NCT04562389Active, not recruitingPhase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
This is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended Phase 2 dose (RP2D) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). Phase 3 (ongoing), double-blind, placebo-controlled part of the study comparing the efficacy and safety of combination therapy of selinexor + ruxolitinib with combination of placebo + ruxolitinib.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 353 (actual)
- First submitted
- 14 Sept 2020
- Start date
- 11 Mar 2021
- Primary completion date
- 20 Feb 2026
- Lead sponsor
- Karyopharm Therapeutics Inc
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT04562389
- EU CT number
- 2023-506139-13-00
- EudraCT number
- 2020-003883-19
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 353
- From 11 Mar 2021 to the primary completion date, 20 Feb 2026
- 166 sites in 20 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.
Other
- More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).
Who the study is looking for
- Aged ≥ 18 years
- A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF.
- Active symptoms of MF as determined by presence of at least 2 symptoms using the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.
- Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk.
- Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (\>=) 450 cubic centimeter (cm\^3) .
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (\<=) 2.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (166)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Bankstown-Lidcombe Hospital Coordinator of this site? Confirm its status | Bankstown | Australia | Unknown status |
| Campbelltown Hospital Coordinator of this site? Confirm its status | Campbelltown | Australia | Unknown status |
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| One Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Icon Cancer Centre Wesley Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| ZNA Stuivenberg Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| ZNA Stuivenberg - Satelite Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| University Multiprofile Hospital for Active Treatment Sveti George - Base 1 Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Unknown status |
| University Multiprofile Hospital for Active Treatment St. Ivan Rilski Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| University Multiprofile Hospital for Active Treatment Aleksandrovska Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Unknown status |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Research Institute of the McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Lakeridge Health Coordinator of this site? Confirm its status | Oshawa | Canada | Unknown status |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| Fakultni nemocnice Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Marien Hospital Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Universitätsklinikum Halle Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Universitätsklinikum Jena Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| Städtisches Krankenhaus Kiel Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
| Kliniken Ostalb Stauferklinikum Schwäbisch Gmünd Coordinator of this site? Confirm its status | Mutlangen | Germany | Unknown status |
| Tang Severinsen, Marianne Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
| Institut Català d'Oncologia Badalona Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital San Pedro De Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Unknown status |
| Institut Català d'Oncologia Girona (ICO Girona) Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hospital Universitario de Gran Canaria Doctor Negrín Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Complejo Asistencial Universitario de Salamanca - Hospital Clínico Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital de Dia Quironsalud Zaragoza Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Hopital Morvan Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Centre Hospitalier Universitaire Estaing Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Hopital Huriez Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital Emile Muller Coordinator of this site? Confirm its status | Mulhouse | France | Unknown status |
| Hôpital l'Archet - CHU Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| CHU de Nîmes - Institut de Cancérologie du Gard Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Hôpital Universitaire Pitié Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| Hopital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| United Lincolnshire Hospitals NHS Trust Coordinator of this site? Confirm its status | Boston | United Kingdom | Unknown status |
| United Lincolnshire Hospitals NHS Trust-Satellite Site Coordinator of this site? Confirm its status | Boston | United Kingdom | Unknown status |
| The Clatterbridge Cancer Centre NHS Foundation Trust Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's and St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| General Hospital of Athens - Alexandra Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Unknown status |
| University General Hospital of Larissa, Hematology Department Coordinator of this site? Confirm its status | Larissa | Greece | Unknown status |
| General Hospital of Thessaloniki ""George Papanikolaou"" Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Unknown status |
| Emek Medical Center Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| Shamir Medical Center Coordinator of this site? Confirm its status | Be’er Ya‘aqov | Israel | Unknown status |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah University Hospital - Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Hadassah University Hospital - Mount Scopus Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Galilee Medical Center Coordinator of this site? Confirm its status | Nahariya | Israel | Unknown status |
| The Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Istituto Europeo di Oncologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Maggiore della Carita di Novara Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| IRCCS Centro di Riferimento Oncologico di Basilicata Coordinator of this site? Confirm its status | Rionero in Vulture | Italy | Unknown status |
| Umberto I - Policlinico di Roma Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Università Campus Bio-Medico di Roma Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Azienda Ospedaliera Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Centro Ricerche Cliniche Di Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Spaarne Gasthuis - Hoofddorp Coordinator of this site? Confirm its status | Hoofddorp | Netherlands | Unknown status |
| Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Coordinator of this site? Confirm its status | Brzozów | Poland | Unknown status |
| Uniwersyteckie Centrum Kliniczne w Gdańsku Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Pratia Onkologia Katowice Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Aidport Coordinator of this site? Confirm its status | Skorzewo | Poland | Unknown status |
| Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Toruń Coordinator of this site? Confirm its status | Torun | Poland | Unknown status |
| Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu Coordinator of this site? Confirm its status | Wałbrzych | Poland | Unknown status |
| Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Spitalul Clinic Colentina Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Coltea - Spital Clinic Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Institutul Oncologic Prof. Dr. Ion Chiricuta Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Spitalul Filantropia - Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Unknown status |
| Institutul Regional de Oncologie Iasi Coordinator of this site? Confirm its status | Iași | Romania | Unknown status |
| Spitalul Clinic Judetean de Urgenta Targu Mures Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chang Gung Memorial Hospital - Kaohsiung Branch Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital, Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Maryland Oncology Hematology-Satellite Coordinator of this site? Confirm its status | Annapolis | United States | Unknown status |
| USOR - Rocky Mountain Cancer Centers - Aurora Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| The Sidney Kimmel Comprehensive Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| UCLA - Satellite Site Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| UAB Division of Hematology/Oncology Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Maryland Oncology Hematology-Satellite Coordinator of this site? Confirm its status | Brandywine | United States | Unknown status |
| USOR - Oncology Hematology Care - Kenwood Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Maryland Oncology Hematology Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| OhioHealth Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Texas Oncology Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Duke Cancer Institue Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| UCLA - Satellite Site Coordinator of this site? Confirm its status | Encino | United States | Unknown status |
| USOR - Virginia Cancer Specialists - Gainesville Office Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| The Cancer & Hematology Centers -Satellite Site Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| John Theurer Cancer Center at Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| City of Hope - Irvine Lennar - Satellite Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| UCLA Coordinator of this site? Confirm its status | Los Angles | United States | Unknown status |
| Norton Cancer Institute - Saint Matthews Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Vanderbilt-Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Smilow Cancer Hospital - New Haven Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Mount Sinai Health System Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| The Cancer & Hematology Centers of Muskegon Coordinator of this site? Confirm its status | Norton Shores | United States | Unknown status |
| The Oncology Institute of Hope & Innovation Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| VCU Massey Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Maryland Oncology Hematology-Satellite Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Fred Hutchinson Cancer Center - SCAA South Lake Union Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Maryland Oncology Hematology-Satellite Coordinator of this site? Confirm its status | Silver Spring | United States | Unknown status |
| USOR - Virginia Oncology Associates - Virginia Beach Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
| Georgetown Lombardi Comprehensive Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| West Virginia University Cancer Institute, Wheeling Hospital Coordinator of this site? Confirm its status | Wheeling | United States | Unknown status |
Related publications
- Selinexor Plus Ruxolitinib in Janus Kinase Inhibitor-Naïve Myelofibrosis: Phase III SENTRY Trial.J Clin Oncol · 2026 · PMID 42227656
- Selinexor plus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis: a multicenter, open-label, phase 1 study.Blood Adv · 2026 · PMID 41785311
This page is information, not medical advice. Discuss any trial with your doctor.