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

Last updated: February 10, 2026
Sponsor: Karyopharm Therapeutics Inc
Overall Status: Active - Recruiting

Phase

2

Condition

Thrombosis

Myelofibrosis

Dysfunctional Uterine Bleeding

Treatment

Selinexor 60 mg

Selinexor 40 mg

Pacritinib

Clinical Study ID

NCT05980806
XPORT-MF-044
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • A diagnosis of MF or post-ET or post-PV MF according to the 2016 World HealthOrganization (WHO) classification of MPN, confirmed by the most recent localpathology report

  • Measurable splenomegaly during the screening period as demonstrated by spleen volumeof greater than or equal to (>=) 450 cubic square centimeter (cm^3) by MRI or CTscan (results from MRI or CT imaging performed within 28 days prior to C1D1 areacceptable)

  • 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 platelettransfusion within 7 days prior to the first dose of selinexor

  • Absolute neutrophil count (ANC) >=1.0 × 10^9/L without need for growth factorswithin 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 totalbilirubin <= 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 anaverage score >= 5 or total score of >= 12 at screening (at least 5 of 7 consecutivedays immediately preceding C1D1) using the MFSAF V4.0

  • Must provide bone marrow biopsy samples (samples obtained up to 3 months prior toC1D1 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 thesymptom response (i.e., TSS50)

Exclusion

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 monthsprior to C1D1

  • History of myocardial infarction, unstable angina, percutaneous transluminalcoronary angioplasty (PTCA), coronary artery bypass graft (CABG), cerebrovascularaccident (transient ischemic attack [TIA]), ventricular arrhythmias, congestiveheart failure class > 2 per New York Heart Association (NYHA) within 6 months ofC1D1

  • Unable to tolerate two forms of antiemetics prior to each dose for the first twocycles

Study Design

Total Participants: 58
Treatment Group(s): 6
Primary Treatment: Selinexor 60 mg
Phase: 2
Study Start date:
April 22, 2024
Estimated Completion Date:
October 31, 2028

Connect with a study center

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Gent

    Ghent 2797656, 9000
    Belgium

    Active - Recruiting

  • UZ Leuven - Campus Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • UZ Leuven - Campus Gasthuisberg

    Leuven 2792482, 3000
    Belgium

    Active - Recruiting

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

    Plovdiv, 4002
    Bulgaria

    Site Not Available

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

    Plovdiv 728193, 4002
    Bulgaria

    Active - Recruiting

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

    Sofia, 1756
    Bulgaria

    Active - Recruiting

  • University Hospital Sv.Ivan Rilski - Sofia

    Sofia, 1431
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Aleksandrovska

    Sofia, 1431
    Bulgaria

    Active - Recruiting

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

    Sofia 727011, 1756
    Bulgaria

    Active - Recruiting

  • University Hospital Sv.Ivan Rilski - Sofia

    Sofia 727011, 1431
    Bulgaria

    Active - Recruiting

  • University Multiprofile Hospital for Active Treatment Aleksandrovska

    Sofia 727011, 1431
    Bulgaria

    Active - Recruiting

  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology

    Stara Zagora, 6003
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology

    Stara Zagora 726848, 6003
    Bulgaria

    Active - Recruiting

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Research Institute of the McGill University Health Centre

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Active - Recruiting

  • Fakultní nemocnice Olomouc

    Olomouc 3069011, 779 00
    Czechia

    Active - Recruiting

  • Aarhus Universitetshospital

    Aarhus N 11746890, Central Jutland 6418539 8200
    Denmark

    Active - Recruiting

  • Institut Bergonié

    Bordeaux 3031582, Aquitaine 33000
    France

    Active - Recruiting

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite 2987314, Auvergne-Rhône-Alpes 11071625 69495
    France

    Active - Recruiting

  • CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire

    Tours 2972191, Indre-et-Loire 37044
    France

    Active - Recruiting

  • CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire

    Tours Cedex 01, Indre-et-Loire 37044
    France

    Site Not Available

  • Chu De Nîmes - Institut De Cancérologie Du Gard

    Nîmes, Occitanie 30029
    France

    Site Not Available

  • Chu De Nîmes - Institut De Cancérologie Du Gard

    Nîmes 2990363, Occitanie 11071623 30029
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire d'Angers

    Angers, Pays de la Loire 49 933
    France

    Site Not Available

  • Centre Hospitalier Universitaire d'Angers

    Angers 3037656, Pays de la Loire Region 2988289 49 933
    France

    Active - Recruiting

  • Centre Hospitalier Lyon-Sud

    Pierre Bénite, Rhone-Alpes 69495
    France

    Site Not Available

  • Hôpital Cochin

    Paris, 75014
    France

    Active - Recruiting

  • Hôpital Saint-Louis

    Paris, 75010
    France

    Site Not Available

  • Hôpital Cochin

    Paris 2988507, 75014
    France

    Active - Recruiting

  • Hôpital Saint-Louis

    Paris 2988507, 75010
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Saint-Etienne

    Saint-Priest-en-Jarez, 42270
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Saint-Etienne

    Saint-Priest-en-Jarez 2977350, 42270
    France

    Active - Recruiting

  • Marien Hospital Düsseldorf

    Düsseldorf, 40479
    Germany

    Site Not Available

  • Marien Hospital Düsseldorf

    Düsseldorf 2934246, 40479
    Germany

    Active - Recruiting

  • University Hospital Jena

    Jena, 7747
    Germany

    Site Not Available

  • University Hospital Jena

    Jena 2895044, 7747
    Germany

    Active - Recruiting

  • Laiko General Hospital of Athens

    Athens 264371, Attica 6692632 11527
    Greece

    Active - Recruiting

  • University General Hospital Attikon

    Athens 264371, Attica 6692632 124 62
    Greece

    Active - Recruiting

  • "Georgios Papanikolaou" General Hospital of Thessaloniki

    Thessaloniki 734077, Central Macedonia 6697801 57010
    Greece

    Active - Recruiting

  • University General Hospital of Ioannina, Hematology Department

    Ioannina 261779, Epirus 6697804 45500
    Greece

    Active - Recruiting

  • University General Hospital of Larissa, Hematology Department

    Larissa 258576, Thessaly 6697809 41110
    Greece

    Active - Recruiting

  • Semmelweis Egyetem

    Budapest, 1088
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest 3054643, 1088
    Hungary

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv 293397, Tel Aviv 293396 6423906
    Israel

    Active - Recruiting

  • Carmel Medical Center

    Haifa 294801, 3436212
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa 294801, 3109601
    Israel

    Active - Recruiting

  • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

    Milan 3173435, Milan 20122
    Italy

    Active - Recruiting

  • Hematology Division, Mauriziano Hospital, University of Turin

    Orbassano, Torino 10043
    Italy

    Site Not Available

  • Hematology Division, Mauriziano Hospital, University of Turin

    Orbassano 3171986, Torino 10043
    Italy

    Active - Recruiting

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

    Torino 8980539, Turin 10126
    Italy

    Active - Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna 3181928, 40138
    Italy

    Active - Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132
    Italy

    Site Not Available

  • IRCCS Ospedale Policlinico San Martino

    Genova 8969657, 16132
    Italy

    Active - Recruiting

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

    Meldola,
    Italy

    Site Not Available

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

    Meldola 3173635,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

    Milan, 20122
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan 6951411, 20162
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia

    Milan 6951411, 20141
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia

    Milano, 20141
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    Novara 3172189, 28100
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia 3171366, 27100
    Italy

    Active - Recruiting

  • Università Campus Bio-Medico di Roma

    Rome, 128
    Italy

    Site Not Available

  • Università Campus Bio-Medico di Roma

    Rome 3169070, 128
    Italy

    Active - Recruiting

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

    Seocho-gu, Seoul 6591
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul, Seoul Teugbyeolsi 3722
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan-si, 49241
    Korea, Republic of

    Site Not Available

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM
    Netherlands

    Site Not Available

  • Spaarne Gasthuis

    Hoofddorp 2753801, 2134 TM
    Netherlands

    Active - Recruiting

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin 765876, 20-954
    Poland

    Active - Recruiting

  • AIDPORT

    Skórzewo, 30 60-185
    Poland

    Site Not Available

  • AIDPORT

    Skórzewo 3085750, 30 60-185
    Poland

    Active - Recruiting

  • Medicover Clinical Integrated Systems Sp. z o.o.

    Torun 3083271, 87-100
    Poland

    Active - Recruiting

  • Medicover Clinical Integrated Systems Sp. z o.o.

    Toruń, 87-100
    Poland

    Site Not Available

  • Coltea - Spital Clinic

    Bucharest, 30167
    Romania

    Site Not Available

  • Coltea - Spital Clinic

    Bucharest 683506, 30167
    Romania

    Active - Recruiting

  • Spitalul Filantropia - Craiova

    Craiova, 200143
    Romania

    Site Not Available

  • Spitalul Filantropia - Craiova

    Craiova 680332, 200143
    Romania

    Active - Recruiting

  • Institutul Regional de Oncologie Iasi

    Iași 675810, 700483
    Romania

    Active - Recruiting

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

    Seocho 1836725, Seoul 1835847 6591
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, Seoul Teugbyeolsi 3080
    South Korea

    Active - Recruiting

  • Severance Hospital

    Seoul 1835848, Seoul Teugbyeolsi 3722
    South Korea

    Active - Recruiting

  • Pusan National University Hospital

    Busan 1838524, 49241
    South Korea

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Hospital Germans Trias i Pujol

    Badalona 3129028, Barcelona 8916
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia 30120
    Spain

    Site Not Available

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar 2518294, Murcia 2513413 30120
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo 3114711, Principality of Asturias 3114710 33011
    Spain

    Active - Recruiting

  • Hospital San Pedro de Alcantara

    Cáceres, 10003
    Spain

    Site Not Available

  • Hospital San Pedro de Alcantara

    Cáceres 2520611, 10003
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia Girona

    Girona, 17007
    Spain

    Site Not Available

  • Institut Català d'Oncologia Girona

    Girona 3121456, 17007
    Spain

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas De Gran Canaria, 35010
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria 2515270, 35010
    Spain

    Active - Recruiting

  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico

    Salamanca, 37007
    Spain

    Site Not Available

  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico

    Salamanca 3111108, 37007
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia 2509954, 46010
    Spain

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City 1673820, 807
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei 1668341, 100
    Taiwan

    Active - Recruiting

  • Taoyuan Chang Gung Memorial Hospital

    Taoyuan District 1667905, 333
    Taiwan

    Active - Recruiting

  • Guy's and Saint Thomas' NHS Foundation Trust

    London 2643743, SE1 9RT
    United Kingdom

    Active - Recruiting

  • City of Hope - Duarte Main Site

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope - Duarte Main Site

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • Maryland Oncology Hematology - Independent of SCRI/ US Oncology

    Columbia, Maryland 21044
    United States

    Site Not Available

  • Maryland Oncology Hematology - Independent of SCRI/ US Oncology

    Columbia 4352053, Maryland 4361885 21044
    United States

    Active - Recruiting

  • Weill Cornell Medicine NewYork-Presbyterian

    New York, New York 10021
    United States

    Site Not Available

  • Weill Cornell Medicine NewYork-Presbyterian

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Duke University

    Durham 4464368, North Carolina 4482348 27705
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • MD Anderson

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Active - Recruiting

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