At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Selinexor 60 mg (drug), Selinexor 40 mg (drug), Ruxolitinib (drug), Pacritinib (drug)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- Selinexor 60 mg — drug: Participants will receive selinexor 60 mg oral tablets QW. · Selinexor 40 mg — drug: Participants will receive selinexor 40 mg oral tablets QW. · Ruxolitinib — drug: Participants will receive ruxolitinib per local package insert. · Pacritinib — drug: Participants will receive pacritinib per local package insert. · Momelotinib — drug: Participants will receive momelotinib per local package insert.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study tests a drug called selinexor on its own in people with myelofibrosis (a rare bone marrow condition) who have not previously taken JAK inhibitor medicines and who have moderately low platelet counts (platelets are blood cells that help clotting). Selinexor works by blocking a protein called XPO1. The sponsor is Karyopharm Therapeutics Inc.
Who can take part
- A diagnosis of myelofibrosis, including myelofibrosis that developed after polycythaemia vera or essential thrombocythaemia, confirmed by a recent pathology report
- An enlarged spleen measuring at least 450 cm³ on a scan (MRI or CT) done within 28 days before the first dose
- An intermediate or high risk score on the DIPSS risk scale (intermediate-1 with symptoms, intermediate-2, or high risk)
- Being well enough for daily activities (performance status score of 2 or less)
- A platelet count of at least 50 x 10⁹/L without a platelet transfusion in the previous 7 days
- A neutrophil (a type of white blood cell) count of at least 1.0 x 10⁹/L without growth factor medicine in the previous 7 days
- Healthy enough liver function (certain liver blood tests within set limits)
- Kidney function (creatinine clearance) above 15 mL/min
- Active myelofibrosis symptoms, shown by specific scores on a symptom questionnaire (MFSAF version 4.0) kept daily for at least 7 days before the first dose
- Willing to give bone marrow biopsy samples (samples from up to 3 months before the first dose are allowed) at screening and during the study
- Not currently eligible for a stem cell transplant
- Willing to complete the symptom questionnaire daily during the study
Who may not be able to
- More than 10% blast cells in the blood or bone marrow (a more advanced phase of the disease)
- Previous treatment with JAK inhibitors for myelofibrosis
- Previous treatment with selinexor or other drugs that block XPO1
- Pregnancy or breastfeeding
- Having had the spleen removed, spleen radiotherapy, or a spleen embolisation within 6 months before the first dose
- A heart attack, unstable angina, heart procedures (angioplasty or bypass), stroke or mini-stroke, serious heart rhythm problems, or moderate-to-severe heart failure within 6 months before the first dose
- Being unable to take two types of anti-sickness medicines before each dose for the first two treatment cycles
What taking part involves
- • Taking the study drug selinexor on its own (no other anti-cancer drugs) — dose details not stated, ask the trial team
- • Daily completion of a myelofibrosis symptom questionnaire (MFSAF version 4.0)
- • Bone marrow biopsies at screening and during the study
- • Spleen scans (MRI or CT) — how often is not stated, ask the trial team
Time commitment: Taking selinexor at home or at the clinic (not stated, ask the trial team), daily symptom questionnaires, bone marrow biopsies, and study visits — visit frequency and total study duration are not stated, ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 58
- Started
- 2024-04-22
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for myelofibrosis
- • Phase2 - 58 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with myelofibrosis
Where?
- • London - Guy's and Saint Thomas' NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
MyelofibrosisModerate ThrombocytopeniaMild Thrombocytopenia
How this trial compares with your answers
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What we know so far
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓A diagnosis of MF or post-ET or post-PV MF according to the 2016 World Health Organization (WHO) classification of...
- ✓DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk
- ✓ECOG Performance Status less than or equal to (\<=) 2
- ✓blood clotting cell count of greater than or equal to (\>=) 50 x 10\^9/L without platelet transfusion within 7 days prior to...
- ✓infection-fighting white blood cell count (ANC) \>=1.0 × 10\^9/L without need for growth factors within 7 days prior to the first...
Who cannot take part
- ✗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
See the full criteria
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
Where Is This Study? (1 UK site)
Guy's and Saint Thomas' NHS Foundation Trust
London SE1 9RT, United Kingdom
Site contact (verified)
Jennifer O'SullivanPrincipal Investigator
How to Get in Touch
Karyopharm Medical Information
Sponsor contactCONTACT
(888) 209-9326 clinicaltrials@karyopharm.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-02