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New combo pill aims to shrink spleens and ease symptoms in bone marrow cancer

NCT ID NCT04562389

Disease control Sponsor: Karyopharm Therapeutics Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding the drug selinexor to the standard treatment ruxolitinib works better than ruxolitinib alone for people with myelofibrosis, a type of bone marrow cancer. About 353 adults who have not yet been treated for their condition will take either the combination or a placebo plus ruxolitinib. The main goals are to see if the combination reduces spleen size and improves symptoms like fatigue and pain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
selinexor (a drug that blocks a protein helping cancer cells survive) combined with ruxolitinib (a standard drug for myelofibrosis)
What this could lead to
If successful, this combination could offer a more effective first-line treatment for myelofibrosis, reducing spleen size and improving symptoms better than the current standard.
What could go wrong
This is an early-to-mid stage trial; the combination may cause more side effects than ruxolitinib alone, and it is not yet known if it improves survival. Results are still pending.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

353 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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.

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Conditions

The condition(s) this trial relates to.

myelofibrosis Myeloproliferative Disorders primary myelofibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelofibrosis

Contacts and locations

Locations

  • AIDPORT

    Skórzewo, Greater Poland Voivodeship, 60-185, Poland

  • Aarhus Universitetshospital

    Aarhus N, Central Jutland, 8200, Denmark

  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

    Bruges, West-Vlaanderen, 8000, Belgium

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 10128, Italy

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, 50134, Italy

  • Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico

    Catania, Catania, 95123, Italy

  • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

    Torino, Turin, 10126, Italy

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    Novara, Novara, 28100, Italy

  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi

    Bologna, 40138, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, Milan, 20162, Italy

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales, 2200, Australia

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560, Australia

  • Carmel Medical Center

    Haifa, Haifa District, 3436212, Israel

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

  • Centre Hospitalier Universitaire Estaing

    Clermont-Ferrand, Aubergne, 63003, France

  • Centre Hospitalier Universitaire d'Angers

    Angers, Pays de la Loire Region, 49 933, France

  • Centre Hospitalier Universitaire de Saint-Étienne

    Saint-Priest-en-Jarez, Pays de la Loire Region, 42271, France

  • Centro Ricerche Cliniche di Verona

    Verona, 37134, Italy

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, 83301, Taiwan

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan, 33305, Taiwan

  • China Medical University Hospital

    Taichung, Taichung, 40447, Taiwan

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128, South Korea

  • Chu De Nîmes - Institut De Cancérologie Du Gard

    Nîmes, Gard, 30029, France

  • City of Hope

    Duarte, California, 91010, United States

  • City of Hope - Irvine Lennar - Satellite

    Irvine, California, 92618, United States

  • Coltea - Spital Clinic

    Bucharest, 020125, Romania

  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico

    Salamanca, 37007, Spain

  • Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

    Wroclaw, Lower Silesian Voivodeship, 53-439, Poland

  • Duke Cancer Institue

    Durham, North Carolina, 27705, United States

  • Emek Medical Center

    Afula, Northern District, 1834111, Israel

  • Fakultní Nemocnice Hradec Králové

    Hradec Králové, 500 05, Czechia

  • Fakultní Nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

    Milan, Milan, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Monza and Brianza, 20900, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168, Italy

  • Fred Hutchinson Cancer Center - SCAA South Lake Union

    Seattle, Washington, 98109, United States

  • General Hospital of Athens "Alexandra"

    Athens, Attica, 115 28, Greece

  • General Hospital of Thessaloniki George Papanikolaou

    Thessaloniki, Central Macedonia, 570 10, Greece

  • Georgetown Lombardi Comprehensive Center

    Washington D.C., District of Columbia, 20007, United States

  • Guy's and St Thomas' NHS Foundation Trust

    London, England, SE1 9RT, United Kingdom

  • Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

    Győr, Győr-Moson-Sopron, 9023, Hungary

  • Hadassah University Hospital - Mount Scopus - Satellite Site

    Jerusalem, Jerusalem, 9112001, Israel

  • Hadassah University Hospital Ein Kerem

    Jerusalem, Jerusalem, 9112001, Israel

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital San Pedro de Alcantara

    Cáceres, Cáceres, 10003, Spain

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Lucus Augusti

    Lugo, 27003, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, 35010, Spain

  • Hospital de Día Quirónsalud Zaragoza

    Zaragoza, Zaragoza, 50012, Spain

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Hôpital Bretonneau

    Tours, Indre-et-Loire, 37044, France

  • Hôpital Cochin

    Paris, Île-de-France Region, 75014, France

  • Hôpital Emile Muller

    Mulhouse, Grand Est, 68100, France

  • Hôpital Huriez

    Lille, Hauts-de-France, 59037, France

  • Hôpital Morvan

    Brest, Brittany Region, 29200, France

  • Hôpital Saint-Louis

    Paris, 75010, France

  • Hôpital Universitaire Pitié Salpêtrière

    Paris, Île-de-France Region, 75013, France

  • Hôpital l'Archet - CHU Nice

    Nice, PACA, 06202, France

  • IRCCS Centro di Riferimento Oncologico di Basilicata

    Rionero in Vulture, Potenza, 85028, Italy

  • IRCCS Ospedale Policlinico San Martino

    Genova, Genoa, 16132, Italy

  • Icon Cancer Centre - Wesley

    South Brisbane, Queensland, 4101, Australia

  • Imperial College Healthcare NHS Trust

    London, W12 0HS, United Kingdom

  • Institut Bergonié

    Bordeaux, Aquitaine, 33000, France

  • Institut Català d&#39;Oncologia Girona (ICO Girona)

    Girona, 17007, Spain

  • Institut Català d'Oncologia Badalona

    Badalona, 08916, Spain

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, Cluj, 400015, Romania

  • Institutul Regional De Oncologie Iasi

    Iași, 700483, Romania

  • Istituto Europeo di Oncologia

    Milan, Milan, 20141, Italy

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST

    Meldola, Forli-Cesena, 47014, Italy

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd

    Mutlangen, Baden-Wurttemberg, 73557, Germany

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • Laiko General Hospital of Athens

    Athens, Attica, 115 27, Greece

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9, Canada

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Marien Hospital Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40479, Germany

  • Maryland Oncology Hematology

    Columbia, Maryland, 21044, United States

  • Maryland Oncology Hematology-Satellite

    Annapolis, Maryland, 21401, United States

  • Maryland Oncology Hematology-Satellite

    Brandywine, Maryland, 21004, United States

  • Maryland Oncology Hematology-Satellite

    Rockville, Maryland, 20850, United States

  • Maryland Oncology Hematology-Satellite

    Silver Spring, Maryland, 20904, United States

  • Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Toruń

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Mount Sinai Health System

    New York, New York, 10029, United States

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • Norton Cancer Institute - Saint Matthews

    Louisville, Kentucky, 40207, United States

  • Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210, United States

  • OhioHealth

    Columbus, Ohio, 43214, United States

  • One Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, England, OX3 7LE, United Kingdom

  • Pratia Onkologia Katowice

    Katowice, Silesian Voivodeship, 40-519, Poland

  • Pusan National University Hospital

    Busan, Gwang'Yeogsi, 49241, South Korea

  • Rambam Health Care Campus

    Haifa, Haifa District, 3109601, Israel

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Samsung Medical Center

    Seoul, 6351, South Korea

  • Semmelweis Egyetem

    Budapest, 1088, Hungary

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13605, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Shamir Medical Center (Assaf Harofeh)

    Be’er Ya‘aqov, Central District, 7030000, Israel

  • Smilow Cancer Hospital - New Haven

    New Haven, Connecticut, 06511, United States

  • Spaarne Gasthuis - Hoofddorp

    Hoofddorp, North Holland, 2134 TM, Netherlands

  • Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia

    Sofia, 1797, Bulgaria

  • Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu

    Wałbrzych, Silesian Voivodeship, 58-309, Poland

  • Spitalul Clinic Colentina

    Bucharest, 20125, Romania

  • Spitalul Clinic Judetean De Urgenta Târgu Mureș

    Târgu Mureş, Mureș County, 540136, Romania

  • Spitalul Filantropia - Craiova

    Craiova, Dolj, 200136, Romania

  • Städtisches Krankenhaus Kiel

    Kiel, Schleswig-Holstein, 24116, Germany

  • Szpital Specjalistyczny w Brzozowie - Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza

    Brzozów, Podkarpackie Voivodeship, 36-200, Poland

  • Tang Severinsen, Marianne

    Aalborg, North Denmark, 9000, Denmark

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Texas Oncology

    Dallas, Texas, 75246, United States

  • The Cancer & Hematology Centers -Satellite Site

    Grand Rapids, Michigan, 49546, United States

  • The Cancer & Hematology Centers of Muskegon

    Norton Shores, Michigan, 49444, United States

  • The Catholic University of Korea - Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • The Chaim Sheba Medical Center

    Ramat Gan, Central District, 5265601, Israel

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, LZ 8XP, United Kingdom

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • The Oncology Institute of Hope & Innovation

    Pasadena, California, 91105, United States

  • The Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21205, United States

  • UAB Division of Hematology/Oncology

    Birmingham, Alabama, 35294, United States

  • UCLA

    Los Angles, California, 90095, United States

  • UCLA - Satellite Site

    Beverly Hills, California, 90210, United States

  • UCLA - Satellite Site

    Encino, California, 93003, United States

  • USOR - Oncology Hematology Care - Kenwood

    Cincinnati, Ohio, 45242, United States

  • USOR - Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80045, United States

  • USOR - Virginia Cancer Specialists - Gainesville Office

    Gainesville, Virginia, 20155, United States

  • USOR - Virginia Oncology Associates - Virginia Beach

    Virginia Beach, Virginia, 23456, United States

  • Umberto I - Policlinico di Roma

    Roma, Rome, 00161, Italy

  • United Lincolnshire Hospitals NHS Trust

    Boston, PE21 9QS, United Kingdom

  • United Lincolnshire Hospitals NHS Trust-Satellite Site

    Boston, PE21 9QS, United Kingdom

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, Flemish Brabant, 3000, Belgium

  • University General Hospital Attikon

    Athens, Attica, 124 62, Greece

  • University General Hospital of Ioannina

    Ioánnina, Thessaly, 455 00, Greece

  • University General Hospital of Larissa, Hematology Department

    Larissa, Thessaly, 41110, Greece

  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich

    Stara Zagora, 6003, Bulgaria

  • University Multiprofile Hospital for Active Treatment Aleksandrovska

    Sofia, 1431, Bulgaria

  • University Multiprofile Hospital for Active Treatment St. Ivan Rilski

    Sofia, 1431, Bulgaria

  • University Multiprofile Hospital for Active Treatment Sveti George - Base 1

    Plovdiv, 4002, Bulgaria

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2G3, Canada

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792, United States

  • Università Campus Bio-Medico di Roma

    Rome, Viterbo, 00128, Italy

  • Universitätsklinikum Halle

    Halle, Saxony-Anhalt, 6120, Germany

  • Universitätsklinikum Jena

    Jena, Thuringia, 7747, Germany

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, Lublin Voivodeship, 20-093, Poland

  • Uniwersyteckie Centrum Kliniczne w Gdańsku

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • VCU Massey Cancer Center

    Richmond, Virginia, 23298, United States

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, Prague, 128 08, Czechia

  • West Virginia University Cancer Institute, Wheeling Hospital

    Wheeling, West Virginia, 26003, United States

  • Western Galilee Hospital-Nahariya

    Nahariya, Northern District, 2210001, Israel

  • ZNA Stuivenberg

    Antwerp, 2060, Belgium

  • ZNA Stuivenberg - Satelite

    Antwerp, 2030, Belgium

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