Evaluating Selinexor for Myelofibrosis with Low Platelet Counts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness of selinexor in patients with myelofibrosis who have not previously received JAK inhibitors and have moderate thrombocytopenia. Participants will be evaluated based on the reduction in spleen volume and other efficacy and safety parameters. The study will involve administering different doses of selinexor and monitoring the participants' responses over time. The goal is to provide insights into the potential benefits of selinexor for this specific patient population.

Why it matters

Who can join: the full rules

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 it's running

• City of Hope - Duarte Main Site
  Duarte, California, United States Recruiting
• Maryland Oncology Hematology - Independent of SCRI/ US Oncology
  Columbia, Maryland, United States Recruiting
• Weill Cornell Medicine NewYork-Presbyterian
  New York, New York, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• MD Anderson
  Houston, Texas, United States Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Karyopharm Medical Information
• Email: clinicaltrials@karyopharm.com
• Phone: (888) 209-9326

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MPN PROGRESSion Registry — tracking symptoms, treatments, and disease progression in people with MPNs.

  Track long-term symptoms, treatments, and disease progression in adults with myeloproliferative neoplasms to see how these conditions evolve over time.

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• Nelfinavir to improve anemia in people with myelofibrosis by restoring iron delivery to the bone marrow

  This trial tests whether the antiviral drug nelfinavir can help people with myelofibrosis and anemia by raising hemoglobin and lowering blood markers of fibrosis.

  Recruiting Phase 1/2 University of California, Irvine · Orange, California · NCT07281781

• National registry for people with myelofibrosis and anemia in Germany.

  This project will collect health, treatment, and quality-of-life information from people in Germany with primary or secondary myelofibrosis and anemia to see how their care and symptoms change over time.

  Recruiting iOMEDICO AG · Multiple Locations · NCT06976918

• Evaluating DISC-0974 for treating anemia in myelofibrosis patients

  This study tests if a new treatment called DISC-0974 can help people with myelofibrosis who have anemia feel better and improve their condition.

  Recruiting at 33 sites Phase 1/2 Disc Medicine, Inc · Gilbert, Arizona and 34 other locations · NCT05320198

• Elritercept vs. placebo for adults with myelofibrosis and anemia on ruxolitinib

  This study tests whether elritercept can improve anemia in adults with myelofibrosis who are taking ruxolitinib, compared with placebo.

  Recruiting at 11 sites Phase 3 Takeda · Gilbert, Arizona and 213 other locations · NCT07623161

• TQ05105 tablets for intermediate/high-risk myelofibrosis

  This phase 2 study tests TQ05105 tablets to see if they help people with intermediate or high-risk myelofibrosis who have not benefited from prior JAK inhibitors.

  Recruiting at 24 sites Phase 2 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Hefei, Anhui and 23 other locations · NCT07551427

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.