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Selinexor for Myelofibrosis with Moderate Thrombocytopenia

This study is testing a drug called selinexor in people with myelofibrosis (MF), a type of bone marrow cancer, who have not yet received JAK inhibitor treatments and have normal to moderately low platelet counts. The main goal is to see how well selinexor reduces spleen size after 24 weeks. Researchers are also looking at other effects and safety of the drug. You might be eligible if you are 18 or older, have been diagnosed with MF, and have an enlarged spleen that can be measured by MRI or CT scan. The study plans to enroll about 58 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 58 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Week 24, indicating follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05980806

A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Recruiting
PHASE2Ages 18+InterventionalTreatment
Karyopharm Therapeutics Inc
~58 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:Selinexor 60 mgSelinexor 40 mgRuxolitinibPacritinibMomelotinib

At a glance

Recruiting sites
70 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants with Spleen Volume Reduction ≥35% (SVR35) at Week 24
Measured over At Week 24

Conditions

Myelofibrosis
Moderate Thrombocytopenia
Mild Thrombocytopenia

Explore related trials

Myelofibrosis

Where it's being run

70 sites across 42 states
Italy8
Bulgaria5
Spain5
France3
Poland3
Romania3
Taiwan3
Belgium2

Who to contact

Karyopharm Medical Information
[email protected]
(888) 209-9326
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

A diagnosis of MF or post-ET or post-PV MF according to the 2016 World Health Organization (WHO) classification of MPN, confirmed by the most recent local pathology report
Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (\>=) 450 cubic square centimeter (cm\^3) by MRI or CT scan (results from MRI or CT imaging performed within 28 days prior to C1D1 are acceptable)
DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk
ECOG Performance Status less than or equal to (\<=) 2
Platelet count of greater than or equal to (\>=) 50 x 10\^9/L without platelet transfusion within 7 days prior to the first dose of selinexor
Absolute neutrophil count (ANC) \>=1.0 × 10\^9/L without need for growth factors within 7 days prior to the first dose of selinexor
Adequate liver function as defined by the following: aspartate transaminase (AST) and alanine transaminase (ALT) \<= 2.5 × upper limit normal (ULN) and serum total bilirubin \<= 3×ULN
Calculated creatinine clearance (CrCl) greater than (\>) 15 milliliter per minute (mL/min) based on the Cockcroft and Gault formula
Active symptoms of MF as determined by presence of at least 2 symptoms with an average score \>= 5 or total score of \>= 12 at screening (at least 5 of 7 consecutive days immediately preceding C1D1) using the MFSAF V4.0
Must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study
Currently not eligible for stem cell transplantation
Must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50)

Exclusion

More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)
Previous treatment with JAK inhibitors for MF
Previous treatment with selinexor or other XPO1 inhibitors
Females who are pregnant or lactating
Prior splenectomy, splenic radiation, or a splenic embolization within 6 months prior to C1D1
History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG), cerebrovascular accident (transient ischemic attack \[TIA\]), ventricular arrhythmias, congestive heart failure class \> 2 per New York Heart Association (NYHA) within 6 months of C1D1
Unable to tolerate two forms of antiemetics prior to each dose for the first two cycles

What this trial measures

  • Proportion of Participants with Spleen Volume Reduction ≥35% (SVR35) at Week 24At Week 24

    Measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan by Investigator assessment.