En undersøgelse til evaluering af sikkerhed og effektivitet af Selinexor i kombination med Ruxolitinib hos deltagere med myelofibrose (SENTRY)
3. november 2026 opdateret af: Karyopharm Therapeutics Inc
Et fase 1/2-studie til evaluering af sikkerhed og effektivitet af Selinexor, en selektiv hæmmer af nuklear eksport, i kombination med ruxolitinib, i behandlingsnaive patienter med myelofibrose
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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
353
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Bankstown, New South Wales, Australien, 2200
- Bankstown-Lidcombe Hospital
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Campbelltown, New South Wales, Australien, 2560
- Campbelltown Hospital
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Liverpool, New South Wales, Australien, 2170
- Liverpool Hospital
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Queensland
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South Brisbane, Queensland, Australien, 4101
- Icon Cancer Centre - Wesley
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South Australia
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Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital
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Western Australia
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Nedlands, Western Australia, Australien, 6009
- One Clinical Research
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Antwerp, Belgien, 2060
- ZNA Stuivenberg
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Antwerp, Belgien, 2030
- ZNA Stuivenberg - Satelite
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Flemish Brabant
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Leuven, Flemish Brabant, Belgien, 3000
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgien, 9000
- Universitair Ziekenhuis Gent
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West-Vlaanderen
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Bruges, West-Vlaanderen, Belgien, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
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Plovdiv, Bulgarien, 4002
- University Multiprofile Hospital for Active Treatment Sveti George - Base 1
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Sofia, Bulgarien, 1431
- University Multiprofile Hospital for Active Treatment Aleksandrovska
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Sofia, Bulgarien, 1431
- University Multiprofile Hospital for Active Treatment St. Ivan Rilski
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Sofia, Bulgarien, 1797
- Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
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Stara Zagora, Bulgarien, 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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Central Jutland
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Aarhus N, Central Jutland, Danmark, 8200
- Aarhus Universitetshospital
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North Denmark
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Aalborg, North Denmark, Danmark, 9000
- Tang Severinsen, Marianne
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Boston, Det Forenede Kongerige, PE21 9QS
- United Lincolnshire Hospitals NHS Trust
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Boston, Det Forenede Kongerige, PE21 9QS
- United Lincolnshire Hospitals NHS Trust-Satellite Site
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Liverpool, Det Forenede Kongerige, LZ 8XP
- The Clatterbridge Cancer Centre NHS Foundation Trust
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London, Det Forenede Kongerige, W12 0HS
- Imperial College Healthcare NHS Trust
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Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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England
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London, England, Det Forenede Kongerige, SE1 9RT
- Guy's and St Thomas' NHS Foundation Trust
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Oxford, England, Det Forenede Kongerige, OX3 7LE
- Oxford University Hospitals NHS Foundation Trust
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- UAB Division of Hematology/Oncology
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California
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Beverly Hills, California, Forenede Stater, 90210
- UCLA - Satellite Site
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Duarte, California, Forenede Stater, 91010
- City of Hope
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Encino, California, Forenede Stater, 93003
- UCLA - Satellite Site
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Irvine, California, Forenede Stater, 92618
- City of Hope - Irvine Lennar - Satellite
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Los Angles, California, Forenede Stater, 90095
- UCLA
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Pasadena, California, Forenede Stater, 91105
- The Oncology Institute of Hope & Innovation
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- USOR - Rocky Mountain Cancer Centers - Aurora
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06511
- Smilow Cancer Hospital - New Haven
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- Georgetown Lombardi Comprehensive Center
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40207
- Norton Cancer Institute - Saint Matthews
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- Maryland Oncology Hematology-Satellite
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Baltimore, Maryland, Forenede Stater, 21205
- The Sidney Kimmel Comprehensive Cancer Center
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Brandywine, Maryland, Forenede Stater, 21004
- Maryland Oncology Hematology-Satellite
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Columbia, Maryland, Forenede Stater, 21044
- Maryland Oncology Hematology
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Rockville, Maryland, Forenede Stater, 20850
- Maryland Oncology Hematology-Satellite
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Silver Spring, Maryland, Forenede Stater, 20904
- Maryland Oncology Hematology-Satellite
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Michigan
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Grand Rapids, Michigan, Forenede Stater, 49546
- The Cancer & Hematology Centers -Satellite Site
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Norton Shores, Michigan, Forenede Stater, 49444
- The Cancer & Hematology Centers of Muskegon
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
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New York
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, Forenede Stater, 10029
- Mount Sinai Health System
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North Carolina
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Durham, North Carolina, Forenede Stater, 27705
- Duke Cancer Institue
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45242
- USOR - Oncology Hematology Care - Kenwood
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Columbus, Ohio, Forenede Stater, 43214
- OhioHealth
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Columbus, Ohio, Forenede Stater, 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, Forenede Stater, 37232
- Vanderbilt Ingram Cancer Center
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Texas Oncology
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Houston, Texas, Forenede Stater, 77030
- University of Texas MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute
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Virginia
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Gainesville, Virginia, Forenede Stater, 20155
- USOR - Virginia Cancer Specialists - Gainesville Office
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Richmond, Virginia, Forenede Stater, 23298
- VCU Massey Cancer Center
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Virginia Beach, Virginia, Forenede Stater, 23456
- USOR - Virginia Oncology Associates - Virginia Beach
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Washington
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Seattle, Washington, Forenede Stater, 98109
- Fred Hutchinson Cancer Center - SCAA South Lake Union
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West Virginia
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Wheeling, West Virginia, Forenede Stater, 26003
- West Virginia University Cancer Institute, Wheeling Hospital
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin - Madison
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Paris, Frankrig, 75010
- Hôpital Saint-Louis
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Aquitaine
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Bordeaux, Aquitaine, Frankrig, 33000
- Institut Bergonié
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Aubergne
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Clermont-Ferrand, Aubergne, Frankrig, 63003
- Centre Hospitalier Universitaire Estaing
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Auvergne-Rhône-Alpes
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Pierre-Bénite, Auvergne-Rhône-Alpes, Frankrig, 69495
- Centre Hospitalier Lyon-Sud
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Brittany Region
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Brest, Brittany Region, Frankrig, 29200
- Hôpital Morvan
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Gard
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Nîmes, Gard, Frankrig, 30029
- Chu De Nîmes - Institut De Cancérologie Du Gard
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Grand Est
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Mulhouse, Grand Est, Frankrig, 68100
- Hôpital Emile Muller
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Hauts-de-France
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Lille, Hauts-de-France, Frankrig, 59037
- Hôpital Huriez
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Indre-et-Loire
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Tours, Indre-et-Loire, Frankrig, 37044
- Hôpital Bretonneau
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PACA
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Nice, PACA, Frankrig, 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, Frankrig, 49 933
- Centre Hospitalier Universitaire d'Angers
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Saint-Priest-en-Jarez, Pays de la Loire Region, Frankrig, 42271
- Centre Hospitalier Universitaire de Saint-Étienne
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Île-de-France Region
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Paris, Île-de-France Region, Frankrig, 75014
- Hôpital Cochin
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Paris, Île-de-France Region, Frankrig, 75013
- Hôpital Universitaire Pitié Salpêtrière
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Attica
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Athens, Attica, Grækenland, 124 62
- University General Hospital Attikon
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Athens, Attica, Grækenland, 115 27
- Laiko General Hospital of Athens
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Athens, Attica, Grækenland, 115 28
- General Hospital of Athens "Alexandra"
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Central Macedonia
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Thessaloniki, Central Macedonia, Grækenland, 570 10
- General Hospital of Thessaloniki George Papanikolaou
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Thessaly
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Ioánnina, Thessaly, Grækenland, 455 00
- University General Hospital of Ioannina
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Larissa, Thessaly, Grækenland, 41110
- University General Hospital of Larissa, Hematology Department
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Groningen, Holland, 9713 GZ
- Universitair Medisch Centrum Groningen
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North Holland
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Hoofddorp, North Holland, Holland, 2134 TM
- Spaarne Gasthuis - Hoofddorp
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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, Italien, 40138
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
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Florence, Italien, 50134
- Azienda Ospedaliero - Universitaria Careggi
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Pavia, Italien, 27100
- Fondazione IRCCS Policlinico San Matteo
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Roma, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Torino, Italien, 10128
- Azienda Ospedaliera Ordine Mauriziano di Torino
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Verona, Italien, 37134
- Centro Ricerche Cliniche di Verona
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Catania
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Catania, Catania, Italien, 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, Italien, 47014
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
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Genoa
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Genova, Genoa, Italien, 16132
- IRCCS Ospedale Policlinico San Martino
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Milan
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Milan, Milan, Italien, 20122
- Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
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Milan, Milan, Italien, 20141
- Istituto Europeo di Oncologia
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Milan, Milan, Italien, 20162
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Monza and Brianza
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Monza, Monza and Brianza, Italien, 20900
- Fondazione IRCCS San Gerardo dei Tintori
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Novara
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Novara, Novara, Italien, 28100
- Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
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Potenza
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Rionero in Vulture, Potenza, Italien, 85028
- IRCCS Centro di Riferimento Oncologico di Basilicata
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Rome
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Roma, Rome, Italien, 00161
- Umberto I - Policlinico di Roma
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Turin
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Torino, Turin, Italien, 10126
- Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
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Viterbo
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Rome, Viterbo, Italien, 00128
- Università Campus Bio-Medico di Roma
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Greater Poland Voivodeship
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Skórzewo, Greater Poland Voivodeship, Polen, 60-185
- AIDPORT
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Kuyavian-Pomeranian Voivodeship
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Torun, Kuyavian-Pomeranian Voivodeship, Polen, 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, Polen, 53-439
- Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polen, 20-093
- Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
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Podkarpackie Voivodeship
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Brzozów, Podkarpackie Voivodeship, Polen, 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, Polen, 80-952
- Uniwersyteckie Centrum Kliniczne w Gdańsku
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polen, 40-519
- Pratia Onkologia Katowice
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Wałbrzych, Silesian Voivodeship, Polen, 58-309
- Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
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Bucharest, Rumænien, 20125
- Spitalul Clinic Colentina
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Bucharest, Rumænien, 020125
- Coltea - Spital Clinic
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Iași, Rumænien, 700483
- Institutul Regional De Oncologie Iasi
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Cluj
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Cluj-Napoca, Cluj, Rumænien, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta
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Dolj
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Craiova, Dolj, Rumænien, 200136
- Spitalul Filantropia - Craiova
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Mureș County
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Târgu Mureş, Mureș County, Rumænien, 540136
- Spitalul Clinic Judetean De Urgenta Târgu Mureș
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Badalona, Spanien, 08916
- Institut Català d'Oncologia Badalona
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Barcelona, Spanien, 08036
- Hospital Clinic de Barcelona
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Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebrón
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Girona, Spanien, 17007
- Institut Català d'Oncologia Girona (ICO Girona)
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Las Palmas de Gran Canaria, Spanien, 35010
- Hospital Universitario de Gran Canaria Doctor Negrin
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Lugo, Spanien, 27003
- Hospital Universitario Lucus Augusti
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Marañón
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Madrid, Spanien, 28034
- Hospital Universitario Ramón y Cajal
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Murcia, Spanien, 30120
- Hospital Clínico Universitario Virgen de la Arrixaca
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Málaga, Spanien, 29010
- Hospital Universitario Virgen de la Victoria
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Salamanca, Spanien, 37007
- Complejo Asistencial Universitario de Salamanca - Hospital Clínico
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Valencia, Spanien, 46010
- Hospital Clínico Universitario de Valencia
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Cáceres
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Cáceres, Cáceres, Spanien, 10003
- Hospital San Pedro de Alcantara
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Principality of Asturias
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Oviedo, Principality of Asturias, Spanien, 33011
- Hospital Universitario Central de Asturias
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Zaragoza
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Zaragoza, Zaragoza, Spanien, 50012
- Hospital de Día Quirónsalud Zaragoza
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Daegu, Sydkorea, 41944
- Kyungpook National University Hospital
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Seoul, Sydkorea, 03080
- Seoul National University Hospital
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Seoul, Sydkorea, 03722
- Severance Hospital
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Seoul, Sydkorea, 6351
- Samsung Medical Center
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Seoul, Sydkorea, 06591
- The Catholic University of Korea - Seoul St. Mary's Hospital
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Gwang'Yeogsi
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Busan, Gwang'Yeogsi, Sydkorea, 49241
- Pusan National University Hospital
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Gyeonggido
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Seongnam-si, Gyeonggido, Sydkorea, 13605
- Seoul National University Bundang Hospital
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Jeollanam-do
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Hwasun, Jeollanam-do, Sydkorea, 58128
- Chonnam National University Hwasun Hospital
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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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Hradec Králové, Tjekkiet, 500 05
- Fakultní Nemocnice Hradec Králové
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Olomouc, Tjekkiet, 779 00
- Fakultní Nemocnice Olomouc
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Prague
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Prague, Prague, Tjekkiet, 128 08
- Vseobecna Fakultni Nemocnice v Praze
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Baden-Wurttemberg
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Mutlangen, Baden-Wurttemberg, Tyskland, 73557
- Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Tyskland, 40479
- Marien Hospital Düsseldorf
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Tyskland, 6120
- Universitätsklinikum Halle
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Tyskland, 24116
- Städtisches Krankenhaus Kiel
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Thuringia
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Jena, Thuringia, Tyskland, 7747
- Universitätsklinikum Jena
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Budapest, Ungarn, 1088
- Semmelweis Egyetem
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Győr-Moson-Sopron
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Győr, Győr-Moson-Sopron, Ungarn, 9023
- Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Andre navne:
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID. |
|
Eksperimentel: 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.
Andre navne:
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Andre navne:
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID. |
|
Eksperimentel: 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.
Andre navne:
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Andre navne:
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID. |
|
Eksperimentel: 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.
Andre navne:
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Andre navne:
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID. |
|
Aktiv komparator: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Fase 1: Maksimal tolereret dosis (MTD)
Tidsramme: Cirka inden for den første cyklus (28 dage) af behandlingen
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Cirka inden for den første cyklus (28 dage) af behandlingen
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Fase 1: Anbefalet fase 2-dosis (RP2D)
Tidsramme: Cirka inden for den første cyklus (28 dage) af behandlingen
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Cirka inden for den første cyklus (28 dage) af behandlingen
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Fase 1: Antal deltagere med uønskede hændelser (AE'er) efter forekomst, art og sværhedsgrad
Tidsramme: Fra start af lægemiddeladministration op til 30 dage efter sidste dosis af undersøgelsesbehandlingen (ca. 48 måneder)
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Fra start af lægemiddeladministration op til 30 dage efter sidste dosis af undersøgelsesbehandlingen (ca. 48 måneder)
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Fase 3: Andel af deltagere med miltvolumenreduktion (SVR) på større end eller lig med (>=) 35 procent (%) (SVR35) i uge 24 målt ved magnetisk resonansbilleddannelse (MRI) eller computertomografi (CT) scanning
Tidsramme: I uge 24
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I uge 24
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Fase 3: Absolut gennemsnitlig ændring i TSS (ABS-TSS) fra baseline til uge 24 målt ved myelofibrosis symptomvurderingsformular (MFSAF) v4.0
Tidsramme: I uge 24
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I uge 24
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Fase 3: Progressionsfri overlevelse (PFS)
Tidsramme: Tid fra randomisering til sygdomsprogression eller død, alt efter hvad der indtræffer først (ca. 48 måneder)
|
Tid fra randomisering til sygdomsprogression eller død, alt efter hvad der indtræffer først (ca. 48 måneder)
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Fase 3: Samlet overlevelse (OS)
Tidsramme: Fra baseline op til EOS (ca. 48 måneder)
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Fra baseline op til EOS (ca. 48 måneder)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
11. marts 2021
Primær færdiggørelse (Faktiske)
20. februar 2026
Studieafslutning (Anslået)
1. marts 2028
Datoer for studieregistrering
Først indsendt
14. september 2020
Først indsendt, der opfyldte QC-kriterier
18. september 2020
Først opslået (Faktiske)
24. september 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- XPORT-MF-034
- 2020-003883-19 (EudraCT nummer)
- 2023-506139-13-00 (Ctis)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .