Study of Selinexor in Combination with Ruxolitinib in Myelofibrosis

Phase

Condition

Myelofibrosis

Post-polycythemia Vera Myelofibrosis

Treatment

Ruxolitinib

Placebo

Selinexor

Clinical Study ID

NCT04562389

XPORT-MF-034

2020-003883-19

2023-506139-13-00

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Aged ≥ 18 years
A diagnosis of primary MF or post-essential thrombocythemia (ET) orpostpolycythemia- vera (PV) MF.
Active symptoms of MF as determined by presence of at least 2 symptoms using theMyelofibrosis Symptom Assessment Form (MFSAF) V4.0.
Participants with international prognostic scoring system (DIPSS) risk category ofintermediate-1, or intermediate-2, or high-risk.
Measurable splenomegaly during the screening period as demonstrated by spleen volumeof greater than or equal to (>=) 450 cubic centimeter (cm^3) .
Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (<=) 2.

Exclusion

Exclusion Criteria:

More than 10% blasts in peripheral blood or bone marrow (accelerated or blastphase).
Previous treatment with JAK inhibitors for MF.
Previous treatment with selinexor or other XPO1 inhibitors.

Study Design

Ruxolitinib

March 11, 2021

March 31, 2028

Connect with a study center

Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant 3000
Belgium
Active - Recruiting
Universitair Ziekenhuis Gent
Gent, Oost-Vlaanderen 9000
Belgium
Active - Recruiting
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Brugge, West-Vlaanderen 8000
Belgium
Active - Recruiting
ZNA Stuivenberg
Antwerpen, 2060
Belgium
Active - Recruiting
ZNA Stuivenberg - Satelite
Antwerpen, 2030
Belgium
Active - Recruiting
University Multiprofile Hospital for Active Treatment Sveti George - Base 1
Plovdiv, 4002
Bulgaria
Active - Recruiting
Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
Sofia, 1797
Bulgaria
Active - Recruiting
University Multiprofile Hospital for Active Treatment Aleksandrovska
Sofia, 1431
Bulgaria
Active - Recruiting
University Multiprofile Hospital for Active Treatment St. Ivan Rilski
Sofia, 1431
Bulgaria
Active - Recruiting
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich
Stara Zagora, 6003
Bulgaria
Active - Recruiting
University of Alberta Hospital
Edmonton, Alberta T6G 2G3
Canada
Active - Recruiting
Research Institute of the McGill University Health Centre
Montreal, Quebec H4A 3J1
Canada
Active - Recruiting
Vseobecna Fakultni Nemocnice v Praze
Praha 2, Prague 128 08
Czech Republic
Active - Recruiting
Fakultní Nemocnice Hradec Králové
Hradec Králové, 500 05
Czechia
Active - Recruiting
Fakultní Nemocnice Olomouc
Olomouc, 779 00
Czechia
Active - Recruiting
Aarhus Universitetshospital
Aarhus N, Midtjylland 8200
Denmark
Active - Recruiting
Tang Severinsen, Marianne
Aalborg, Nordjylland 9000
Denmark
Active - Recruiting
Institut Bergonié
Bordeaux, Aquitaine 33000
France
Active - Recruiting
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, Aubergne 63003
France
Active - Recruiting
Hôpital Morvan
Brest, Bretagne 29200
France
Active - Recruiting
Chu De Nîmes - Institut De Cancérologie Du Gard
Nimes, Gard 30029
France
Active - Recruiting
Hôpital Emile Muller
Mulhouse, Grand Est 68100
France
Active - Recruiting
Hôpital Huriez
Lille, Hauts-de-France 59037
France
Active - Recruiting
Hôpital Universitaire Pitié Salpêtrière
Paris, Ile-de-France 75013
France
Active - Recruiting
Hôpital Bretonneau
Tours Cedex, Indre-et-Loire 37044
France
Active - Recruiting
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Priest-en-Jarez, Loire 42271
France
Active - Recruiting
Hôpital l'Archet - CHU Nice
Nice Cedex 3, Paca 06202
France
Active - Recruiting
Centre Hospitalier Universitaire d'Angers
Angers, Pays de la Loire 49 933
France
Active - Recruiting
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Rhone-Alpes 69495
France
Active - Recruiting
Hôpital Saint-Louis
Paris, 75010
France
Active - Recruiting
Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
Mutlangen, Baden-Württemberg 73557
Germany
Active - Recruiting
Marien Hospital Düsseldorf
Düsseldorf, Nordrhein-Westfalen 40479
Germany
Active - Recruiting
Universitätsklinikum Halle
Halle, Sachsen-Anhalt 6120
Germany
Active - Recruiting
Städtisches Krankenhaus Kiel
Kiel, Schleswig-Holstein 24116
Germany
Active - Recruiting
Universitätsklinikum Jena
Jena, Thuringen 7747
Germany
Active - Recruiting
Laiko General Hospital of Athens
Athens, Attica 115 27
Greece
Active - Recruiting
University General Hospital Attikon
Athens, Attica 124 62
Greece
Active - Recruiting
General Hospital of Thessaloniki George Papanikolaou
Thessaloniki, Central Macedonia 570 10
Greece
Active - Recruiting
University General Hospital of Larissa, Hematology Department
Larissa, Thessaly 41110
Greece
Active - Recruiting
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, Gyor-Moson-Sopron 9023
Hungary
Active - Recruiting
Semmelweis Egyetem
Budapest, 1088
Hungary
Active - Recruiting
Shamir Medical Center (Assaf Harofeh)
Be'er Ya'akov, Central District 7030000
Israel
Active - Recruiting
The Chaim Sheba Medical Center
Ramat Gan, Central District 5265601
Israel
Active - Recruiting
Carmel Medical Center
Haifa, Haifa District 3436212
Israel
Active - Recruiting
Rambam Health Care Campus
Haifa, Haifa District 3109601
Israel
Active - Recruiting
Hadassah University Hospital - Mount Scopus
Jerusalem, Jerusalem District 9112001
Israel
Active - Recruiting
Hadassah University Hospital - Mount Scopus - Satellite Site
Jerusalem, Jerusalem District 9112001
Israel
Active - Recruiting
Hadassah University Hospital Ein Kerem
Jerusalem, Jerusalem District 9112001
Israel
Active - Recruiting
Emek Medical Center
Afula, Northern District 1834111
Israel
Active - Recruiting
Western Galilee Hospital-Nahariya
Nahariya, Northern District 2210001
Israel
Active - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Israel
Active - Recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forli-Cesena 47014
Italy
Active - Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Meldola, Forlì-Cesena
Italy
Site Not Available
IRCCS Ospedale Policlinico San Martino
Genova, Genoa 16132
Italy
Active - Recruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano, Milan 20162
Italy
Active - Recruiting
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
Milano, Milan 20122
Italy
Active - Recruiting
Istituto Europeo di Oncologia
Milano, Milan 20141
Italy
Active - Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza and Brianza 20900
Italy
Active - Recruiting
IRCCS Centro di Riferimento Oncologico di Basilicata
Rionero In Vulture, Potenza 85028
Italy
Active - Recruiting
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Turin 10126
Italy
Active - Recruiting
Università Campus Bio-Medico di Roma
Rome, Viterbo 00128
Italy
Active - Recruiting
Aou Policlinico S. Orsola - UO Ematologia
Bologna,
Italy
Site Not Available
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna, 40138
Italy
Active - Recruiting
Azienda Ospedaliero - Universitaria Careggi
Firenze, 50134
Italy
Active - Recruiting
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, 28100
Italy
Active - Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Italy
Active - Recruiting
University of Perugia Department of Medicine Hematology Section
Perugia, 06132
Italy
Site Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Italy
Active - Recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128
Italy
Active - Recruiting
Asst Settelaghi, Ospedale Di Circolo E Fondazione Macchi
Varese,
Italy
Site Not Available
Centro Ricerche Cliniche di Verona
Verona, 37134
Italy
Active - Recruiting
Pusan National University Hospital
Busan Gwang'yeogsi [Pusan-Kwangyokshi], 49241
Korea, Republic of
Active - Recruiting
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic of
Active - Recruiting
Chonnam National University Hwasun Hospital
Hwasun-gun, 58128
Korea, Republic of
Active - Recruiting
Seoul National University Bundang Hospital
Seongnam-si Gyeonggido [Kyonggi-do], 13605
Korea, Republic of
Active - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Active - Recruiting
Severance Hospital
Seoul, 03722
Korea, Republic of
Active - Recruiting
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic of
Active - Recruiting
Samsung Medical Center
Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6351
Korea, Republic of
Active - Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Netherlands
Active - Recruiting
Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
Wrocław, Dolnoslaskie 53-439
Poland
Active - Recruiting
Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Toruń
Toruń, Kujawsko-Pomorskie 87-100
Poland
Active - Recruiting
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, Lubelskie 20-093
Poland
Active - Recruiting
Szpital Specjalistyczny w Brzozowie - Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów, Podkarpackie 36-200
Poland
Active - Recruiting
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdańsk, Pomorskie 80-952
Poland
Active - Recruiting
Pratia Onkologia Katowice
Katowice, Slaskie 40-519
Poland
Active - Recruiting
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
Wałbrzych, Slaskie 58-309
Poland
Active - Recruiting
AIDPORT
Skórzewo, Wielkopolskie 60-185
Poland
Active - Recruiting
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj 400015
Romania
Active - Recruiting
Spitalul Filantropia - Craiova
Craiova, Dolj 200136
Romania
Active - Recruiting
Institutul Regional De Oncologie Iasi
Moldova, Iasi 700483
Romania
Active - Recruiting
Spitalul Clinic Judetean De Urgenta Târgu Mureș
Târgu Mureş, Mureș 540136
Romania
Active - Recruiting
Coltea - Spital Clinic
Bucuresti, 020125
Romania
Active - Recruiting
Spitalul Clinic Colentina
Bucuresti, 20125
Romania
Active - Recruiting
Hospital Universitario Central de Asturias
Oviedo, Asturias 33011
Spain
Active - Recruiting
Institut Català d'Oncologia Badalona
Badalona, 08916
Spain
Active - Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Active - Recruiting
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
Spain
Active - Recruiting
Institut Català d'Oncologia Girona (ICO Girona)
Girona, 17007
Spain
Active - Recruiting
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, 35010
Spain
Active - Recruiting
Hospital Universitario Lucus Augusti
Lugo, 27003
Spain
Active - Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Spain
Active - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Active - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Spain
Active - Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Spain
Active - Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Spain
Active - Recruiting
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, 37007
Spain
Active - Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
Spain
Active - Recruiting
China Medical University Hospital
Taichung City, Taichung 40447
Taiwan
Active - Recruiting
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung, 83301
Taiwan
Active - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 80756
Taiwan
Active - Recruiting
National Taiwan University Hospital
Taipei City, 10048
Taiwan
Active - Recruiting
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan, 33305
Taiwan
Active - Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, England SE1 9RT
United Kingdom
Active - Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, England OX3 7LE
United Kingdom
Active - Recruiting
United Lincolnshire Hospitals NHS Trust
Boston, PE21 9QS
United Kingdom
Active - Recruiting
United Lincolnshire Hospitals NHS Trust-Satellite Site
Boston, PE21 9QS
United Kingdom
Active - Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, LZ 8XP
United Kingdom
Active - Recruiting
Imperial College Healthcare NHS Trust
London, W12 0HS
United Kingdom
Active - Recruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne, NE7 7DN
United Kingdom
Active - Recruiting
UAB Division of Hematology/Oncology
Birmingham, Alabama 35294
United States
Active - Recruiting
UCLA - Satellite Site
Beverly Hills, California 90210
United States
Active - Recruiting
City of Hope
Duarte, California 91010
United States
Active - Recruiting
UCLA - Satellite Site
Encino, California 93003
United States
Active - Recruiting
City of Hope - Irvine Lennar - Satellite
Irvine, California 92618
United States
Active - Recruiting
UCLA
Los Angeles, California 90095
United States
Site Not Available
UCLA
Los Angles, California 90095
United States
Active - Recruiting
The Oncology Institute of Hope & Innovation
Pasadena, California 91105
United States
Site Not Available
USOR - Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado 80045
United States
Active - Recruiting
Smilow Cancer Hospital - New Haven
New Haven, Connecticut 06511
United States
Active - Recruiting
Norton Cancer Institute - Saint Matthews
Louisville, Kentucky 40207
United States
Active - Recruiting
Maryland Oncology Hematology-Satellite
Annapolis, Maryland 21401
United States
Active - Recruiting
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21205
United States
Active - Recruiting
Maryland Oncology Hematology-Satellite
Brandywine, Maryland 21004
United States
Active - Recruiting
Maryland Oncology Hematology
Columbia, Maryland 21044
United States
Active - Recruiting
Maryland Oncology Hematology-Satellite
Rockville, Maryland 20850
United States
Active - Recruiting
Maryland Oncology Hematology-Satellite
Silver Spring, Maryland 20904
United States
Active - Recruiting
The Cancer & Hematology Centers -Satellite Site
Grand Rapids, Michigan 49546
United States
Active - Recruiting
The Cancer & Hematology Centers of Muskegon
Norton Shores, Michigan 49444
United States
Active - Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Active - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Active - Recruiting
Mount Sinai Health System
New York, New York 10029
United States
Active - Recruiting
Duke Cancer Institue
Durham, North Carolina 27705
United States
Active - Recruiting
USOR - Oncology Hematology Care - Kenwood
Cincinnati, Ohio 45242
United States
Active - Recruiting
OhioHealth
Columbus, Ohio 43214
United States
Active - Recruiting
Vanderbilt Ingram Cancer Center
Nashville, Tennessee 37232
United States
Active - Recruiting
Texas Oncology
Dallas, Texas 75246
United States
Active - Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Active - Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Active - Recruiting
USOR - Virginia Cancer Specialists - Gainesville Office
Gainesville, Virginia 20155
United States
Active - Recruiting
VCU Massey Cancer Center
Richmond, Virginia 23298
United States
Active - Recruiting
USOR - Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia 23456
United States
Active - Recruiting
Fred Hutchinson Cancer Center - SCAA South Lake Union
Seattle, Washington 98109
United States
Active - Recruiting
West Virginia University Cancer Institute, Wheeling Hospital
Wheeling, West Virginia 26003
United States
Active - Recruiting
University of Wisconsin - Madison
Madison, Wisconsin 53792
United States
Active - Recruiting

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Study of Selinexor in Combination with Ruxolitinib in Myelofibrosis

Phase

Condition

Treatment

Clinical Study ID

Study Summary

Eligibility Criteria

Inclusion

Exclusion

Study Design

Connect with a study center

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Universitair Ziekenhuis Gent

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

ZNA Stuivenberg

ZNA Stuivenberg - Satelite

University Multiprofile Hospital for Active Treatment Sveti George - Base 1

Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia

University Multiprofile Hospital for Active Treatment Aleksandrovska

University Multiprofile Hospital for Active Treatment St. Ivan Rilski

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

University of Alberta Hospital

Research Institute of the McGill University Health Centre

Vseobecna Fakultni Nemocnice v Praze

Fakultní Nemocnice Hradec Králové

Fakultní Nemocnice Olomouc

Aarhus Universitetshospital

Tang Severinsen, Marianne

Institut Bergonié

Centre Hospitalier Universitaire Estaing

Hôpital Morvan

Chu De Nîmes - Institut De Cancérologie Du Gard

Hôpital Emile Muller

Hôpital Huriez

Hôpital Universitaire Pitié Salpêtrière

Hôpital Bretonneau

Centre Hospitalier Universitaire de Saint-Étienne

Hôpital l'Archet - CHU Nice

Centre Hospitalier Universitaire d'Angers

Centre Hospitalier Lyon-Sud

Hôpital Saint-Louis

Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd

Marien Hospital Düsseldorf

Universitätsklinikum Halle

Städtisches Krankenhaus Kiel

Universitätsklinikum Jena

Laiko General Hospital of Athens

University General Hospital Attikon

General Hospital of Thessaloniki George Papanikolaou

University General Hospital of Larissa, Hematology Department

Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

Semmelweis Egyetem

Shamir Medical Center (Assaf Harofeh)

The Chaim Sheba Medical Center

Carmel Medical Center

Rambam Health Care Campus

Hadassah University Hospital - Mount Scopus

Hadassah University Hospital - Mount Scopus - Satellite Site

Hadassah University Hospital Ein Kerem

Emek Medical Center

Western Galilee Hospital-Nahariya

Tel Aviv Sourasky Medical Center

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

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

IRCCS Ospedale Policlinico San Martino

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

Istituto Europeo di Oncologia

Fondazione IRCCS San Gerardo dei Tintori

IRCCS Centro di Riferimento Oncologico di Basilicata

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

Università Campus Bio-Medico di Roma

Aou Policlinico S. Orsola - UO Ematologia

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

Azienda Ospedaliero - Universitaria Careggi

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Fondazione IRCCS Policlinico San Matteo

University of Perugia Department of Medicine Hematology Section

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Azienda Ospedaliera Ordine Mauriziano di Torino

Institut Català d'Oncologia Girona (ICO Girona)