Actively Recruiting
Phase 2 Study of Selinexor Pills for Treating Myelofibrosis in Adults New to JAK Inhibitor Therapy with Mild to Moderate Low Platelet Counts
Led by Karyopharm Therapeutics Inc · Updated on 2026-02-12
58
Participants Needed
70
Research Sites
69 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating selinexor, a drug, in people with myelofibrosis MF who have not previously been treated with JAK inhibitors and who have normal or mildly to moderately low platelet counts. The main goal is to see if selinexor can reduce spleen size by at least 35% after 24 weeks. The study also looks at other measures of effectiveness and safety during the treatment period. Participants receive oral selinexor tablets once weekly, either 60 mg or 40 mg, taken on days 1, 8, 15, and 22 of each 28-day cycle. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. Based on how the spleen responds at weeks 12 or 24, additional medications may be added to the treatment plan. During the study, participants will provide bone marrow biopsy samples and complete daily symptom assessments using a special questionnaire. Researchers will monitor spleen volume, symptom changes, and any side effects from the treatment. The study is planned to last up to about 48 months, allowing for long-term safety and effectiveness evaluation.
CONDITIONS
Brief Title
A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Research Team
K
Karyopharm Medical Information
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