A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia (SENTRY-2)

February 10, 2026 updated by: Karyopharm Therapeutics Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Principal Investigator:
          • Dominiek Mazure
        • Contact:
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven - Campus Gasthuisberg
        • Principal Investigator:
          • Timothy Devos
        • Contact:
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • University Multiprofile Hospital for Active Treatment Sveti George - Base 1
        • Principal Investigator:
          • Zhanet Grudeva-Popova
        • Contact:
      • Sofia, Bulgaria, 1431
        • Recruiting
        • University Multiprofile Hospital for Active Treatment Aleksandrovska
        • Contact:
        • Principal Investigator:
          • Evgueniy Hadjiev
      • Sofia, Bulgaria, 1756
        • Recruiting
        • Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
        • Contact:
        • Principal Investigator:
          • Martin Donchev
      • Sofia, Bulgaria, 1431
        • Recruiting
        • University Hospital Sv.Ivan Rilski - Sofia
        • Principal Investigator:
          • Atanas Radinoff
        • Contact:
      • Stara Zagora, Bulgaria, 6003
        • Recruiting
        • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology
        • Contact:
        • Principal Investigator:
          • Mariya Todorova
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Research Institute of the McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Jonathan How
  • Czechia
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Fakultni Nemocnice Olomouc
        • Contact:
        • Principal Investigator:
          • Antonín Hluší
  • Denmark
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital
        • Contact:
          • Peter Buur van Kooten Niekerk
          • Phone Number: +45 2388 6732
          • Email: petevank@rm.dk
        • Principal Investigator:
          • Peter Buur van Kooten Niekerk
  • France
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis
        • Principal Investigator:
          • Jean-Jacques Kiladjian
        • Contact:
      • Paris, France, 75014
        • Recruiting
        • Hôpital Cochin
        • Contact:
        • Principal Investigator:
          • Lise Willems
      • Saint-Priest-en-Jarez, France, 42270
        • Recruiting
        • Centre Hospitalier Universitaire de Saint-Étienne
        • Contact:
        • Principal Investigator:
          • Philippe Renaudier
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • Recruiting
        • Institut Bergonie
        • Contact:
        • Principal Investigator:
          • Gabriel Etienne
    • Auvergne-Rhône-Alpes
      • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon-Sud
        • Principal Investigator:
          • Fiorenza BARRACO
        • Contact:
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37044
        • Recruiting
        • CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire
        • Contact:
        • Principal Investigator:
          • Antoine Machet
    • Occitanie
      • Nîmes, Occitanie, France, 30029
        • Recruiting
        • CHU de NÎMES - Institut de Cancérologie du Gard
        • Contact:
        • Principal Investigator:
          • Stefan Wickenhauser
    • Pays de la Loire Region
      • Angers, Pays de la Loire Region, France, 49 933
        • Recruiting
        • Centre Hospitalier Universitaire d'Angers
        • Contact:
        • Principal Investigator:
          • Françoise Boyer-Perrard
  • Germany
      • Düsseldorf, Germany, 40479
        • Recruiting
        • Marien Hospital Düsseldorf
        • Contact:
        • Principal Investigator:
          • Stefanie Groepper
      • Jena, Germany, 7747
        • Recruiting
        • University Hospital Jena
        • Contact:
        • Principal Investigator:
          • Carl Crodel
  • Greece
    • Attica
      • Athens, Attica, Greece, 11527
        • Recruiting
        • Laiko General Hospital of Athens
        • Principal Investigator:
          • Panayiotis Panayiotidis
        • Contact:
      • Athens, Attica, Greece, 124 62
        • Recruiting
        • University General Hospital Attikon
        • Principal Investigator:
          • Panagiotis Tsirigotis
        • Contact:
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece, 57010
        • Recruiting
        • "Georgios Papanikolaou" General Hospital of Thessaloniki
        • Contact:
        • Principal Investigator:
          • Damianos Sotiropoulos
    • Epirus
      • Ioannina, Epirus, Greece, 45500
        • Recruiting
        • University General Hospital of Ioannina, Hematology Department
        • Principal Investigator:
          • Eleftheria Hatzimichael
        • Contact:
    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • Recruiting
        • University General Hospital of Larissa, Hematology Department
        • Principal Investigator:
          • George Vassilopoulos
        • Contact:
  • Hungary
      • Budapest, Hungary, 1088
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Principal Investigator:
          • Noa Lavi
        • Contact:
      • Haifa, Israel, 3436212
        • Recruiting
        • Carmel Medical Center
        • Principal Investigator:
          • Elena Mishchenko
        • Contact:
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Principal Investigator:
          • Ilya Kirgner
        • Contact:
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Principal Investigator:
          • FRANCESCA PALANDRI
        • Contact:
      • Genova, Italy, 16132
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
        • Principal Investigator:
          • Roberto Lemoli
        • Contact:
      • Meldola, Italy
        • Recruiting
        • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST
        • Principal Investigator:
          • Alessandro Lucchesi
        • Contact:
      • Milan, Italy, 20162
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
        • Principal Investigator:
          • Marianna Caramella
        • Contact:
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo Di Oncologia
        • Principal Investigator:
          • Federica Gigli
        • Contact:
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
        • Principal Investigator:
          • Andrea Patriarca
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Principal Investigator:
          • Elisa Rumi
        • Contact:
      • Rome, Italy, 128
        • Recruiting
        • Università Campus Bio-Medico di Roma
        • Principal Investigator:
          • Luigi Rigacci
        • Contact:
    • Milan
      • Milan, Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
        • Principal Investigator:
          • Alessandra Iurlo
        • Contact:
    • Torino
      • Orbassano, Torino, Italy, 10043
        • Recruiting
        • Hematology Division, Mauriziano Hospital, University of Turin
        • Principal Investigator:
          • Daniela Cilloni
        • Contact:
    • Turin
      • Torino, Turin, Italy, 10126
        • Recruiting
        • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
        • Contact:
        • Principal Investigator:
          • Eloise Beggiato
  • Netherlands
      • Hoofddorp, Netherlands, 2134 TM
        • Recruiting
        • Spaarne Gasthuis
        • Principal Investigator:
          • Aart Beeker
        • Contact:
  • Poland
      • Lublin, Poland, 20-954
        • Recruiting
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
        • Principal Investigator:
          • Krzysztof Giannopoulos
        • Contact:
      • Skórzewo, Poland, 30 60-185
        • Recruiting
        • Aidport
        • Principal Investigator:
          • Michał Kwiatek
        • Contact:
      • Torun, Poland, 87-100
        • Recruiting
        • Medicover Clinical Integrated Systems Sp. z o.o.
        • Contact:
        • Principal Investigator:
          • Dominik Charaniuk
  • Romania
      • Bucharest, Romania, 30167
        • Recruiting
        • Coltea - Spital Clinic
        • Principal Investigator:
          • Gabriela Borsaru
        • Contact:
      • Craiova, Romania, 200143
        • Recruiting
        • Spitalul Filantropia - Craiova
        • Principal Investigator:
          • Luminita Ocroteala
        • Contact:
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie Iasi
        • Contact:
        • Principal Investigator:
          • Catalin Doru Danaila
  • South Korea
      • Busan, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
        • Principal Investigator:
          • HoJin Shin
        • Contact:
    • Seoul
      • Seocho, Seoul, South Korea, 6591
        • Recruiting
        • Seoul St. Mary's Hospital, The Catholic University of Korea
        • Principal Investigator:
          • Sung-Eun Lee
        • Contact:
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 3080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Junshik Hong
        • Contact:
      • Seoul, Seoul Teugbyeolsi, South Korea, 3722
        • Recruiting
        • Severance Hospital
        • Contact:
        • Principal Investigator:
          • June-Won Cheong
  • Spain
      • Cáceres, Spain, 10003
        • Recruiting
        • Hospital San Pedro De Alcantara
        • Contact:
        • Principal Investigator:
          • Victor Higuero Saavedra
      • Girona, Spain, 17007
        • Recruiting
        • Institut Catala d'Oncologia Girona
        • Principal Investigator:
          • Anna Angona
        • Contact:
      • Las Palmas de Gran Canaria, Spain, 35010
        • Recruiting
        • Hospital Universitario de Gran Canaria Doctor Negrin
        • Contact:
        • Principal Investigator:
          • Adrián Segura Diaz
      • Salamanca, Spain, 37007
        • Recruiting
        • Complejo Asistencial Universitario de Salamanca - Hospital Clínico
        • Principal Investigator:
          • Jesús Maria Hernández Rivas
        • Contact:
          • Jesús Maria Hernández Rivas
          • Phone Number: 34 923-26-04-02
          • Email: jmhr@usal.es
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
        • Principal Investigator:
          • Irene Pastor Galan
    • Barcelona
      • Badalona, Barcelona, Spain, 8916
        • Recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
        • Principal Investigator:
          • Blanca Xicoy
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Clinico Universitario Virgen de La Arrixaca
        • Contact:
        • Principal Investigator:
          • Raúl Perez López
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
        • Principal Investigator:
          • Maria Angeles Fernandez Rodriguez
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Hui Hao Hsiao
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Hsin-An Hou
        • Contact:
      • Taoyuan District, Taiwan, 333
        • Recruiting
        • Taoyuan Chang Gung Memorial Hospital
        • Principal Investigator:
          • Hung Chang
        • Contact:
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's and Saint Thomas' NHS Foundation Trust
        • Principal Investigator:
          • Jennifer O'Sullivan
        • Contact:
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope - Duarte Main Site
        • Principal Investigator:
          • Haris Ali
        • Contact:
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Recruiting
        • Maryland Oncology Hematology - Independent of SCRI/ US Oncology
        • Principal Investigator:
          • Mohit Narang
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine NewYork-Presbyterian
        • Contact:
        • Principal Investigator:
          • Ellen Ritche
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Lindsay Rein
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Aaron Gerds
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson
        • Principal Investigator:
          • Prithviraj Bose
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
        • Contact:
        • Principal Investigator:
          • Srinivas Tantravahi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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)

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 months prior to C1D1
  • 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
  • Unable to tolerate two forms of antiemetics prior to each dose for the first two cycles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Selinexor 60 mg (Arm 1)
Participants will receive selinexor 60 milligrams (mg) oral tablets once weekly (QW) (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment. Optional add-on medication dosing may be initiated based on Spleen Volume Reduction (SVR) values at Week 12 or Week 24 of treatment.
Drug: Selinexor 60 mg
Participants will receive selinexor 60 mg oral tablets QW.
Other Names:
  • KPT-330
Drug: Ruxolitinib
Participants will receive ruxolitinib per local package insert.
Other Names:
  • JAKAFI
Drug: Pacritinib
Participants will receive pacritinib per local package insert. For countries where not approved, 200 mg twice daily is the starting dose.
Other Names:
  • VONJO
Drug: Momelotinib
Participants will receive momelotinib per local package insert.
Other Names:
  • OJJAARA
Experimental: Selinexor 40 mg (Arm 2)
Participants will receive selinexor 40 mg oral tablets QW (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment. Optional add-on medication dosing may be initiated based on Spleen Volume Reduction (SVR) values at Week 12 or Week 24 of treatment.
Drug: Selinexor 40 mg
Participants will receive selinexor 40 mg oral tablets QW.
Other Names:
  • KPT-330
Drug: Ruxolitinib
Participants will receive ruxolitinib per local package insert.
Other Names:
  • JAKAFI
Drug: Pacritinib
Participants will receive pacritinib per local package insert. For countries where not approved, 200 mg twice daily is the starting dose.
Other Names:
  • VONJO
Drug: Momelotinib
Participants will receive momelotinib per local package insert.
Other Names:
  • OJJAARA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants with Spleen Volume Reduction ≥35% (SVR35) at Week 24
Time Frame: At Week 24
Measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan by Investigator assessment.
At Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Mean Change in Total Symptom Score (Abs-TSS) from baseline to Week 24
Time Frame: At Baseline and Week 24
Measured by the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.
At Baseline and Week 24
Incidence and severity of TEAEs, including TRAEs and SAEs
Time Frame: From Baseline to EoS (approximately 48 months)
Measured by the NCI CTCAE Grading Scale, v. 5, as assessed and graded by the Investigator
From Baseline to EoS (approximately 48 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karyopharm Therapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XPORT-MF-044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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