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NCT Number: NCT05980806

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Gent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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)

Key Exclusion Criteria:

  • 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

Treatment and study plan

Selinexor 60 mg

Drug

Participants will receive selinexor 60 mg oral tablets QW.

Other names: KPT-330

Selinexor 40 mg

Drug

Participants will receive selinexor 40 mg oral tablets QW.

Other names: KPT-330

Ruxolitinib

Drug

Participants will receive ruxolitinib per local package insert.

Other names: JAKAFI

Pacritinib

Drug

Participants will receive pacritinib per local package insert. For countries where not approved, 200 mg twice daily is the starting dose.

Other names: VONJO

Momelotinib

Drug

Participants will receive momelotinib per local package insert.

Other names: OJJAARA

Primary outcomes

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

    Time frame: At Week 24

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

Secondary outcomes

  1. Absolute Mean Change in Total Symptom Score (Abs-TSS) from baseline to Week 24

    Time frame: At Baseline and Week 24

    Measured by the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.

  2. Incidence and severity of TEAEs, including TRAEs and SAEs

    Time frame: From Baseline to EoS (approximately 48 months)

    Measured by the NCI CTCAE Grading Scale, v. 5, as assessed and graded by the Investigator

Study contacts

Contact information is provided by the study sponsor or research team.

Karyopharm Medical Information

CONTACT

[email protected]

(888) 209-9326

Sponsors and collaborators

Lead sponsor

Karyopharm Therapeutics Inc

Industry

Registry information

Official study title

A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Acronym: SENTRY-2

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 8, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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