Not recruiting

Study of Selinexor for Patients with Previously Treated Myelofibrosis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying myelofibrosis, a type of blood cancer that affects the bone marrow, leading to severe scarring and impacting the production of blood cells. The study will evaluate the effectiveness and safety of a medication called selinexor, which is taken as a film-coated tablet. Participants in the study will receive either selinexor or a treatment chosen by their doctor, which is referred to as the "physician's choice."

The purpose of the study is to determine how well selinexor works compared to the physician's choice in patients who have already received treatment for myelofibrosis. The study will involve regular check-ups and assessments to monitor the effects of the treatment. Participants will be randomly assigned to one of the two treatment groups and will continue with their assigned treatment for a specified period. The study will also look at how the treatment affects symptoms and overall health, including any changes in spleen size, which is often enlarged in myelofibrosis.

Throughout the study, participants will be closely monitored for any side effects or changes in their condition. The study aims to provide valuable information on the potential benefits of selinexor for patients with myelofibrosis, helping to guide future treatment options. The trial is designed to ensure the safety and well-being of all participants while gathering important data on the effectiveness of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure all criteria are met.
Step 2
Randomization
Participants will be randomly assigned to one of two groups: one receiving the study medication selinexor and the other receiving a treatment chosen by the physician.
Step 3
Treatment phase
If assigned to the selinexor group, the medication will be taken orally. The dosage and frequency will be determined by the study protocol and communicated by the healthcare team.
Participants in the physician's choice group will receive a treatment selected by their doctor, which may vary in dosage and frequency.
Step 4
Regular monitoring
Throughout the study, regular monitoring will occur. This includes scheduled visits to assess health status, monitor any side effects, and evaluate the effectiveness of the treatment.
Tests may include blood tests, imaging studies, and symptom assessments.
Step 5
End of treatment
At the end of the treatment period, a final assessment will be conducted. This will involve a comprehensive evaluation of health status and treatment outcomes.
Participants will be informed about the next steps and any follow-up care required.

Who can join the trial?

16 criteria

Must have a diagnosis of myelofibrosis (MF), which is a type of blood cancer, confirmed by a recent pathology report.
Must have a creatinine clearance (a measure of kidney function) greater than 15 mL/min.
Can have active hepatitis B if antiviral treatment has been given for more than 8 weeks and the viral load is less than 100 IU/mL.
Can have untreated hepatitis C if there is proof of a negative viral load.
Can have a history of HIV if CD4+ T-cell counts are 350 cells/microL or higher, the viral load is negative, and there have been no serious infections related to AIDS in the past year.
Female patients who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study and for at least 90 days after the last dose of the study drug.
Male patients who are sexually active must use effective birth control during the study and for at least 90 days after the last dose of the study drug, and must not donate sperm during this time.
Must sign a written consent form agreeing to participate in the study.
Must have been treated with JAK inhibitors (a type of medication) for at least 6 months.
Must have a measurable enlargement of the spleen, shown by a spleen volume of 450 cm³ or more on an MRI or CT scan.
Must have myelofibrosis that has returned, not responded to treatment, or cannot tolerate JAK inhibitors, as defined by specific criteria related to spleen size and treatment complications.
Must be 18 years of age or older.
Must have an ECOG performance status of 2 or less, which is a measure of daily living abilities.
Must have a platelet count of 75 x 10⁹/L or higher.
Must have an absolute neutrophil count (ANC) of 1.5 x 10⁹/L or higher, which is a type of white blood cell count.
Must have a serum direct bilirubin level of 1.5 times the upper limit of normal (ULN) or less, and AST and ALT levels of 2.5 times the ULN or less, which are measures of liver function.

Who cannot join the trial?

3 criteria

Patients who have not been previously treated for **myelofibrosis** cannot participate. **Myelofibrosis** is a type of blood cancer that affects the bone marrow.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to check if you meet the age criteria.
Patients who are part of a vulnerable population cannot participate. This typically includes groups like pregnant women, children, or those unable to give consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario 12 De Octubre
Verified
Madrid, Spain
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Verified
Meldola, Italy

Trial locations

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Investigated drugs

Selinexor is a medication being studied for its potential to treat myelofibrosis, a type of bone marrow cancer. It works by blocking a protein that helps cancer cells grow and spread. By inhibiting this protein, selinexor aims to slow down or stop the progression of the disease. In this clinical trial, selinexor is being tested as a single treatment option to see how effective it is compared to other treatments chosen by doctors.

Selinexor

What is already known about the treatment

Selinexor – Selinexor is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness and safety in treating myelofibrosis, a type of bone marrow cancer. The main therapeutic use of selinexor is to manage myelofibrosis in patients who have already received other treatments. At the molecular level, selinexor works by blocking a protein that helps cancer cells grow and survive, thereby slowing down or stopping the progression of the disease. It is classified as a selective inhibitor of nuclear export, which is a type of targeted cancer therapy.

Investigated diseases

Myelofibrosis – Myelofibrosis is a disorder where scar tissue forms in the bone marrow, disrupting the body's ability to produce blood cells. This condition leads to anemia, weakness, fatigue, and often an enlarged spleen. As the disease progresses, the bone marrow becomes increasingly fibrotic, further impairing blood cell production. Patients may experience symptoms such as night sweats, fever, and bone pain. Over time, the spleen and liver may enlarge due to the body's attempt to produce blood cells outside the bone marrow. The disease can also cause a variety of other symptoms, including weight loss and a feeling of fullness after eating small amounts.