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NCT05980806RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 12 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
58 (estimated)
First submitted
24 Jul 2023
Start date
22 Apr 2024
Primary completion date
Jun 2027
Lead sponsor
Karyopharm Therapeutics Inc
NCT number
NCT05980806

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 58
  • From 22 Apr 2024 to the primary completion date, Jun 2027
  • 70 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)
  • Females who are pregnant or lactating

Who 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 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (70)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
UZ Gent
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GhentBelgiumRecruiting
Uz Leuven Campus Gasthuisberg
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LeuvenBelgiumRecruiting
University Multiprofile Hospital for Active Treatment Sveti George - Base 1
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PlovdivBulgariaRecruiting
University Multiprofile Hospital for Active Treatment Aleksandrovska
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SofiaBulgariaRecruiting
Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
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SofiaBulgariaRecruiting
University Hospital Sv.Ivan Rilski - Sofia
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SofiaBulgariaRecruiting
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology
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Stara ZagoraBulgariaRecruiting
Research Institute of the McGill University Health Centre
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MontrealCanadaRecruiting
Fakultni nemocnice Olomouc
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OlomoucCzechiaRecruiting
Marien Hospital Düsseldorf
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DüsseldorfGermanyRecruiting
University Hospital Jena
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JenaGermanyRecruiting
Aarhus Universitetshospital
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Aarhus NDenmarkRecruiting
Hospital Germans Trias i Pujol
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BadalonaSpainRecruiting
Hospital San Pedro De Alcántara
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CáceresSpainRecruiting
Hospital Clínico Universitario Virgen de la Arrixaca
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El PalmarSpainRecruiting
Institut Català D'Oncologia Girona
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GironaSpainRecruiting
Hospital Universitario de Gran Canaria Doctor Negrín
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Las Palmas de Gran CanariaSpainRecruiting
Hospital Universitario Central De Asturias
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OviedoSpainRecruiting
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
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SalamancaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire D'Angers
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AngersFranceRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
CHU de Nîmes - Institut de Cancérologie du Gard
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NîmesFranceRecruiting
Hôpital Cochin
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ParisFranceRecruiting
Hopital Saint Louis
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ParisFranceRecruiting
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceRecruiting
CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire
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ToursFranceRecruiting
Guy's and Saint Thomas' NHS Foundation Trust
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LondonUnited KingdomRecruiting
University General Hospital Attikon
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AthensGreeceRecruiting
Laiko General Hospital of Athens
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AthensGreeceRecruiting
University General Hospital of Ioannina, Hematology Department
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IoanninaGreeceRecruiting
University General Hospital of Larissa, Hematology Department
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LarissaGreeceRecruiting
Georgios Papanikolaou General Hospital of Thessaloniki
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ThessalonikiGreeceRecruiting
Semmelweis Egyetem
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BudapestHungaryRecruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Carmel Medical Center
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HaifaIsraelRecruiting
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelRecruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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BolognaItalyRecruiting
IRCCS Ospedale Policlinico San Martino
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GenovaItalyRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
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MeldolaItalyRecruiting
Istituto Europeo di Oncologia
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MilanItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
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NovaraItalyRecruiting
Hematology Division, Mauriziano Hospital, University of Turin
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OrbassanoItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
Università Campus Bio-Medico di Roma
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RomeItalyRecruiting
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
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TorinoItalyRecruiting
Pusan National University Hospital
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BusanSouth KoreaRecruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
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SeochoSouth KoreaRecruiting
Severance hospital
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Spaarne Gasthuis
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HoofddorpNetherlandsRecruiting
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
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LublinPolandRecruiting
Aidport
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SkorzewoPolandRecruiting
Medicover Clinical Integrated Systems Sp. z o.o.
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TorunPolandRecruiting
Coltea - Spital Clinic
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BucharestRomaniaRecruiting
Spitalul Filantropia - Craiova
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CraiovaRomaniaRecruiting
Institutul Regional de Oncologie Iasi
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IașiRomaniaRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Taoyuan Chang Gung Memorial Hospital
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TaoyuanTaiwanRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Maryland Oncology Hematology - Independent of SCRI/ US Oncology
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ColumbiaUnited StatesRecruiting
City of Hope - Duarte Main Site
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DuarteUnited StatesRecruiting
Duke University
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DurhamUnited StatesRecruiting
MD Anderson
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HoustonUnited StatesRecruiting
Weill Cornell Medicine | NewYork-Presbyterian
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New YorkUnited StatesRecruiting
Huntsman Cancer Institute
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Salt Lake CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.