At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of MF or post-ET or post-PV MF per 2016 WHO classification
- ✓Measurable splenomegaly with spleen volume ≥450 cm³ by MRI or CT
- ✓DIPSS intermediate-1 with symptoms, or intermediate-2, or high-risk
- ✓ECOG Performance Status ≤2
- ✕>10% blasts in peripheral blood or bone marrow (accelerated/blast phase)
- ✕Prior treatment with JAK inhibitors for MF
- ✕Prior treatment with selinexor or other XPO1 inhibitors
- ✕Pregnant or lactating females
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
In Brief
A Phase 2 clinical trial evaluating Selinexor 60 mg, Selinexor 40 mg, and 3 other interventions for Myelofibrosis and 2 related conditions. Currently recruiting, targeting 58 participants across 70 sites in 19 countries.
Signals
Detailed Summary
The main purpose of this study is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and with normal platelet counts or with mild to moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.
Study Details
Timeline
Interventions
Participants will receive selinexor 60 mg oral tablets QW.
Participants will receive selinexor 40 mg oral tablets QW.
Participants will receive ruxolitinib per local package insert.
Participants will receive pacritinib per local package insert. For countries where not approved, 200 mg twice daily is the starting dose.
Participants will receive momelotinib per local package insert.