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About the Study

This clinical trial is testing an investigational drug called selinexor for adults with previously treated myelofibrosis.

About Selinexor

Selinexor tablets are taken orally (by mouth). Before a drug can be approved for use by a health authority or regulatory agency to treat a specific disease or condition, it must be studied in clinical trials like this one. Selinexor is not approved as a treatment for myelofibrosis.

About this Trial

The main goals of this trial are:

To learn more about selinexor for patients with myelofibrosis. In particular, researchers will look at whether selinexor helps reduce spleen size and improve myelofibrosis symptoms compared with currently available treatments.

  • To learn more about the safety and tolerability of selinexor, including any side effects participants may have during the trial.
  • This trial is open to adults at least 18 years of age with myelofibrosis who have already been treated with a type of drug called a Janus kinase (JAK) inhibitor.

You can learn more about whether you might be eligible to join the trial by answering some screening questions (click the “Get Started” button on this page). Your doctor can also help you determine whether this trial might be a good fit for you.

Eligibility Criteria

Participants must:

  • Be at least 18 years old
  • Have a confirmed diagnosis of myelofibrosis
  • Have received treatment with a JAK inhibitor, such as ruxolitinib or fedratinib, for at least 6 months
  • Be able to attend trial site visits and complete trial assessments

Participants must not:

  • Have received previous treatment with selinexor
  • Have certain medical conditions, such as an uncontrolled infection or life-threatening illness, that might prevent the participant from completing study procedures or might make it unsafe for them to join the trial
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What Will Happen in this Trial

If you are interested in joining this trial, you will need to visit a trial site. Someone from the trial site will explain the trial to you. If you agree to join, the doctors and other site staff will give you an exam and ask you questions about your myelofibrosis and your medical history to make sure you are eligible.

People who join the trial will be randomly assigned to receive either selinexor or a physician’s choice of treatment.

  • If you are assigned to receive selinexor, you will take 80 milligrams of selinexor (four 20milligram tablets) once a week by mouth for the first 2 months, and then 60 milligrams (3 tablets) once a week after that.
  • If you are assigned to receive a physician’s choice of treatment, your trial doctor will choose a currently available myelofibrosis treatment that they think is your best treatment option. If your myelofibrosis does not respond to a physician’s choice of treatment, you might be eligible to switch to selinexor during the trial.

You will receive your assigned study treatment until your myelofibrosis gets worse or you decide to leave the trial. The trial doctor or the trial sponsor also has the right to discontinue a participant for safety issues or if the participant no longer meets the trial requirements. The entire trial is expected to last about 3 or 4 years.

During the trial, you will visit the trial site about once a month for a check-up. Every 3 months, the trial doctors will measure the size of your spleen using a noninvasive imaging tool, such as an MRI.

At home, you will be asked to keep track of your myelofibrosis symptoms daily by responding to a few questions on a smartphone. You will also be asked to use a scale each day that tracks your weight and body composition, and to wear a smartwatch that tracks your activity and monitors your sleep. The trial site will loan you a scale and smartwatch for this purpose during the trial. In addition, if you do not have a smartphone, the site will loan you a smartphone to keep track of your myelofibrosis symptoms.

The trial doctors and site staff will explain these and other procedures involved in the trial and answer any questions you might have before you decide whether you want to join.

Where You Can Join

This trial is being conducted in sites located in Europe and the United States, with the goal of enrolling 112 patients worldwide. For a full list of enrolling sites, please visit the trial listing on

VCU Massey Cancer Center, Richmond, Virginia, 23298, United States
Texas Oncology - Northeast Texas, Tyler, Texas, 75702, USA
University of New Mexico CCC /NMCCA, Albuquerque, New Mexico, 87131, USA
Southeast Clinical Research Center, Dalton, Georgia, 30720, USA
Huntsman Cancer Institute, Salt Lake City, Utah, 84112, USA
Illinois Cancer Specialists, Niles, IL, 60714, USA
Rocky Mountain Cancer Centers, LLP, Aurora, Colorado, 80012, USA
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Frequently Asked Questions (FAQs)