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
- Diseases
- Myeloproliferative neoplasms
- 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
Sites (70)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Uz Leuven Campus Gasthuisberg Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| University Multiprofile Hospital for Active Treatment Sveti George - Base 1 Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| University Multiprofile Hospital for Active Treatment Aleksandrovska Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| University Hospital Sv.Ivan Rilski - Sofia Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Recruiting |
| Research Institute of the McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Fakultni nemocnice Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| Marien Hospital Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
| University Hospital Jena Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital San Pedro De Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Recruiting |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | El Palmar | Spain | Recruiting |
| Institut Català D'Oncologia Girona Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
| Hospital Universitario de Gran Canaria Doctor Negrín Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Complejo Asistencial Universitario de Salamanca - Hospital Clínico Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU de Nîmes - Institut de Cancérologie du Gard Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| Guy's and Saint Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital of Ioannina, Hematology Department Coordinator of this site? Confirm its status | Ioannina | Greece | Recruiting |
| University General Hospital of Larissa, Hematology Department Coordinator of this site? Confirm its status | Larissa | Greece | Recruiting |
| Georgios Papanikolaou General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| Istituto Europeo di Oncologia Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carita di Novara Coordinator of this site? Confirm its status | Novara | Italy | Recruiting |
| Hematology Division, Mauriziano Hospital, University of Turin Coordinator of this site? Confirm its status | Orbassano | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Università Campus Bio-Medico di Roma Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Seoul St. Mary's Hospital, The Catholic University of Korea Coordinator of this site? Confirm its status | Seocho | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Spaarne Gasthuis Coordinator of this site? Confirm its status | Hoofddorp | Netherlands | Recruiting |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Aidport Coordinator of this site? Confirm its status | Skorzewo | Poland | Recruiting |
| Medicover Clinical Integrated Systems Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| Coltea - Spital Clinic Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Filantropia - Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Institutul Regional de Oncologie Iasi Coordinator of this site? Confirm its status | Iași | Romania | Recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taoyuan Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Maryland Oncology Hematology - Independent of SCRI/ US Oncology Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| City of Hope - Duarte Main Site Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| MD Anderson Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Weill Cornell Medicine | NewYork-Presbyterian Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.