Actively Recruiting
A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Led by Karyopharm Therapeutics Inc · Updated on 2026-02-12
58
Participants Needed
70
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating selinexor, a drug, in people with myelofibrosis (MF) who have not previously been treated with JAK inhibitors and who have normal or mildly to moderately low platelet counts. The main goal is to see if selinexor can reduce spleen size by at least 35% after 24 weeks. The study also looks at other measures of effectiveness and safety during the treatment period. Participants receive oral selinexor tablets once weekly, either 60 mg or 40 mg, taken on days 1, 8, 15, and 22 of each 28-day cycle. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. Based on how the spleen responds at weeks 12 or 24, additional medications may be added to the treatment plan. During the study, participants will provide bone marrow biopsy samples and complete daily symptom assessments using a special questionnaire. Researchers will monitor spleen volume, symptom changes, and any side effects from the treatment. The study is planned to last up to about 48 months, allowing for long-term safety and effectiveness evaluation.
CONDITIONS
Brief Title
A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myelofibrosis or post-ET or post-PV MF confirmed by recent pathology
- Measurable enlarged spleen with volume ≥ 450 cm³ by MRI or CT scan
- DIPSS risk category of intermediate-1 with symptoms, intermediate-2, or high-risk
- ECOG Performance Status ≤ 2
- Platelet count ≥ 50 x 10⁹/L without transfusion within 7 days before first selinexor dose
- Absolute neutrophil count ≥ 1.0 x 10⁹/L without growth factors within 7 days before first selinexor dose
- Adequate liver function (AST and ALT ≤ 2.5 x ULN; total bilirubin ≤ 3 x ULN)
- Creatinine clearance > 15 mL/min calculated by Cockcroft and Gault formula
- Active symptoms with at least 2 symptoms scoring average ≥ 5 or total score ≥ 12 on MFSAF V4.0
- Willing to provide bone marrow biopsy samples at screening and during study
- Not currently eligible for stem cell transplantation
- Willing to complete daily MFSAF V4.0 symptom assessments during study
You will not qualify if you...
- More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)
- Previous treatment with JAK inhibitors for myelofibrosis
- Previous treatment with selinexor or other XPO1 inhibitors
- Pregnant or lactating females
- Prior splenectomy, splenic radiation, or embolization within 6 months before first selinexor dose
- History of recent serious heart conditions or events within 6 months before first selinexor dose
- Unable to tolerate two forms of antiemetics before each dose during first two cycles
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression, intolerable toxicity, or study discontinuation
Participants receive selinexor oral tablets once weekly in 28-day cycles. Treatment continues until disease progression, intolerable toxicity, or criteria for discontinuation are met. Optional add-on medications may be started based on spleen volume reduction at Week 12 or Week 24.
Weekly visits for dosing on Days 1, 8, 15, and 22 of each 28-day cycle
Trial Site Locations
Total: 70 locations
1
City of Hope - Duarte Main Site
Duarte, California, United States, 91010
Actively Recruiting
2
Maryland Oncology Hematology - Independent of SCRI/ US Oncology
Columbia, Maryland, United States, 21044
Actively Recruiting
3
Weill Cornell Medicine NewYork-Presbyterian
New York, New York, United States, 10021
Actively Recruiting
4
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
5
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
6
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
7
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
8
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
9
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
10
University Multiprofile Hospital for Active Treatment Sveti George - Base 1
Plovdiv, Bulgaria, 4002
Actively Recruiting
11
University Hospital Sv.Ivan Rilski - Sofia
Sofia, Bulgaria, 1431
Actively Recruiting
12
University Multiprofile Hospital for Active Treatment Aleksandrovska
Sofia, Bulgaria, 1431
Actively Recruiting
13
Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
Sofia, Bulgaria, 1756
Actively Recruiting
14
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology
Stara Zagora, Bulgaria, 6003
Actively Recruiting
15
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
16
Fakultní nemocnice Olomouc
Olomouc, Czechia, 779 00
Actively Recruiting
17
Aarhus Universitetshospital
Aarhus N, Central Jutland, Denmark, 8200
Actively Recruiting
18
Institut Bergonié
Bordeaux, Aquitaine, France, 33000
Actively Recruiting
19
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
Actively Recruiting
20
CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire
Tours, Indre-et-Loire, France, 37044
Actively Recruiting
21
Chu De Nîmes - Institut De Cancérologie Du Gard
Nîmes, Occitanie, France, 30029
Actively Recruiting
22
Centre Hospitalier Universitaire d'Angers
Angers, Pays de la Loire Region, France, 49 933
Actively Recruiting
23
Hôpital Saint-Louis
Paris, France, 75010
Actively Recruiting
24
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
25
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
26
Marien Hospital Düsseldorf
Düsseldorf, Germany, 40479
Actively Recruiting
27
University Hospital Jena
Jena, Germany, 7747
Actively Recruiting
28
Laiko General Hospital of Athens
Athens, Attica, Greece, 11527
Actively Recruiting
29
University General Hospital Attikon
Athens, Attica, Greece, 124 62
Actively Recruiting
30
"Georgios Papanikolaou" General Hospital of Thessaloniki
Thessaloniki, Central Macedonia, Greece, 57010
Actively Recruiting
31
University General Hospital of Ioannina, Hematology Department
Ioannina, Epirus, Greece, 45500
Actively Recruiting
32
University General Hospital of Larissa, Hematology Department
Larissa, Thessaly, Greece, 41110
Actively Recruiting
33
Semmelweis Egyetem
Budapest, Hungary, 1088
Actively Recruiting
34
Tel Aviv Sourasky Medical Center
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
35
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
36
Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
37
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
Milan, Milan, Italy, 20122
Actively Recruiting
38
Hematology Division, Mauriziano Hospital, University of Turin
Orbassano, Torino, Italy, 10043
Actively Recruiting
39
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Turin, Italy, 10126
Actively Recruiting
40
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
41
IRCCS Ospedale Policlinico San Martino
Genova, Italy, 16132
Actively Recruiting
42
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST
Meldola, Italy
Actively Recruiting
43
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
44
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
45
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Italy, 28100
Actively Recruiting
46
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
47
Università Campus Bio-Medico di Roma
Rome, Italy, 128
Actively Recruiting
48
Spaarne Gasthuis
Hoofddorp, Netherlands, 2134 TM
Actively Recruiting
49
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland, 20-954
Actively Recruiting
50
AIDPORT
Skórzewo, Poland, 30 60-185
Actively Recruiting
51
Medicover Clinical Integrated Systems Sp. z o.o.
Torun, Poland, 87-100
Actively Recruiting
52
Coltea - Spital Clinic
Bucharest, Romania, 30167
Actively Recruiting
53
Spitalul Filantropia - Craiova
Craiova, Romania, 200143
Actively Recruiting
54
Institutul Regional de Oncologie Iasi
Iași, Romania, 700483
Actively Recruiting
55
Seoul St. Mary's Hospital, The Catholic University of Korea
Seocho, Seoul, South Korea, 6591
Actively Recruiting
56
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 3080
Actively Recruiting
57
Severance Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 3722
Actively Recruiting
58
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
59
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 8916
Actively Recruiting
60
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
61
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
62
Hospital San Pedro de Alcantara
Cáceres, Spain, 10003
Actively Recruiting
63
Institut Català d'Oncologia Girona
Girona, Spain, 17007
Actively Recruiting
64
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Spain, 35010
Actively Recruiting
65
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, Spain, 37007
Actively Recruiting
66
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
67
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
68
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
69
Taoyuan Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
70
Guy's and Saint Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
Research Team
K
Karyopharm Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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