- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04562389
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis (SENTRY)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Bankstown, New South Wales, Australia, 2200
- Bankstown-Lidcombe Hospital
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Campbelltown, New South Wales, Australia, 2560
- Campbelltown Hospital
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Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Icon Cancer Centre - Wesley
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- One Clinical Research
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Antwerp, Belgium, 2060
- ZNA Stuivenberg
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Antwerp, Belgium, 2030
- ZNA Stuivenberg - Satelite
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Flemish Brabant
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Leuven, Flemish Brabant, Belgium, 3000
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgium, 9000
- Universitair Ziekenhuis Gent
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West-Vlaanderen
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Bruges, West-Vlaanderen, Belgium, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
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Plovdiv, Bulgaria, 4002
- University Multiprofile Hospital for Active Treatment Sveti George - Base 1
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Sofia, Bulgaria, 1431
- University Multiprofile Hospital for Active Treatment Aleksandrovska
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Sofia, Bulgaria, 1431
- University Multiprofile Hospital for Active Treatment St. Ivan Rilski
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Sofia, Bulgaria, 1797
- Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
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Stara Zagora, Bulgaria, 6003
- University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich
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Alberta
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Edmonton, Alberta, Canada, T6G 2G3
- University of Alberta Hospital
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Ontario
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Oshawa, Ontario, Canada, L1G 2B9
- Lakeridge Health
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Research Institute of the McGill University Health Centre
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Hradec Králové, Czechia, 500 05
- Fakultní Nemocnice Hradec Králové
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Olomouc, Czechia, 779 00
- Fakultní Nemocnice Olomouc
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Prague
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Prague, Prague, Czechia, 128 08
- Vseobecna Fakultni Nemocnice v Praze
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Central Jutland
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Aarhus N, Central Jutland, Denmark, 8200
- Aarhus Universitetshospital
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North Denmark
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Aalborg, North Denmark, Denmark, 9000
- Tang Severinsen, Marianne
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Paris, France, 75010
- Hôpital Saint-Louis
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Aquitaine
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Bordeaux, Aquitaine, France, 33000
- Institut Bergonié
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Aubergne
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Clermont-Ferrand, Aubergne, France, 63003
- Centre Hospitalier Universitaire Estaing
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Auvergne-Rhône-Alpes
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Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
- Centre Hospitalier Lyon-Sud
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Brittany Region
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Brest, Brittany Region, France, 29200
- Hôpital Morvan
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Gard
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Nîmes, Gard, France, 30029
- Chu De Nîmes - Institut De Cancérologie Du Gard
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Grand Est
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Mulhouse, Grand Est, France, 68100
- Hôpital Emile Muller
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Hauts-de-France
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Lille, Hauts-de-France, France, 59037
- Hôpital Huriez
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Indre-et-Loire
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Tours, Indre-et-Loire, France, 37044
- Hôpital Bretonneau
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PACA
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Nice, PACA, France, 06202
- Hôpital l'Archet - CHU Nice
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Pays de la Loire Region
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Angers, Pays de la Loire Region, France, 49 933
- Centre Hospitalier Universitaire d'Angers
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Saint-Priest-en-Jarez, Pays de la Loire Region, France, 42271
- Centre Hospitalier Universitaire de Saint-Étienne
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Île-de-France Region
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Paris, Île-de-France Region, France, 75014
- Hôpital Cochin
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Paris, Île-de-France Region, France, 75013
- Hôpital Universitaire Pitié Salpêtrière
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Baden-Wurttemberg
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Mutlangen, Baden-Wurttemberg, Germany, 73557
- Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Germany, 40479
- Marien Hospital Düsseldorf
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Germany, 6120
- Universitätsklinikum Halle
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Germany, 24116
- Städtisches Krankenhaus Kiel
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Thuringia
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Jena, Thuringia, Germany, 7747
- Universitätsklinikum Jena
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Attica
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Athens, Attica, Greece, 124 62
- University General Hospital Attikon
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Athens, Attica, Greece, 115 27
- Laiko General Hospital of Athens
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Athens, Attica, Greece, 115 28
- General Hospital of Athens "Alexandra"
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Central Macedonia
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Thessaloniki, Central Macedonia, Greece, 570 10
- General Hospital of Thessaloniki George Papanikolaou
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Thessaly
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Ioánnina, Thessaly, Greece, 455 00
- University General Hospital of Ioannina
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Larissa, Thessaly, Greece, 41110
- University General Hospital of Larissa, Hematology Department
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Budapest, Hungary, 1088
- Semmelweis Egyetem
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Győr-Moson-Sopron
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Győr, Győr-Moson-Sopron, Hungary, 9023
- Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center
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Central District
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Be’er Ya‘aqov, Central District, Israel, 7030000
- Shamir Medical Center
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Ramat Gan, Central District, Israel, 5265601
- The Chaim Sheba Medical Center
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Haifa District
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Haifa, Haifa District, Israel, 3109601
- Rambam Health Care Campus
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Haifa, Haifa District, Israel, 3436212
- Carmel Medical Center
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Jerusalem
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Jerusalem, Jerusalem, Israel, 9112001
- Hadassah University Hospital Ein Kerem
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Jerusalem, Jerusalem, Israel, 9112001
- Hadassah University Hospital Mount Scopus
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Northern District
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Afula, Northern District, Israel, 1834111
- Emek Medical Center
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Nahariya, Northern District, Israel, 2210001
- Galilee Medical Center
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Bologna, Italy, 40138
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
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Florence, Italy, 50134
- Azienda Ospedaliero - Universitaria Careggi
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Pavia, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo
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Roma, Italy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Torino, Italy, 10128
- Azienda Ospedaliera Ordine Mauriziano di Torino
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Verona, Italy, 37134
- Centro Ricerche Cliniche di Verona
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Catania
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Catania, Catania, Italy, 95123
- Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico
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Forli-Cesena
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Meldola, Forli-Cesena, Italy, 47014
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
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Genoa
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Genova, Genoa, Italy, 16132
- IRCCS Ospedale Policlinico San Martino
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Milan
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Milan, Milan, Italy, 20122
- Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
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Milan, Milan, Italy, 20141
- Istituto Europeo di Oncologia
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Milan, Milan, Italy, 20162
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Monza and Brianza
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Monza, Monza and Brianza, Italy, 20900
- Fondazione IRCCS San Gerardo dei Tintori
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Novara
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Novara, Novara, Italy, 28100
- Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
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Potenza
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Rionero in Vulture, Potenza, Italy, 85028
- IRCCS Centro di Riferimento Oncologico di Basilicata
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Rome
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Roma, Rome, Italy, 00161
- Umberto I - Policlinico di Roma
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Turin
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Torino, Turin, Italy, 10126
- Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
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Viterbo
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Rome, Viterbo, Italy, 00128
- Università Campus Bio-Medico di Roma
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Groningen, Netherlands, 9713 GZ
- Universitair Medisch Centrum Groningen
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North Holland
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Hoofddorp, North Holland, Netherlands, 2134 TM
- Spaarne Gasthuis - Hoofddorp
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Greater Poland Voivodeship
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Skórzewo, Greater Poland Voivodeship, Poland, 60-185
- AIDPORT
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Kuyavian-Pomeranian Voivodeship
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Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
- Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Toruń
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Poland, 53-439
- Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Poland, 20-093
- Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
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Podkarpackie Voivodeship
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Brzozów, Podkarpackie Voivodeship, Poland, 36-200
- Szpital Specjalistyczny w Brzozowie - Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Poland, 80-952
- Uniwersyteckie Centrum Kliniczne w Gdańsku
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Poland, 40-519
- Pratia Onkologia Katowice
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Wałbrzych, Silesian Voivodeship, Poland, 58-309
- Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
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Bucharest, Romania, 20125
- Spitalul Clinic Colentina
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Bucharest, Romania, 020125
- Coltea - Spital Clinic
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Iași, Romania, 700483
- Institutul Regional De Oncologie Iasi
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Cluj
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Cluj-Napoca, Cluj, Romania, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta
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Dolj
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Craiova, Dolj, Romania, 200136
- Spitalul Filantropia - Craiova
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Mureș County
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Târgu Mureş, Mureș County, Romania, 540136
- Spitalul Clinic Judetean De Urgenta Târgu Mureș
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Daegu, South Korea, 41944
- Kyungpook National University Hospital
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Seoul, South Korea, 03080
- Seoul National University Hospital
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Seoul, South Korea, 03722
- Severance Hospital
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Seoul, South Korea, 6351
- Samsung Medical Center
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Seoul, South Korea, 06591
- The Catholic University of Korea - Seoul St. Mary's Hospital
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Gwang'Yeogsi
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Busan, Gwang'Yeogsi, South Korea, 49241
- Pusan National University Hospital
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Gyeonggido
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Seongnam-si, Gyeonggido, South Korea, 13605
- Seoul National University Bundang Hospital
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Jeollanam-do
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Hwasun, Jeollanam-do, South Korea, 58128
- Chonnam National University Hwasun Hospital
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Badalona, Spain, 08916
- Institut Català d'Oncologia Badalona
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Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebrón
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Girona, Spain, 17007
- Institut Català d'Oncologia Girona (ICO Girona)
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Las Palmas de Gran Canaria, Spain, 35010
- Hospital Universitario de Gran Canaria Doctor Negrin
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Lugo, Spain, 27003
- Hospital Universitario Lucus Augusti
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañón
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Madrid, Spain, 28034
- Hospital Universitario Ramón y Cajal
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Murcia, Spain, 30120
- Hospital Clínico Universitario Virgen de la Arrixaca
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Málaga, Spain, 29010
- Hospital Universitario Virgen de la Victoria
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Salamanca, Spain, 37007
- Complejo Asistencial Universitario de Salamanca - Hospital Clínico
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Valencia, Spain, 46010
- Hospital Clínico Universitario de Valencia
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Cáceres
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Cáceres, Cáceres, Spain, 10003
- Hospital San Pedro de Alcantara
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Principality of Asturias
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Oviedo, Principality of Asturias, Spain, 33011
- Hospital Universitario Central de Asturias
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Zaragoza
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Zaragoza, Zaragoza, Spain, 50012
- Hospital de Día Quirónsalud Zaragoza
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Kaohsiung City, Taiwan, 83301
- Chang Gung Memorial Hospital - Kaohsiung Branch
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Kaohsiung City, Taiwan, 80756
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Taipei, Taiwan, 10048
- National Taiwan University Hospital
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Taoyuan, Taiwan, 33305
- Chang Gung Memorial Hospital - Linkou Branch
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Taichung
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Taichung, Taichung, Taiwan, 40447
- China Medical University Hospital
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Boston, United Kingdom, PE21 9QS
- United Lincolnshire Hospitals NHS Trust
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Boston, United Kingdom, PE21 9QS
- United Lincolnshire Hospitals NHS Trust-Satellite Site
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Liverpool, United Kingdom, LZ 8XP
- The Clatterbridge Cancer Centre NHS Foundation Trust
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London, United Kingdom, W12 0HS
- Imperial College Healthcare NHS Trust
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Newcastle upon Tyne, United Kingdom, NE7 7DN
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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England
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London, England, United Kingdom, SE1 9RT
- Guy's and St Thomas' NHS Foundation Trust
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Oxford, England, United Kingdom, OX3 7LE
- Oxford University Hospitals NHS Foundation Trust
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Alabama
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Birmingham, Alabama, United States, 35294
- UAB Division of Hematology/Oncology
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California
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Beverly Hills, California, United States, 90210
- UCLA - Satellite Site
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Duarte, California, United States, 91010
- City of Hope
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Encino, California, United States, 93003
- UCLA - Satellite Site
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Irvine, California, United States, 92618
- City of Hope - Irvine Lennar - Satellite
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Los Angles, California, United States, 90095
- UCLA
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Pasadena, California, United States, 91105
- The Oncology Institute of Hope & Innovation
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Colorado
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Aurora, Colorado, United States, 80045
- USOR - Rocky Mountain Cancer Centers - Aurora
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Connecticut
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New Haven, Connecticut, United States, 06511
- Smilow Cancer Hospital - New Haven
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District of Columbia
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Washington D.C., District of Columbia, United States, 20007
- Georgetown Lombardi Comprehensive Center
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Kentucky
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Louisville, Kentucky, United States, 40207
- Norton Cancer Institute - Saint Matthews
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Maryland
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Annapolis, Maryland, United States, 21401
- Maryland Oncology Hematology-Satellite
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Baltimore, Maryland, United States, 21205
- The Sidney Kimmel Comprehensive Cancer Center
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Brandywine, Maryland, United States, 21004
- Maryland Oncology Hematology-Satellite
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Columbia, Maryland, United States, 21044
- Maryland Oncology Hematology
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Rockville, Maryland, United States, 20850
- Maryland Oncology Hematology-Satellite
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Silver Spring, Maryland, United States, 20904
- Maryland Oncology Hematology-Satellite
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Michigan
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Grand Rapids, Michigan, United States, 49546
- The Cancer & Hematology Centers -Satellite Site
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Norton Shores, Michigan, United States, 49444
- The Cancer & Hematology Centers of Muskegon
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New Jersey
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Hackensack, New Jersey, United States, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10029
- Mount Sinai Health System
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke Cancer Institue
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Ohio
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Cincinnati, Ohio, United States, 45242
- USOR - Oncology Hematology Care - Kenwood
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Columbus, Ohio, United States, 43214
- OhioHealth
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt Ingram Cancer Center
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Texas
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Dallas, Texas, United States, 75246
- Texas Oncology
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Virginia
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Gainesville, Virginia, United States, 20155
- USOR - Virginia Cancer Specialists - Gainesville Office
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Richmond, Virginia, United States, 23298
- VCU Massey Cancer Center
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Virginia Beach, Virginia, United States, 23456
- USOR - Virginia Oncology Associates - Virginia Beach
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Center - SCAA South Lake Union
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West Virginia
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Wheeling, West Virginia, United States, 26003
- West Virginia University Cancer Institute, Wheeling Hospital
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin - Madison
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BID
Participants 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. |
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Other Names:
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Other Names:
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID. |
|
Experimental: Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BID
Participants 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. |
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Other Names:
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Other Names:
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID. |
|
Experimental: Phase 1b: Selinexor and Ruxolitinib BID
Participants 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. |
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Other Names:
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Other Names:
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID. |
|
Experimental: Phase 3: Selinexor 60 mg + Ruxolitinib BID
Participants 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. |
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Other Names:
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Other Names:
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID. |
|
Active Comparator: Phase 3: Placebo + Ruxolitinib BID
Participants 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. |
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID. Participants will receive a matching placebo of selinexor oral tablets QW |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Phase 1: Maximum Tolerated Dose (MTD)
Time Frame: Approximately within the first cycle (28 days) of therapy
|
Approximately within the first cycle (28 days) of therapy
|
|
Phase 1: Recommended Phase 2 Dose (RP2D)
Time Frame: Approximately within the first cycle (28 days) of therapy
|
Approximately within the first cycle (28 days) of therapy
|
|
Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity
Time Frame: From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)
|
From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)
|
|
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
|
At Week 24
|
|
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
Time Frame: At Week 24
|
At Week 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Phase 3: Progression-free survival (PFS)
Time Frame: Time from randomization until disease progression or death, whichever occurs first (approximately 48 months)
|
Time from randomization until disease progression or death, whichever occurs first (approximately 48 months)
|
|
Phase 3: Overall survival (OS)
Time Frame: From Baseline up to EoS (approximately 48 months)
|
From Baseline up to EoS (approximately 48 months)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XPORT-MF-034
- 2020-003883-19 (EudraCT Number)
- 2023-506139-13-00 (Ctis)
- 2023 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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