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MyelofibrosisPhase 3SENTRYNCT04562389

Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

A Phase 3 study testing Selinexor and Ruxolitinib in people with Myelofibrosis, run by Karyopharm Therapeutics Inc at 166 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelofibrosis
What is being tested?
Selinexor and Ruxolitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
353 participants
Where
166 sitesin 20 countries
Study dates
11 Mar 2021to Mar 2028
Phase
Phase 3
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

  • 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.

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.

Trial locations and contacts

166 sites in 20 countries.

166 sites in 20 countries

United States36 sites

  • Maryland Oncology Hematology-Satellite

    Annapolis, Maryland, 21401

  • USOR - Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80045

  • The Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21205

  • UCLA - Satellite Site

    Beverly Hills, California, 90210

  • UAB Division of Hematology/Oncology

    Birmingham, Alabama, 35294

  • Maryland Oncology Hematology-Satellite

    Brandywine, Maryland, 21004

  • USOR - Oncology Hematology Care - Kenwood

    Cincinnati, Ohio, 45242

  • Maryland Oncology Hematology

    Columbia, Maryland, 21044

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

    Columbus, Ohio, 43210

  • OhioHealth

    Columbus, Ohio, 43214

  • Texas Oncology

    Dallas, Texas, 75246

  • City of Hope

    Duarte, California, 91010

  • Duke Cancer Institue

    Durham, North Carolina, 27705

  • UCLA - Satellite Site

    Encino, California, 93003

  • USOR - Virginia Cancer Specialists - Gainesville Office

    Gainesville, Virginia, 20155

  • The Cancer & Hematology Centers -Satellite Site

    Grand Rapids, Michigan, 49546

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • City of Hope - Irvine Lennar - Satellite

    Irvine, California, 92618

  • UCLA

    Los Angles, California, 90095

  • Norton Cancer Institute - Saint Matthews

    Louisville, Kentucky, 40207

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Smilow Cancer Hospital - New Haven

    New Haven, Connecticut, 06511

  • Mount Sinai Health System

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • The Cancer & Hematology Centers of Muskegon

    Norton Shores, Michigan, 49444

  • The Oncology Institute of Hope & Innovation

    Pasadena, California, 91105

  • VCU Massey Cancer Center

    Richmond, Virginia, 23298

  • Maryland Oncology Hematology-Satellite

    Rockville, Maryland, 20850

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Fred Hutchinson Cancer Center - SCAA South Lake Union

    Seattle, Washington, 98109

  • Maryland Oncology Hematology-Satellite

    Silver Spring, Maryland, 20904

  • USOR - Virginia Oncology Associates - Virginia Beach

    Virginia Beach, Virginia, 23456

  • Georgetown Lombardi Comprehensive Center

    Washington D.C., District of Columbia, 20007

  • West Virginia University Cancer Institute, Wheeling Hospital

    Wheeling, West Virginia, 26003

Other trials in United States

Italy18 sites

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

    Bologna, 40138

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

    Catania, Catania, 95123

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, 50134

  • IRCCS Ospedale Policlinico San Martino

    Genova, Genoa, 16132

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

    Meldola, Forli-Cesena, 47014

  • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

    Milan, Milan, 20122

  • Istituto Europeo di Oncologia

    Milan, Milan, 20141

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, Milan, 20162

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Monza and Brianza, 20900

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    Novara, Novara, 28100

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • IRCCS Centro di Riferimento Oncologico di Basilicata

    Rionero in Vulture, Potenza, 85028

  • Umberto I - Policlinico di Roma

    Roma, Rome, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • Università Campus Bio-Medico di Roma

    Rome, Viterbo, 00128

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

    Torino, Turin, 10126

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 10128

  • Centro Ricerche Cliniche di Verona

    Verona, 37134

Other trials in Italy

Spain16 sites

  • Institut Català d'Oncologia Badalona

    Badalona, 08916

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital San Pedro de Alcantara

    Cáceres, Cáceres, 10003

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

    Girona, 17007

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, 35010

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico

    Salamanca, 37007

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital de Día Quirónsalud Zaragoza

    Zaragoza, Zaragoza, 50012

Other trials in Spain

France14 sites

  • Centre Hospitalier Universitaire d'Angers

    Angers, Pays de la Loire Region, 49 933

  • Institut Bergonié

    Bordeaux, Aquitaine, 33000

  • Hôpital Morvan

    Brest, Brittany Region, 29200

  • Centre Hospitalier Universitaire Estaing

    Clermont-Ferrand, Aubergne, 63003

  • Hôpital Huriez

    Lille, Hauts-de-France, 59037

  • Hôpital Emile Muller

    Mulhouse, Grand Est, 68100

  • Hôpital l'Archet - CHU Nice

    Nice, PACA, 06202

  • Chu De Nîmes - Institut De Cancérologie Du Gard

    Nîmes, Gard, 30029

  • Hôpital Saint-Louis

    Paris, 75010

  • Hôpital Universitaire Pitié Salpêtrière

    Paris, Île-de-France Region, 75013

  • Hôpital Cochin

    Paris, Île-de-France Region, 75014

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Centre Hospitalier Universitaire de Saint-Étienne

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

  • Hôpital Bretonneau

    Tours, Indre-et-Loire, 37044

Other trials in France

Israel9 sites

  • Emek Medical Center

    Afula, Northern District, 1834111

  • Shamir Medical Center

    Be’er Ya‘aqov, Central District, 7030000

  • Rambam Health Care Campus

    Haifa, Haifa District, 3109601

  • Carmel Medical Center

    Haifa, Haifa District, 3436212

  • Hadassah University Hospital Ein Kerem

    Jerusalem, Jerusalem, 9112001

  • Hadassah University Hospital Mount Scopus

    Jerusalem, Jerusalem, 9112001

  • Galilee Medical Center

    Nahariya, Northern District, 2210001

  • The Chaim Sheba Medical Center

    Ramat Gan, Central District, 5265601

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Poland8 sites

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

    Brzozów, Podkarpackie Voivodeship, 36-200

  • Uniwersyteckie Centrum Kliniczne w Gdańsku

    Gdansk, Pomeranian Voivodeship, 80-952

  • Pratia Onkologia Katowice

    Katowice, Silesian Voivodeship, 40-519

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, Lublin Voivodeship, 20-093

  • AIDPORT

    Skórzewo, Greater Poland Voivodeship, 60-185

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

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu

    Wałbrzych, Silesian Voivodeship, 58-309

  • Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

    Wroclaw, Lower Silesian Voivodeship, 53-439

Other trials in Poland

South Korea8 sites

  • Pusan National University Hospital

    Busan, Gwang'Yeogsi, 49241

  • Kyungpook National University Hospital

    Daegu, 41944

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13605

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

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

    Seoul, 06591

  • Samsung Medical Center

    Seoul, 6351

Other trials in South Korea

United Kingdom7 sites

  • United Lincolnshire Hospitals NHS Trust-Satellite Site

    Boston, PE21 9QS

  • United Lincolnshire Hospitals NHS Trust

    Boston, PE21 9QS

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, LZ 8XP

  • Guy's and St Thomas' NHS Foundation Trust

    London, England, SE1 9RT

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE7 7DN

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, England, OX3 7LE

Other trials in United Kingdom

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales, 2200

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • One Clinical Research

    Nedlands, Western Australia, 6009

  • Icon Cancer Centre - Wesley

    South Brisbane, Queensland, 4101

Other trials in Australia

Greece6 sites

  • Laiko General Hospital of Athens

    Athens, Attica, 115 27

  • General Hospital of Athens "Alexandra"

    Athens, Attica, 115 28

  • University General Hospital Attikon

    Athens, Attica, 124 62

  • University General Hospital of Ioannina

    Ioánnina, Thessaly, 455 00

  • University General Hospital of Larissa, Hematology Department

    Larissa, Thessaly, 41110

  • General Hospital of Thessaloniki George Papanikolaou

    Thessaloniki, Central Macedonia, 570 10

Other trials in Greece

Romania6 sites

  • Coltea - Spital Clinic

    Bucharest, 020125

  • Spitalul Clinic Colentina

    Bucharest, 20125

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, Cluj, 400015

  • Spitalul Filantropia - Craiova

    Craiova, Dolj, 200136

  • Institutul Regional De Oncologie Iasi

    Iași, 700483

  • Spitalul Clinic Judetean De Urgenta Târgu Mureș

    Târgu Mureş, Mureș County, 540136

Other trials in Romania

Belgium5 sites

  • ZNA Stuivenberg - Satelite

    Antwerp, 2030

  • ZNA Stuivenberg

    Antwerp, 2060

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

    Bruges, West-Vlaanderen, 8000

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, Flemish Brabant, 3000

Other trials in Belgium

Bulgaria5 sites

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

    Plovdiv, 4002

  • University Multiprofile Hospital for Active Treatment Aleksandrovska

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment St. Ivan Rilski

    Sofia, 1431

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

    Sofia, 1797

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

    Stara Zagora, 6003

Other trials in Bulgaria

Germany5 sites

  • Marien Hospital Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40479

  • Universitätsklinikum Halle

    Halle, Saxony-Anhalt, 6120

  • Universitätsklinikum Jena

    Jena, Thuringia, 7747

  • Städtisches Krankenhaus Kiel

    Kiel, Schleswig-Holstein, 24116

  • Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd

    Mutlangen, Baden-Wurttemberg, 73557

Other trials in Germany

Taiwan5 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10048

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan, 33305

Other trials in Taiwan

Canada3 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2G3

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9

Other trials in Canada

Czechia3 sites

  • Fakultní Nemocnice Hradec Králové

    Hradec Králové, 500 05

  • Fakultní Nemocnice Olomouc

    Olomouc, 779 00

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, Prague, 128 08

Other trials in Czechia

Denmark2 sites

  • Tang Severinsen, Marianne

    Aalborg, North Denmark, 9000

  • Aarhus Universitetshospital

    Aarhus N, Central Jutland, 8200

Other trials in Denmark

Hungary2 sites

  • Semmelweis Egyetem

    Budapest, 1088

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

    Győr, Győr-Moson-Sopron, 9023

Other trials in Hungary

Netherlands2 sites

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Spaarne Gasthuis - Hoofddorp

    Hoofddorp, North Holland, 2134 TM

Other trials in Netherlands

About this study

Official title: 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

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.

Conditions
Myelofibrosis
Being tested
Selinexor, Placebo, Ruxolitinib
Keywords
Myelofibrosis, Selinexor, Ruxolitinib, Janus kinase 2, Myeloproliferative neoplasms
Medical subject headings
Primary Myelofibrosis, Myeloproliferative Disorders

What participants receive

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

  • SelinexorDrug

    Also called KPT-330

    Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.

  • SelinexorDrug

    Also called KPT-330

    Participants will receive a dose of 60 mg selinexor oral tablets QW.

  • PlaceboOther

    Participants will receive a matching placebo of selinexor oral tablets QW

  • RuxolitinibDrug

    Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.

Study groups in NCT04562389
Study groupRoleWhat they receive
Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BIDExperimentalParticipants with MF will receive a dose of 40 milligrams (mg) selinexor oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib twice a day (BID) based on the participants baseline platelet count.
Receives: Drug: Selinexor; Drug: Ruxolitinib
Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BIDExperimentalParticipants with MF will receive a dose of 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Receives: Drug: Selinexor; Drug: Ruxolitinib
Phase 1b: Selinexor and Ruxolitinib BIDExperimentalParticipants with MF will receive a dose of 40 or 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Receives: Drug: Selinexor; Drug: Ruxolitinib
Phase 3: Selinexor 60 mg + Ruxolitinib BIDExperimentalParticipants with MF will receive a fixed starting dose of 60 mg selinexor (RD) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Receives: Drug: Selinexor; Drug: Ruxolitinib
Phase 3: Placebo + Ruxolitinib BIDActive comparatorParticipants with MF will receive a matching placebo of selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Receives: Other: Placebo; Drug: Ruxolitinib

What is being measured

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

  1. Phase 3: Proportion of Participants with Spleen Volume Reduction (SVR) of Greater than or Equal to (>=) 35 Percent (%) (SVR35) at Week 24 Measured by the Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan

    Measured: At Week 24

  2. Phase 3: Absolute mean change in TSS (Abs-TSS) from baseline to Week 24 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0

    Measured: At Week 24

  3. Phase 1: Maximum Tolerated Dose (MTD)

    Measured: Approximately within the first cycle (28 days) of therapy

  4. Phase 1: Recommended Phase 2 Dose (RP2D)

    Measured: Approximately within the first cycle (28 days) of therapy

  5. Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity

    Measured: From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)

Secondary outcomes (2)

  1. Phase 3: Overall survival (OS)

    Measured: From Baseline up to EoS (approximately 48 months)

  2. Phase 3: Progression-free survival (PFS)

    Measured: Time from randomization until disease progression or death, whichever occurs first (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 posted24 Sep 2020
  2. Study start11 Mar 2021
  3. Primary completion20 Feb 2026
  4. Study completionMar 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase 1, open-label, selinexor dose escalation and expansion part (enrollment completed). Phase 3, randomized, double-blind, placebo-controlled part.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04562389
Sponsor's protocol ID
XPORT-MF-034
Other IDs
2020-003883-19, 2023-506139-13-00, 2023
Acronym
SENTRY
Status last verified
Nov 2026
First submitted
14 Sep 2020
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bose P, Ali H, Al-Ali HK, Garcia-Gutierrez V, Grosicki S, Grudeva-Popova Z, Harrison C, Hong J, Hou HA, Kwiatek M, Loschi M, Passamonti F, Patriarca A, Podoltsev N, Rampal R, Tantravahi S, Urian LG, Chai Y, Taverna P, Mark T, Sadiq A, Rangwala R, Vachhani P, Mascarenhas J; SENTRY Trial Investigators. Selinexor Plus Ruxolitinib in Janus Kinase Inhibitor-Naive Myelofibrosis: Phase III SENTRY Trial. J Clin Oncol. 2026 Aug;44(22):2098-2109. doi: 10.1200/JCO-26-01080. Epub 2026 Jun 2.

    PubMed 42227656

  • Ali H, Mohan S, Kishtagari A, Prchal JT, Maher K, Chai Y, Gudi G, Taverna P, Mark T, Tantravahi SK. Selinexor plus ruxolitinib in JAK inhibitor-naive patients with myelofibrosis: a multicenter, open-label, phase 1 study. Blood Adv. 2026 May 26;10(10):3383-3397. doi: 10.1182/bloodadvances.2025018706.

    PubMed 41785311

  • Mascarenhas J, Maher K, Rampal R, Bose P, Podoltsev N, Hong J, Chai Y, Kye S, Method M, Harrison C; SENTRY investigators. Selinexor plus ruxolitinib in JAK inhibitor treatment-naive myelofibrosis: SENTRY Phase 3 study design. Future Oncol. 2025 Mar;21(7):807-813. doi: 10.1080/14796694.2025.2461393. Epub 2025 Feb 6.

    PubMed 39911057

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Selinexor and Ruxolitinib in people with Myelofibrosis, run by Karyopharm Therapeutics Inc at 166 sites in 20 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Italy, Spain, France, Israel and 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 3: Proportion of Participants with Spleen Volume Reduction (SVR) of Greater than or Equal to (>=) 35 Percent (%) (SVR35) at Week 24 Measured by the Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan (time frame: At Week 24). The study lists 5 primary outcomes in all. 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 NCT04562389, which also lists 3 linked publications.

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 4 Nov 2026.

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