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AzTrials

MyelofibrosisPhase 2SENTRY-2NCT05980806

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

A Phase 2 study testing Selinexor 60 mg, Selinexor 40 mg and Ruxolitinib in people with Myelofibrosis and Moderate Thrombocytopenia, run by Karyopharm Therapeutics Inc at 70 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Selinexor 60 mg, Selinexor 40 mg and Ruxolitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
70 sitesin 19 countries
Study dates
22 Apr 2024to Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

70 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Karyopharm Medical Information contact

(888) 209-9326

clinicaltrials@karyopharm.com

70 sites in 19 countries

Italy11 sites, 11 recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138

    Francesca Palandri, +39 0512144569, francesca.palandri@unibo.it

    Francesca Palandri

    Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

    Roberto Lemoli, +39 0103538978, roberto.lemoli@unige.it

    Roberto Lemoli

    Recruiting

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

    Meldola

    Alessandro Lucchesi, 39 054 3739 281, alessandro.lucchesi@irst.emr.it

    Alessandro Lucchesi

    Recruiting

  • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

    Milan, Milan, 20122

    Alessandra Iurlo, 39 0255033362, alessandra.iurlo@policlinico.mi.it

    Alessandra Iurlo

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Federica Gigli, +39 02574891, federica.gigli@ieo.it

    Federica Gigli

    Recruiting

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Marianna Caramella, +39 0264447597, marianna.caramella@ospedaleniguarda.it

    Marianna Caramella

    Recruiting

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    Novara, 28100

    Andrea Patriarca, 3909722726251, Andrea.patriarca@uniupo.it

    Andrea Patriarca

    Recruiting

  • Hematology Division, Mauriziano Hospital, University of Turin

    Orbassano, Torino, 10043

    Daniela Cilloni, 39 0115082224, daniela.cilloni@unito.it

    Daniela Cilloni

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Elisa Rumi, +39 0382-5011, e.rumi@smatteo.pv.it

    Elisa Rumi

    Recruiting

  • Università Campus Bio-Medico di Roma

    Rome, 128

    Luigi Rigacci, 39 06 58 70 3494, lrigacci@scamilloforlanini.rm.it

    Luigi Rigacci

    Recruiting

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

    Torino, Turin, 10126

    Eloise Beggiato, 30 0116334298, ebeggiato@cittadellasalute.to.it

    Eloise Beggiato

    Recruiting

Other trials in Italy

France8 sites, 8 recruiting

  • Centre Hospitalier Universitaire d'Angers

    Angers, Pays de la Loire Region, 49 933

    Françoise Boyer-Perrard, +33 2 41 35 54 50, FrBoyer-Perrard@chu-angers.fr

    Françoise Boyer-Perrard

    Recruiting

  • Institut Bergonié

    Bordeaux, Aquitaine, 33000

    Gabriel Etienne, +33 556 333 333, g.etienne@bordeaux.unicancer.fr

    Gabriel Etienne

    Recruiting

  • Chu De Nîmes - Institut De Cancérologie Du Gard

    Nîmes, Occitanie, 30029

    Stefan Wickenhauser, +33 4 66 68 40 33, stefan.wickenhauser@chu-nimes.fr

    Stefan Wickenhauser

    Recruiting

  • Hôpital Saint-Louis

    Paris, 75010

    Jean-Jacques Kiladjian, 33142499429, jean-jacques.kiladjian@sls.aphp.fr

    Jean-Jacques Kiladjian

    Recruiting

  • Hôpital Cochin

    Paris, 75014

    Lise Willems, +33 1 58 41 26 70, lise.willems@aphp.fr

    Lise Willems

    Recruiting

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

    Fiorenza Barraco, +33 4 78 50 16 63, fiorenza.barraco@chu-lyon.fr

    Fiorenza Barraco

    Recruiting

  • Centre Hospitalier Universitaire de Saint-Etienne

    Saint-Priest-en-Jarez, 42270

    Philippe Renaudier, +33 477917418, Philippe.renaudier@chu-st-etienne.fr

    Philippe Renaudier

    Recruiting

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

    Tours, Indre-et-Loire, 37044

    Antoine Machet, +33 2 47 47 37 12, a.machet@chu-tours.fr

    Antoine Machet

    Recruiting

Other trials in France

Spain8 sites, 8 recruiting

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 8916

    Xicoy Xicoy, +34 934978987, bxicoy@iconcologia.net

    Blanca Xicoy

    Recruiting

  • Hospital San Pedro de Alcantara

    Cáceres, 10003

    Victor Higuero Saavedra, +34 927 621 540, victor.higuero@salud-juntaex.es

    Victor Higuero Saavedra

    Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

    +34 968 36 95 00, raul.perez@carm.es

    Raúl Perez López

    Recruiting

  • Institut Català d'Oncologia Girona

    Girona, 17007

    +34 972225843, angona.figueras@iconcologia.net

    Anna Angona

    Recruiting

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, 35010

    Adrián Segura Diaz, +34 928450000, adsegura@hotmail.es

    Adrián Segura Diaz

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

    Maria Angeles Fernandez Rodriguez, +34 985 108000, ninesfr72@gmail.com

    Maria Angeles Fernandez Rodriguez

    Recruiting

  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico

    Salamanca, 37007

    Jesús Maria Hernández Rivas, 34 923-26-04-02, jmhr@usal.es

    Jesús Maria Hernández Rivas

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

    Irene Pastor Galan, +34 961973842, irenefisiomed@gmail.com

    Irene Pastor Galan

    Recruiting

Other trials in Spain

United States7 sites, 7 recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Aaron Gerds, 216-445-9840, gerdsa@ccf.org

    Aaron Gerds

    Recruiting

  • Maryland Oncology Hematology - Independent of SCRI/ US Oncology

    Columbia, Maryland, 21044

    Mohit Narang, 304-942-9220, mohit.narang@usoncology.com

    Mohit Narang

    Recruiting

  • City of Hope - Duarte Main Site

    Duarte, California, 91010

    Haris Ali, 6263564673, harisali@coh.org

    Haris Ali

    Recruiting

  • Duke University

    Durham, North Carolina, 27705

    Lindsay Rein, 919-684-8964, lindsay.magura@duke.edu

    Lindsay Rein

    Recruiting

  • MD Anderson

    Houston, Texas, 77030

    Prithviraj Bose, (713) 792-7747, PBose@mdanderson.org

    Prithviraj Bose

    Recruiting

  • Weill Cornell Medicine NewYork-Presbyterian

    New York, New York, 10021

    Ellen Ritche, 646-962-4580, ritchie@med.cornell.edu

    Ellen Ritche

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Srinivas Tantravahi, 801-213-6170, Srinivas.Tantravahi@hci.utah.edu

    Srinivas Tantravahi

    Recruiting

Other trials in United States

Bulgaria5 sites, 5 recruiting

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

    Plovdiv, 4002

    Zhanet Grudeva-Popova, 35932602877, dr_grudeva@yahoo.com

    Zhanet Grudeva-Popova

    Recruiting

  • University Hospital Sv.Ivan Rilski - Sofia

    Sofia, 1431

    Atanas Radinoff, +359 0240 3483 8, aradinoff@hotmail.com

    Atanas Radinoff

    Recruiting

  • University Multiprofile Hospital for Active Treatment Aleksandrovska

    Sofia, 1431

    Evgueniy Hadjiev, +35929230599 +359898901090, e_hadji58@yahoo.com

    Evgueniy Hadjiev

    Recruiting

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

    Sofia, 1756

    Martin Donchev, +359 877 676 134, martin.donchev@abv.bg

    Martin Donchev

    Recruiting

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

    Stara Zagora, 6003

    Mariya Todorova, +359 896 414 650, dr.maria.dtodorova@gmail.com

    Mariya Todorova

    Recruiting

Other trials in Bulgaria

Greece5 sites, 5 recruiting

  • Laiko General Hospital of Athens

    Athens, Attica, 11527

    Panayiotis Panayiotidis, +30 210-746-2183, ppanayi@med.uoa.gr

    Panayiotis Panayiotidis

    Recruiting

  • University General Hospital Attikon

    Athens, Attica, 124 62

    Panagiotis Tsirigotis, +302105832317; +30 21-07201000, panagtsirigotis@gmail.com

    Panagiotis Tsirigotis

    Recruiting

  • University General Hospital of Ioannina, Hematology Department

    Ioannina, Epirus, 45500

    Eleftheria Hatzimichael, ehatzim@uoi.gr

    Eleftheria Hatzimichael

    Recruiting

  • University General Hospital of Larissa, Hematology Department

    Larissa, Thessaly, 41110

    George Vassilopoulos, +306949207498, gvasilop@bioacademy.gr

    George Vassilopoulos

    Recruiting

  • "Georgios Papanikolaou" General Hospital of Thessaloniki

    Thessaloniki, Central Macedonia, 57010

    Damianos Sotiropoulos, +30 2313307000, dsotiro@otenet.gr

    Damianos Sotiropoulos

    Recruiting

Other trials in Greece

South Korea4 sites, 4 recruiting

  • Pusan National University Hospital

    Busan, 49241

    HoJin Shin, +8251-240-7472; +8251-240-7473, hojinja@hanmail.net

    HoJin Shin

    Recruiting

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

    Seocho, Seoul, 6591

    Sung-Eun Lee, 82222586058, lee86@catholic.ac.kr

    Sung-Eun Lee

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 3080

    Junshik Hong, + 82 1033958656, hongjblood@snu.ac.kr

    Junshik Hong

    Recruiting

  • Severance Hospital

    Seoul, Seoul Teugbyeolsi, 3722

    June-Won Cheong, +82 222285810, jwcheong70@yuhs.ac

    June-Won Cheong

    Recruiting

Other trials in South Korea

Israel3 sites, 3 recruiting

  • Rambam Health Care Campus

    Haifa, 3109601

    Noa Lavi, +972 4 777 3520, n_lavi@rambam.health.gov.il

    Noa Lavi

    Recruiting

  • Carmel Medical Center

    Haifa, 3436212

    Elena Mishchenko, 972 54 4654625, elenahi@clalit.org.il

    Elena Mishchenko

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Tel Aviv, 6423906

    Ilya Kirgner, 97236973473, ilyak@tlvmc.gov.il

    Ilya Kirgner

    Recruiting

Other trials in Israel

Poland3 sites, 3 recruiting

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954

    Krzysztof Giannopoulos, +48814541226; +48814541219;, krzysztof.giannopoulos@umlub.pl

    Krzysztof Giannopoulos

    Recruiting

  • AIDPORT

    Skórzewo, 30 60-185

    Michał Kwiatek, + 48 793 602 210, michal.kwiatek@aidport.pl

    Michał Kwiatek

    Recruiting

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

    Torun, 87-100

    Dominik Charaniuk, 48608654777, d.chraniuk@naszlekarz.pl

    Dominik Charaniuk

    Recruiting

Other trials in Poland

Romania3 sites, 3 recruiting

  • Coltea - Spital Clinic

    Bucharest, 30167

    Gabriela Borsaru, 744150652, gabriex2001@yahoo.it

    Gabriela Borsaru

    Recruiting

  • Spitalul Filantropia - Craiova

    Craiova, 200143

    Luminita Ocroteala, +40 251-307-530, diaconu_luminita@yahoo.com

    Luminita Ocroteala

    Recruiting

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

    Catalin Doru Danaila, 40722565781, c_danaila@yahoo.com

    Catalin Doru Danaila

    Recruiting

Other trials in Romania

Taiwan3 sites, 3 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Hui Hao Hsiao, huhuhs@kmu.edu.tw

    Hui Hao Hsiao

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Hsin-An Hou, 886972653089 ext. #266678, hsinanhou@ntu.edu.tw

    Hsin-An Hou

    Recruiting

  • Taoyuan Chang Gung Memorial Hospital

    Taoyuan, 333

    Hung Chang, "+886 0975-368-107, horng@cgmh.org.tw

    Hung Chang

    Recruiting

Other trials in Taiwan

Belgium2 sites, 2 recruiting

  • UZ Gent

    Ghent, 9000

    Dominiek Mazure, +32 9 332 21 25, dominiek.mazure@uzgent.be

    Dominiek Mazure

    Recruiting

  • UZ Leuven - Campus Gasthuisberg

    Leuven, 3000

    Timothy Devos, +32 (0) 16 346880, timothy.devos@uzleuven.be

    Timothy Devos

    Recruiting

Other trials in Belgium

Germany2 sites, 2 recruiting

  • Marien Hospital Düsseldorf

    Düsseldorf, 40479

    +49 (0)211 / 4400 2501, Stefanie.Groepper@vkkd-kliniken.de

    Stefanie Groepper

    Recruiting

  • University Hospital Jena

    Jena, 7747

    Carl Crodel, +49 3641 9324236, Carl.Crodel@med.uni-jena.de

    Carl Crodel

    Recruiting

Other trials in Germany

Canada1 site, 1 recruiting

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Jonathan How, jonathan.b.how@mcgill.ca

    Jonathan How

    Recruiting

Other trials in Canada

Czechia1 site, 1 recruiting

  • Fakultní nemocnice Olomouc

    Olomouc, 779 00

    Antonín Hluší, +420 588443296, antonin.hlusi@fnol.cz

    Antonín Hluší

    Recruiting

Other trials in Czechia

Denmark1 site, 1 recruiting

  • Aarhus Universitetshospital

    Aarhus N, Central Jutland, 8200

    Peter Buur van Kooten Niekerk, +45 2388 6732, petevank@rm.dk

    Peter Buur van Kooten Niekerk

    Recruiting

Other trials in Denmark

Hungary1 site, 1 recruiting

  • Semmelweis Egyetem

    Budapest, 1088

    Zsolt Nagy, +36 1-2101500, nagy.zsolt@med.semmelweis-univ.hu

    Zsolt Nagy

    Recruiting

Other trials in Hungary

Netherlands1 site, 1 recruiting

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM

    Aart Beeker, +31 232245811, abeeker@spaarnegasthuis.nl

    Aart Beeker

    Recruiting

Other trials in Netherlands

United Kingdom1 site, 1 recruiting

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, SE1 9RT

    Jennifer O'Sullivan, +4402071884259, jennifer.o'sullivan@gstt.nhs.uk

    Jennifer O'Sullivan

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Selinexor 60 mg, Selinexor 40 mg, Ruxolitinib, Pacritinib, Momelotinib
Keywords
Myelofibrosis, Selinexor, Total Symptom Score, Myelofibrosis Symptom Assessment Form, Spleen Volume Reduction, TSS50, SVR35, JAK2, KPT-330, Pacritinib, Ruxolitinib, Momelotinib, Thrombocytopenia, Abs-TSS
Medical subject headings
Primary Myelofibrosis, Thrombocytopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selinexor 60 mgDrug

    Also called KPT-330

    Participants will receive selinexor 60 mg oral tablets QW.

  • Selinexor 40 mgDrug

    Also called KPT-330

    Participants will receive selinexor 40 mg oral tablets QW.

  • RuxolitinibDrug

    Also called JAKAFI

    Participants will receive ruxolitinib per local package insert.

  • PacritinibDrug

    Also called VONJO

    Participants will receive pacritinib per local package insert. For countries where not approved, 200 mg twice daily is the starting dose.

  • MomelotinibDrug

    Also called OJJAARA

    Participants will receive momelotinib per local package insert.

Study groups in NCT05980806
Study groupRoleWhat they receive
Selinexor 60 mg (Arm 1)ExperimentalParticipants 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.
Receives: Drug: Selinexor 60 mg; Drug: Ruxolitinib; Drug: Pacritinib; Drug: Momelotinib
Selinexor 40 mg (Arm 2)ExperimentalParticipants 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.
Receives: Drug: Selinexor 40 mg; Drug: Ruxolitinib; Drug: Pacritinib; Drug: Momelotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants with Spleen Volume Reduction ≥35% (SVR35) at Week 24

    Measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan by Investigator assessment.

    Measured: At Week 24

Secondary outcomes (2)

  1. Absolute Mean Change in Total Symptom Score (Abs-TSS) from baseline to Week 24

    Measured by the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.

    Measured: At Baseline and Week 24

  2. Incidence and severity of TEAEs, including TRAEs and SAEs

    Measured by the NCI CTCAE Grading Scale, v. 5, as assessed and graded by the Investigator

    Measured: From Baseline to EoS (approximately 48 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start22 Apr 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05980806
Sponsor's protocol ID
XPORT-MF-044
Acronym
SENTRY-2
Status last verified
Feb 2026
First submitted
24 Jul 2023
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor 60 mg, Selinexor 40 mg and Ruxolitinib in people with Myelofibrosis and Moderate Thrombocytopenia, run by Karyopharm Therapeutics Inc at 70 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in Italy, France, Spain, United States, Bulgaria and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karyopharm Medical Information ((888) 209-9326, clinicaltrials@karyopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants with Spleen Volume Reduction ≥35% (SVR35) at Week 24 (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05980806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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