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New drug hope for myelofibrosis patients with low platelets

NCT ID NCT05980806

Disease control Sponsor: Karyopharm Therapeutics Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests the drug selinexor in people with myelofibrosis who have not taken JAK inhibitors and have low to normal platelet counts. The main goal is to see if selinexor can shrink the spleen by at least 35% after 24 weeks. Researchers will also check if it improves symptoms and monitor for side effects. About 58 participants will receive either selinexor or a standard JAK inhibitor for comparison.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
selinexor (also known as KPT-330)
What this could lead to
If successful, selinexor could offer a new treatment option for myelofibrosis patients with low platelet counts who cannot use standard JAK inhibitors.
What could go wrong
This is an early Phase 2 study with only 58 participants, so results may not apply to everyone. Selinexor may cause side effects like nausea, fatigue, or low blood counts.
Why investors are watching

Karyopharm is testing its drug selinexor in patients with myelofibrosis who have not yet used JAK inhibitors and who have low to normal platelet counts. The trial measures whether the drug shrinks the spleen, a key sign of disease control. For a micro-cap company, this phase 2 readout could determine whether selinexor has a future in this patient group.

If it works: If the trial shows meaningful spleen reduction with acceptable safety, Karyopharm could advance selinexor to a larger study or seek regulatory discussions. That result would give the company a new potential use for its drug beyond its current approved indications.

If it fails: Phase 2 trials often fail to meet their goals, and a negative or unclear result could end this program. A delay in enrollment or data readout would also pressure the company, which depends on a small pipeline and limited resources.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * A diagnosis of MF or post-ET or post-PV MF according to the 2016 World Health Organization (WHO) classification of MPN, confirmed by the most recent local pathology report * Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (\>=) 450 cubic square centimeter (cm\^3) by MRI or CT scan (results from MRI or CT imaging performed within 28 days prior to C1D1 are acceptable) * DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk * ECOG Performance Status less than or equal to (\<=) 2 * Platelet count of greater than or equal to (\>=) 50 x 10\^9/L without platelet transfusion within 7 days prior to the first dose of selinexor * Absolute neutrophil count (ANC) \>=1.0 × 10\^9/L without need for growth factors within 7 days prior to the first dose of selinexor * Adequate liver function as defined by the following: aspartate transaminase (AST) and alanine transaminase (ALT) \<= 2.5 × upper limit normal (ULN) and serum total bilirubin \<= 3×ULN * Calculated creatinine clearance (CrCl) greater than (\>) 15 milliliter per minute (mL/min) based on the Cockcroft and Gault formula * Active symptoms of MF as determined by presence of at least 2 symptoms with an average score \>= 5 or total score of \>= 12 at screening (at least 5 of 7 consecutive days immediately preceding C1D1) using the MFSAF V4.0 * Must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study * Currently not eligible for stem cell transplantation * Must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50) Key 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 * Females who are pregnant or lactating * Prior splenectomy, splenic radiation, or a splenic embolization within 6 months prior to C1D1 * History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG), cerebrovascular accident (transient ischemic attack \[TIA\]), ventricular arrhythmias, congestive heart failure class \> 2 per New York Heart Association (NYHA) within 6 months of C1D1 * Unable to tolerate two forms of antiemetics prior to each dose for the first two cycles

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Conditions

The condition(s) this trial relates to.

myelofibrosis primary myelofibrosis thrombocytopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mild thrombocytopenia Moderate thrombocytopenia Myelofibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    70 sites in 19 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • "Georgios Papanikolaou" General Hospital of Thessaloniki

    RECRUITING

    Thessaloniki, Central Macedonia, 57010, Greece

  • AIDPORT

    RECRUITING

    Skórzewo, 30 60-185, Poland

  • Aarhus Universitetshospital

    RECRUITING

    Aarhus N, Central Jutland, 8200, Denmark

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

    RECRUITING

    Torino, Turin, 10126, Italy

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    RECRUITING

    Novara, 28100, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire

    RECRUITING

    Tours, Indre-et-Loire, 37044, France

  • Carmel Medical Center

    RECRUITING

    Haifa, 3436212, Israel

  • Centre Hospitalier Lyon-Sud

    RECRUITING

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

  • Centre Hospitalier Universitaire d'Angers

    RECRUITING

    Angers, Pays de la Loire Region, 49 933, France

  • Centre Hospitalier Universitaire de Saint-Etienne

    RECRUITING

    Saint-Priest-en-Jarez, 42270, France

  • Chu De Nîmes - Institut De Cancérologie Du Gard

    RECRUITING

    Nîmes, Occitanie, 30029, France

  • City of Hope - Duarte Main Site

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Coltea - Spital Clinic

    RECRUITING

    Bucharest, 30167, Romania

  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico

    RECRUITING

    Salamanca, 37007, Spain

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Fakultní nemocnice Olomouc

    RECRUITING

    Olomouc, 779 00, Czechia

  • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Milan, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, 27100, Italy

  • Guy's and Saint Thomas' NHS Foundation Trust

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Hematology Division, Mauriziano Hospital, University of Turin

    RECRUITING

    Orbassano, Torino, 10043, Italy

  • Hospital Clínico Universitario Virgen de la Arrixaca

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 8916, Spain

  • Hospital San Pedro de Alcantara

    RECRUITING

    Cáceres, 10003, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrin

    RECRUITING

    Las Palmas de Gran Canaria, 35010, Spain

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Hôpital Cochin

    RECRUITING

    Paris, 75014, France

  • Hôpital Saint-Louis

    RECRUITING

    Paris, 75010, France

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • IRCCS Ospedale Policlinico San Martino

    RECRUITING

    Genova, 16132, Italy

  • Institut Bergonié

    RECRUITING

    Bordeaux, Aquitaine, 33000, France

  • Institut Català d'Oncologia Girona

    RECRUITING

    Girona, 17007, Spain

  • Institutul Regional de Oncologie Iasi

    RECRUITING

    Iași, 700483, Romania

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

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

    RECRUITING

    Meldola, Italy

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Laiko General Hospital of Athens

    RECRUITING

    Athens, Attica, 11527, Greece

  • MD Anderson

    RECRUITING

    Houston, Texas, 77030, United States

  • Marien Hospital Düsseldorf

    RECRUITING

    Düsseldorf, 40479, Germany

  • Maryland Oncology Hematology - Independent of SCRI/ US Oncology

    RECRUITING

    Columbia, Maryland, 21044, United States

  • Medicover Clinical Integrated Systems Sp. z o.o.

    RECRUITING

    Torun, 87-100, Poland

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Pusan National University Hospital

    RECRUITING

    Busan, 49241, South Korea

  • Rambam Health Care Campus

    RECRUITING

    Haifa, 3109601, Israel

  • Research Institute of the McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    RECRUITING

    Lublin, 20-954, Poland

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1088, Hungary

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 3080, South Korea

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    RECRUITING

    Seocho, Seoul, 6591, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 3722, South Korea

  • Spaarne Gasthuis

    RECRUITING

    Hoofddorp, 2134 TM, Netherlands

  • Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia

    RECRUITING

    Sofia, 1756, Bulgaria

  • Spitalul Filantropia - Craiova

    RECRUITING

    Craiova, 200143, Romania

  • Taoyuan Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan, 333, Taiwan

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, Tel Aviv, 6423906, Israel

  • UZ Gent

    RECRUITING

    Ghent, 9000, Belgium

  • UZ Leuven - Campus Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • University General Hospital Attikon

    RECRUITING

    Athens, Attica, 124 62, Greece

  • University General Hospital of Ioannina, Hematology Department

    RECRUITING

    Ioannina, Epirus, 45500, Greece

  • University General Hospital of Larissa, Hematology Department

    RECRUITING

    Larissa, Thessaly, 41110, Greece

  • University Hospital Jena

    RECRUITING

    Jena, 7747, Germany

  • University Hospital Sv.Ivan Rilski - Sofia

    RECRUITING

    Sofia, 1431, Bulgaria

  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology

    RECRUITING

    Stara Zagora, 6003, Bulgaria

  • University Multiprofile Hospital for Active Treatment Aleksandrovska

    RECRUITING

    Sofia, 1431, Bulgaria

  • University Multiprofile Hospital for Active Treatment Sveti George - Base 1

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Università Campus Bio-Medico di Roma

    RECRUITING

    Rome, 128, Italy

  • Weill Cornell Medicine NewYork-Presbyterian

    RECRUITING

    New York, New York, 10021, United States

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