Study of Selinexor in Combination with Ruxolitinib in Myelofibrosis
Launched by KARYOPHARM THERAPEUTICS INC · Sep 18, 2020
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new combination of two medications, selinexor and ruxolitinib, to see if they can effectively treat myelofibrosis (MF), a type of bone marrow cancer. The trial has two parts: the first part has already been completed and focused on safety and finding the best dose of selinexor, while the second part, which is currently ongoing, is looking at how well this combination works compared to a placebo (a treatment with no active medication). The study is open to adults aged 18 and older who have certain types of MF and experience symptoms related to the condition.
To be eligible for this trial, participants must have a confirmed diagnosis of myelofibrosis, have measurable enlargement of the spleen, and meet specific health criteria, such as having a certain level of blood components without needing transfusions. Participants can expect to take the medications as part of the study and will be monitored closely for any side effects or changes in their condition. It's important to know that this trial is designed for individuals who are not currently eligible for stem cell transplantation and who have not previously received treatment for myelofibrosis. If you or a loved one is considering participation, it’s a great opportunity to help advance treatment options for this condition.
Gender
ALL
Eligibility criteria
- 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.
About Karyopharm Therapeutics Inc
Karyopharm Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for cancer and other serious diseases. With a strong focus on advancing novel therapies that leverage its proprietary SINE (Selective Inhibitor of Nuclear Export) technology, Karyopharm aims to disrupt the traditional approaches to oncology by targeting the nuclear export process of critical proteins. The company is committed to addressing unmet medical needs through rigorous scientific research and clinical trials, ultimately striving to improve patient outcomes and quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Salt Lake City, Utah, United States
New York, New York, United States
Madrid, , Spain
Duarte, California, United States
Barcelona, , Spain
Los Angeles, California, United States
Houston, Texas, United States
Hackensack, New Jersey, United States
Columbus, Ohio, United States
Nashville, Tennessee, United States
Antwerpen, , Belgium
Madrid, , Spain
Valencia, , Spain
Lugo, , Spain
Groningen, , Netherlands
Edmonton, Alberta, Canada
Kaohsiung, , Taiwan
Seoul, , Korea, Republic Of
Paris, , France
Madrid, , Spain
Madison, Wisconsin, United States
Seoul, , Korea, Republic Of
Barcelona, , Spain
Málaga, , Spain
Pavia, , Italy
Dallas, Texas, United States
London, , United Kingdom
Budapest, , Hungary
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Hradec Králové, , Czechia
Verona, , Italy
Richmond, Virginia, United States
Gent, Oost Vlaanderen, Belgium
Baltimore, Maryland, United States
Halle, Sachsen Anhalt, Germany
Bucuresti, , Romania
Tel Aviv, , Israel
Kaohsiung, , Taiwan
London, , United Kingdom
Columbia, Maryland, United States
Bordeaux, Aquitaine, France
Boston, , United Kingdom
Oviedo, Asturias, Spain
Taipei City, , Taiwan
Cluj Napoca, Cluj, Romania
Murcia, , Spain
New York, New York, United States
Torino, , Italy
Firenze, , Italy
Newcastle Upon Tyne, , United Kingdom
London, England, United Kingdom
Las Palmas De Gran Canaria, , Spain
Roma, , Italy
Clermont Ferrand, Aubergne, France
Kaohsiung, , Taiwan
Leuven, Flemish Brabant, Belgium
Seoul, , Korea, Republic Of
Oxford, England, United Kingdom
Jena, Thuringen, Germany
Olomouc, , Czechia
Milano, Milan, Italy
Brugge, West Vlaanderen, Belgium
Sofia, , Bulgaria
Dallas, Texas, United States
Wrocław, Dolnoslaskie, Poland
Hwasun Gun, , Korea, Republic Of
New Haven, Connecticut, United States
Louisville, Kentucky, United States
Salamanca, , Spain
Taichung City, Taichung, Taiwan
Sofia, , Bulgaria
Mutlangen, , Germany
Rionero In Vulture, Potenza, Italy
Torino, Turin, Italy
Novara, , Italy
Paris, Ile De France, France
Haifa, Haifa District, Israel
Jerusalem, Jerusalem District, Israel
Montreal, Quebec, Canada
Pasadena, California, United States
Aarhus N, Midtjylland, Denmark
Haifa, Haifa District, Israel
Gainesville, Virginia, United States
Athens, Attica, Greece
Birmingham, Alabama, United States
Bologna, , Italy
Beverly Hills, California, United States
Encino, California, United States
Durham, North Carolina, United States
Annapolis, Maryland, United States
Brandywine, Maryland, United States
Rockville, Maryland, United States
Silver Spring, Maryland, United States
Grand Rapids, Michigan, United States
Norton Shores, Michigan, United States
Meldola, Forli Cesena, Italy
Kiel, Schleswig Holstein, Germany
Monza, Monza And Brianza, Italy
Mulhouse, Grand Est, France
Tours Cedex, Indre Et Loire, France
Angers, Pays De La Loire, France
Be'er Ya'akov, Central District, Israel
Jerusalem, Jerusalem District, Israel
Nahariya, Northern District, Israel
Bucuresti, , Romania
Irvine, California, United States
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Jerusalem, Jerusalem District, Israel
Busan Gwang'yeogsi [Pusan Kwangyokshi], , Korea, Republic Of
Seongnam Si Gyeonggido [Kyonggi Do], , Korea, Republic Of
Seoul Teugbyeolsi [Seoul T'ukpyolshi], , Korea, Republic Of
Toruń, Kujawsko Pomorskie, Poland
Brzozów, Podkarpackie, Poland
Katowice, Slaskie, Poland
Moldova, Iasi, Romania
Aalborg, Nordjylland, Denmark
Mutlangen, Baden Württemberg, Germany
Düsseldorf, Nordrhein Westfalen, Germany
Rome, Viterbo, Italy
Skórzewo, Wielkopolskie, Poland
Boston, , United Kingdom
Liverpool, , United Kingdom
Wheeling, West Virginia, United States
Pierre Bénite, Rhone Alpes, France
Larissa, Thessaly, Greece
Genova, Genoa, Italy
Milano, Milan, Italy
Wałbrzych, Slaskie, Poland
Târgu Mureş, Mureș, Romania
Brest, Bretagne, France
Los Angles, California, United States
Seattle, Washington, United States
Antwerpen, , Belgium
Praha 2, Prague, Czech Republic
Nimes, Gard, France
Lille, Hauts De France, France
Saint Priest En Jarez, Loire, France
Nice Cedex 3, Provence Alpes Côte D'azur, France
Athens, Attica, Greece
Thessaloniki, Central Macedonia, Greece
Győr, Gyor Moson Sopron, Hungary
Ramat Gan, Central District, Israel
Afula, Northern District, Israel
Lublin, Lubelskie, Poland
Gdańsk, Pomorskie, Poland
Craiova, Dolj, Romania
Girona, , Spain
Taoyuan, , Taiwan
Aurora, Colorado, United States
Cincinnati, Ohio, United States
Virginia Beach, Virginia, United States
Nice Cedex 3, Paca, France
Milano, Milan, Italy
Badalona, , Spain
Târgu Mureş, , Romania
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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