See the full eligibility criteria
- Participants have diagnosis of primary myelofibrosis (PMF), post-polycythemia vera MF (Post-PV MF) or post-essential thrombocythemia MF (Post-ET MF) according to the International Consensus Classification (ICC) for...
- DIPSS risk category intermediate-1, intermediate-2 or high-risk at screening.
- Participants currently treated with ruxolitinib monotherapy AND who are likely to benefit from the addition of pelabresib to ruxolitinib in the opinion of the investigator.
- Receiving ruxolitinib at a stable dose (5 to 25 mg BID) for at least 8 weeks prior to the first dose of pelabresib.
- Palpable spleen (spleen length below left costal margin [LCM] must be recorded) or documented splenomegaly by MRI or CT (image report must be recorded) at screening.
- Platelet count ≥ 100 × 10\^9/L in the absence of growth factor support (including thrombopoietin mimetics/agonists) or platelet transfusions 4 weeks prior to the first dose of pelabresib.
- Blasts \< 5% in peripheral blood. Assessment of blasts in peripheral blood is mandatory at screening. Key
- Prior splenectomy at any time or splenic irradiation in the previous 6 months
- Prior hematopoietic cell transplant or participants anticipated to receive a hematopoietic cell transplant within 24 weeks from the first dose of pelabresib.
- Blasts ≥ 5% in bone marrow if results available at screening or history of accelerated phase or leukemic transformation.
- History of a malignancy (other than MF, PV or ET) except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate...
- Received any approved or investigational agent for the treatment of MF except ruxolitinib within 14 days of first dose of pelabresib or within 5 half-lives of the approved or investigational agent, whichever is longer...
The study team makes the final eligibility decision.
Where it's taking place
- Kamogawa, Chiba, Japan
- Sapporo, Hokkaido, Japan
- Kamakura, Kanagawa, Japan
- Kurashiki, Okayama-ken, Japan
- Bunkyo Ku, Tokyo, Japan
- Chūō, Yamanashi, Japan
- Kumamoto, Japan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Kamogawa, Chiba, Japan; Sapporo, Hokkaido, Japan; Kamakura, Kanagawa, Japan; Kurashiki, Okayama-ken, Japan; Bunkyo Ku, Tokyo, Japan; Chūō, Yamanashi, Japan and 1 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.