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A PHASE 1/3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SELINEXOR, A SELECTIVE INHIBITOR OF NUCLEAR EXPORT, IN COMBINATION WITH RUXOLITINIB IN TREATMENT-NAÏVE PATIENTS WITH MYELOFIBROSIS
EU CTIS ID: 2023-506139-13-00
What this study is testing
Primary: To evaluate the efficacy of selinexor + ruxolitinib compared to placebo + ruxolitinib in patients with MF.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Spleen volume of ≥450 cm3 by MRI or CT scan.
- DIPSS risk category of intermediate-1, or intermediate-2, or high-risk.
- ECOG Performance Status ≤2.
- Platelet count ≥100 × 109/L without platelet transfusion.
- Active symptoms of MF as determined by presence of at least 2 symptoms with a score ≥3 or total score of ≥10 at screening using the MFSAF V4.0.
You likely can't join if
- Previous treatment with JAK inhibitors for MF.
- More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Democratic People's Republic of
- Israel
- United Kingdom
- Taiwan
- Canada
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Democratic People's Republic of; Israel; United Kingdom; Taiwan; Canada. 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 EU CTIS; the study team decides eligibility.