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Taking people in CzechiaPhase 2

Tests selinexor in people with myelofibrosis and low platelet counts

Tests selinexor in adults with myelofibrosis who have not had JAK inhibitor treatment.

Key facts

Who runs it
Karyopharm Therapeutics Inc
Where
Olomouc, CzechiaSee the siteAlso in 18 other countries, 69 sites
Trial code
Registry title
A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Status
Recruiting
Phase
Phase 2
People taking part
58 people, planned
Started
22 Apr 2024
Expected to end
Oct 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Selinexor 60 mg
  • Selinexor 40 mg
  • Ruxolitinib
  • Pacritinib
  • Momelotinib
Record updated
12 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with myelofibrosis who have an enlarged spleen and symptoms, have not been treated with a JAK inhibitor, and have a normal or mildly to moderately low platelet count.

Age
18 years or older
Sex
Women and men can join
Disease stage
Myelofibrosis (including after essential thrombocythemia or polycythemia vera). Spleen volume of 450 cm (14 ft 9 in)^3 or more on MRI or CT. DIPSS risk of intermediate-1 with symptoms, intermediate-2, or high-risk. At least 2 active symptoms at screening.
Earlier treatment
No earlier JAK inhibitor treatment for myelofibrosis. No earlier selinexor or other XPO1 inhibitors. Not currently able to have a stem cell transplant.
Biomarker or test result
Platelet count of 50 x 10^9/L or more. Neutrophil count of 1.0 x 10^9/L or more. Bone marrow biopsy samples are needed.

Main reasons for not taking part

  • More than 10% blasts in blood or bone marrow
  • Pregnant or breastfeeding
  • Spleen removal, spleen radiation or spleen embolization within the last 6 months
  • Heart attack, stroke or heart failure class > 2 within the last 6 months
  • Cannot take two kinds of anti-nausea medicine before each dose

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Previous treatment with JAK inhibitors for MF
  • Previous treatment with selinexor or other XPO1 inhibitors
  • Prior splenectomy, splenic radiation, or a splenic embolization within 6 months prior to C1D1
  • Unable to tolerate two forms of antiemetics prior to each dose for the first two cycles
  • 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
  • More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)
  • Females who are pregnant or lactating

Where in Czechia

Also in 18 other countries, 69 sites

  • Fakultni nemocnice OlomoucOlomouc, CzechiaContact: Antonín HlušíTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Selinexor 60 mg (Arm 1)Treatment being tested

    Participants will receive selinexor 60 milligrams (mg) oral tablets once weekly (QW) (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment. Optional add-on medication dosing may be initiated based on Spleen Volume Reduction (SVR) values at Week 12 or Week 24 of treatment.

    Treatment: Selinexor 60 mg, Ruxolitinib, Pacritinib, and Momelotinib

  • Selinexor 40 mg (Arm 2)Treatment being tested

    Participants will receive selinexor 40 mg oral tablets QW (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment. Optional add-on medication dosing may be initiated based on Spleen Volume Reduction (SVR) values at Week 12 or Week 24 of treatment.

    Treatment: Selinexor 40 mg, Ruxolitinib, Pacritinib, and Momelotinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Plain-language title
Tests selinexor in people with myelofibrosis and low platelet countsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 February 2026