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
3 other identifiers
interventional
353
20 countries
166
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2021
Longer than P75 for phase_3
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2020
CompletedFirst Posted
Study publicly available on registry
September 24, 2020
CompletedStudy Start
First participant enrolled
March 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
ExpectedApril 9, 2026
April 1, 2026
5 years
September 14, 2020
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
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
At Week 24
Phase 1: Maximum Tolerated Dose (MTD)
Approximately within the first cycle (28 days) of therapy
Phase 1: Recommended Phase 2 Dose (RP2D)
Approximately within the first cycle (28 days) of therapy
Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity
From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)
Secondary Outcomes (2)
Phase 3: Overall survival (OS)
From Baseline up to EoS (approximately 48 months)
Phase 3: Progression-free survival (PFS)
Time from randomization until disease progression or death, whichever occurs first (approximately 48 months)
Study Arms (5)
Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BID
EXPERIMENTALParticipants 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.
Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BID
EXPERIMENTALParticipants 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.
Phase 1b: Selinexor and Ruxolitinib BID
EXPERIMENTALParticipants 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.
Phase 3: Selinexor 60 mg + Ruxolitinib BID
EXPERIMENTALParticipants 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.
Phase 3: Placebo + Ruxolitinib BID
ACTIVE 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.
Interventions
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Participants will receive a matching placebo of selinexor oral tablets QW
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (166)
UAB Division of Hematology/Oncology
Birmingham, Alabama, 35294, United States
UCLA - Satellite Site
Beverly Hills, California, 90210, United States
City of Hope
Duarte, California, 91010, United States
UCLA - Satellite Site
Encino, California, 93003, United States
City of Hope - Irvine Lennar - Satellite
Irvine, California, 92618, United States
UCLA
Los Angles, California, 90095, United States
The Oncology Institute of Hope & Innovation
Pasadena, California, 91105, United States
USOR - Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80045, United States
Smilow Cancer Hospital - New Haven
New Haven, Connecticut, 06511, United States
Georgetown Lombardi Comprehensive Center
Washington D.C., District of Columbia, 20007, United States
Norton Cancer Institute - Saint Matthews
Louisville, Kentucky, 40207, United States
Maryland Oncology Hematology-Satellite
Annapolis, Maryland, 21401, United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21205, United States
Maryland Oncology Hematology-Satellite
Brandywine, Maryland, 21004, United States
Maryland Oncology Hematology
Columbia, Maryland, 21044, United States
Maryland Oncology Hematology-Satellite
Rockville, Maryland, 20850, United States
Maryland Oncology Hematology-Satellite
Silver Spring, Maryland, 20904, United States
The Cancer & Hematology Centers -Satellite Site
Grand Rapids, Michigan, 49546, United States
The Cancer & Hematology Centers of Muskegon
Norton Shores, Michigan, 49444, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Mount Sinai Health System
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke Cancer Institue
Durham, North Carolina, 27705, United States
USOR - Oncology Hematology Care - Kenwood
Cincinnati, Ohio, 45242, United States
Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210, United States
OhioHealth
Columbus, Ohio, 43214, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Texas Oncology
Dallas, Texas, 75246, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
USOR - Virginia Cancer Specialists - Gainesville Office
Gainesville, Virginia, 20155, United States
VCU Massey Cancer Center
Richmond, Virginia, 23298, United States
USOR - Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia, 23456, United States
Fred Hutchinson Cancer Center - SCAA South Lake Union
Seattle, Washington, 98109, United States
West Virginia University Cancer Institute, Wheeling Hospital
Wheeling, West Virginia, 26003, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792, United States
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200, Australia
Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Icon Cancer Centre - Wesley
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
One Clinical Research
Nedlands, Western Australia, 6009, Australia
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant, 3000, Belgium
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Bruges, West-Vlaanderen, 8000, Belgium
ZNA Stuivenberg - Satelite
Antwerp, 2030, Belgium
ZNA Stuivenberg
Antwerp, 2060, Belgium
University Multiprofile Hospital for Active Treatment Sveti George - Base 1
Plovdiv, 4002, Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski
Sofia, 1431, Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
Sofia, 1797, Bulgaria
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich
Stara Zagora, 6003, Bulgaria
University of Alberta Hospital
Edmonton, Alberta, T6G 2G3, Canada
Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Vseobecna Fakultni Nemocnice v Praze
Prague, Prague, 128 08, Czechia
Fakultní Nemocnice Hradec Králové
Hradec Králové, 500 05, Czechia
Fakultní Nemocnice Olomouc
Olomouc, 779 00, Czechia
Aarhus Universitetshospital
Aarhus N, Central Jutland, 8200, Denmark
Tang Severinsen, Marianne
Aalborg, North Denmark, 9000, Denmark
Institut Bergonié
Bordeaux, Aquitaine, 33000, France
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, Aubergne, 63003, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
Hôpital Morvan
Brest, Brittany Region, 29200, France
Chu De Nîmes - Institut De Cancérologie Du Gard
Nîmes, Gard, 30029, France
Hôpital Emile Muller
Mulhouse, Grand Est, 68100, France
Hôpital Huriez
Lille, Hauts-de-France, 59037, France
Hôpital Bretonneau
Tours, Indre-et-Loire, 37044, France
Hôpital l'Archet - CHU Nice
Nice, PACA, 06202, France
Centre Hospitalier Universitaire d'Angers
Angers, Pays de la Loire Region, 49 933, France
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Priest-en-Jarez, Pays de la Loire Region, 42271, France
Hôpital Saint-Louis
Paris, 75010, France
Hôpital Universitaire Pitié Salpêtrière
Paris, Île-de-France Region, 75013, France
Hôpital Cochin
Paris, Île-de-France Region, 75014, France
Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
Mutlangen, Baden-Wurttemberg, 73557, Germany
Marien Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40479, Germany
Universitätsklinikum Halle
Halle, Saxony-Anhalt, 6120, Germany
Städtisches Krankenhaus Kiel
Kiel, Schleswig-Holstein, 24116, Germany
Universitätsklinikum Jena
Jena, Thuringia, 7747, Germany
Laiko General Hospital of Athens
Athens, Attica, 115 27, Greece
General Hospital of Athens "Alexandra"
Athens, Attica, 115 28, Greece
University General Hospital Attikon
Athens, Attica, 124 62, Greece
General Hospital of Thessaloniki George Papanikolaou
Thessaloniki, Central Macedonia, 570 10, Greece
University General Hospital of Ioannina
Ioánnina, Thessaly, 455 00, Greece
University General Hospital of Larissa, Hematology Department
Larissa, Thessaly, 41110, Greece
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, Győr-Moson-Sopron, 9023, Hungary
Semmelweis Egyetem
Budapest, 1088, Hungary
Shamir Medical Center (Assaf Harofeh)
Be’er Ya‘aqov, Central District, 7030000, Israel
The Chaim Sheba Medical Center
Ramat Gan, Central District, 5265601, Israel
Rambam Health Care Campus
Haifa, Haifa District, 3109601, Israel
Carmel Medical Center
Haifa, Haifa District, 3436212, Israel
Hadassah University Hospital - Mount Scopus - Satellite Site
Jerusalem, Jerusalem, 9112001, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, Jerusalem, 9112001, Israel
Emek Medical Center
Afula, Northern District, 1834111, Israel
Western Galilee Hospital-Nahariya
Nahariya, Northern District, 2210001, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico
Catania, Catania, 95123, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forli-Cesena, 47014, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Genoa, 16132, Italy
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
Milan, Milan, 20122, Italy
Istituto Europeo di Oncologia
Milan, Milan, 20141, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Milan, 20162, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza and Brianza, 20900, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Novara, 28100, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata
Rionero in Vulture, Potenza, 85028, Italy
Umberto I - Policlinico di Roma
Roma, Rome, 00161, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Turin, 10126, Italy
Università Campus Bio-Medico di Roma
Rome, Viterbo, 00128, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna, 40138, Italy
Azienda Ospedaliero - Universitaria Careggi
Florence, 50134, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128, Italy
Centro Ricerche Cliniche di Verona
Verona, 37134, Italy
Spaarne Gasthuis - Hoofddorp
Hoofddorp, North Holland, 2134 TM, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
AIDPORT
Skórzewo, Greater Poland Voivodeship, 60-185, Poland
Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Toruń
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
Wroclaw, Lower Silesian Voivodeship, 53-439, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, Lublin Voivodeship, 20-093, Poland
Szpital Specjalistyczny w Brzozowie - Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów, Podkarpackie Voivodeship, 36-200, Poland
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, 40-519, Poland
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
Wałbrzych, Silesian Voivodeship, 58-309, Poland
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj, 400015, Romania
Spitalul Filantropia - Craiova
Craiova, Dolj, 200136, Romania
Spitalul Clinic Judetean De Urgenta Târgu Mureș
Târgu Mureş, Mureș County, 540136, Romania
Coltea - Spital Clinic
Bucharest, 020125, Romania
Spitalul Clinic Colentina
Bucharest, 20125, Romania
Institutul Regional De Oncologie Iasi
Iași, 700483, Romania
Pusan National University Hospital
Busan, Gwang'Yeogsi, 49241, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13605, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Hospital San Pedro de Alcantara
Cáceres, Cáceres, 10003, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital de Día Quirónsalud Zaragoza
Zaragoza, Zaragoza, 50012, Spain
Institut Català d'Oncologia Badalona
Badalona, 08916, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Institut Català d'Oncologia Girona (ICO Girona)
Girona, 17007, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, 35010, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, 37007, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
China Medical University Hospital
Taichung, Taichung, 40447, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, 83301, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan District, 33305, Taiwan
Guy's and St Thomas' NHS Foundation Trust
London, England, SE1 9RT, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, England, OX3 7LE, United Kingdom
United Lincolnshire Hospitals NHS Trust-Satellite Site
Boston, PE21 9QS, United Kingdom
United Lincolnshire Hospitals NHS Trust
Boston, PE21 9QS, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, LZ 8XP, United Kingdom
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (1)
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.
PMID: 39911057DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2020
First Posted
September 24, 2020
Study Start
March 11, 2021
Primary Completion
February 20, 2026
Study Completion (Estimated)
March 1, 2028
Last Updated
April 9, 2026
Record last verified: 2026-04