This clinical trial is focused on studying a condition called myelofibrosis, which is a type of blood cancer that affects the bone marrow. The study is testing the effectiveness and safety of a new treatment combination for patients who have not received any prior treatment for myelofibrosis. The treatment being studied includes a medication called selinexor, which is a selective inhibitor of nuclear export, used in combination with another medication called ruxolitinib. Ruxolitinib is already used to treat myelofibrosis, and this study aims to see if adding selinexor can improve outcomes for patients.
The purpose of the study is to compare the effects of the combination of selinexor and ruxolitinib with a placebo and ruxolitinib in patients with myelofibrosis. The study will look at how well the treatment reduces the size of the spleen, which is often enlarged in myelofibrosis, and how it affects symptoms and anemia, a condition where there is a lack of healthy red blood cells. The study will also monitor overall survival and response rates, which include complete and partial responses to the treatment.
Participants in the study will receive the treatment over a period of time, with regular assessments to monitor their response to the medication and any side effects. The study will use imaging techniques like MRI or CT scan to measure changes in spleen size and will assess symptoms using a specific form designed for myelofibrosis. The study is expected to continue until 2028, with recruitment starting in December 2023.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes measuring spleen volume using MRI or CT scan and evaluating symptoms of myelofibrosis (MF).
2treatment initiation
The treatment phase begins with the administration of ruxolitinib and selinexor. Ruxolitinib is provided in tablet form, with available dosages of 5 mg, 10 mg, 15 mg, and 20 mg. Selinexor is also administered orally.
The specific dosage and frequency of administration are determined by the study protocol and the patient’s condition.
3ongoing treatment and monitoring
Throughout the study, regular monitoring is conducted to assess the treatment’s effectiveness and any side effects. This includes periodic MRI or CT scans to measure spleen volume and symptom assessments using the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.
Additional medications such as ondansetron, netupitant, and palonosetron may be provided to manage side effects, administered orally as needed.
4evaluation at week 24
At week 24, a comprehensive evaluation is conducted to determine the proportion of patients achieving a reduction in spleen volume by at least 35% and a reduction in total symptom score by at least 50%.
Anemia response is also assessed according to established criteria.
5long-term follow-up
The study continues with long-term follow-up to monitor overall survival, progression-free survival, and other health outcomes.
The study is estimated to conclude by August 31, 2028, with ongoing assessments to ensure patient safety and treatment efficacy.
Who Can Join the Study?
Must be a patient who has not received treatment for MF (a type of blood cancer).
Must have a spleen volume of at least 450 cm3 as measured by an MRI or CT scan. These are imaging tests that help doctors see inside the body.
Must be in the DIPSS risk category of intermediate-1, intermediate-2, or high-risk. This is a way to assess the severity of the disease.
Must have an ECOG Performance Status of 2 or less. This is a scale that measures how well a patient can perform daily activities.
Must have a platelet count of at least 100 x 109/L without needing a platelet transfusion. Platelets are cells that help with blood clotting.
Must have active symptoms of MF, shown by having at least 2 symptoms with a score of 3 or more, or a total score of 10 or more at screening using the MFSAF V4.0. This is a tool used to measure symptoms.
Must be within the age range of 18 to 65 years old.
Both male and female patients can participate.
Participants should not be from a vulnerable population, meaning they should be able to give informed consent and understand the study.
Who Cannot Join the Study?
Patients who have already received treatment for their condition.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning they might need special protection or care.
Patients who do not meet other specific health criteria required for the study.
Selinexor is a medication being studied for its ability to treat myelofibrosis, a type of bone marrow cancer. It works by blocking a process in cells called nuclear export, which can help stop cancer cells from growing and spreading. In this trial, selinexor is being tested to see if it can improve the effectiveness of another medication, ruxolitinib, in patients who have not received treatment for myelofibrosis before.
Ruxolitinib is a medication used to treat myelofibrosis. It helps reduce symptoms and improve quality of life by targeting specific proteins involved in the growth of abnormal blood cells. In this study, ruxolitinib is used in combination with selinexor to see if the two medications together can provide better results for patients with myelofibrosis.
Myelofibrosis – Myelofibrosis is a rare type of bone marrow cancer that disrupts the body’s normal production of blood cells. It leads to extensive scarring in the bone marrow, which can result in severe anemia, weakness, fatigue, and an enlarged spleen. As the disease progresses, the bone marrow’s ability to produce blood cells diminishes, causing a shortage of red blood cells, white blood cells, and platelets. Patients may experience symptoms such as night sweats, fever, and bone pain. Over time, myelofibrosis can transform into a more aggressive form of leukemia. The condition is chronic and can vary greatly in its progression and symptoms among individuals.
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