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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
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.
Proportion of Participants with Spleen Volume Reduction ≥35% (SVR35) at Week 24
Measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan by Investigator assessment.
Time frame: At Week 24
Absolute Mean Change in Total Symptom Score (Abs-TSS) from baseline to Week 24
Measured by the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.
Time frame: At Baseline and Week 24
Incidence and severity of TEAEs, including TRAEs and SAEs
Measured by the NCI CTCAE Grading Scale, v. 5, as assessed and graded by the Investigator
Time frame: From Baseline to EoS (approximately 48 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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