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Study of RVU120 and Ruxolitinib for Patients with Intermediate or High-Risk Myelofibrosis

Fast replyRegistered 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 a condition called Myelofibrosis, which is a type of blood cancer that affects the bone marrow. The trial will test a new investigational drug called RVU120, both on its own and in combination with another medication known as Ruxolitinib (also referred to by its code name, INCB018424). The purpose of the study is to evaluate the effectiveness of RVU120 in treating myelofibrosis, either alone or when used together with Ruxolitinib.

Participants in the study will receive either RVU120 or a combination of RVU120 and Ruxolitinib. The study will last for a period of up to 24 months. During this time, participants will be monitored to see how their condition responds to the treatment. The study will involve regular check-ups and assessments, including imaging tests like MRI or CT scans, to measure changes in the size of the spleen, which is often enlarged in myelofibrosis. The study will also look at other factors such as symptom improvement and overall health outcomes.

Throughout the trial, the safety and side effects of the treatments will be closely observed. Participants will be asked to report any changes in their symptoms or any new symptoms they experience. The trial aims to provide valuable information on the potential benefits and risks of using RVU120, alone or with Ruxolitinib, for treating myelofibrosis. This research could lead to new treatment options for patients with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the trial's purpose and procedures. The participant will provide informed consent, confirming understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes evaluating liver and kidney function, blood counts, and overall health status. A pregnancy test will be conducted for women of childbearing potential.

  3. Step 3

    Treatment phase

    The participant will receive the investigational drug RVU120 either alone or in combination with ruxolitinib. The specific treatment regimen will depend on the participant's cohort assignment.

    For those receiving ruxolitinib, the medication will be administered orally in tablet form. Dosages may include Jakavi 5 mg, 15 mg, or 20 mg tablets, taken as prescribed by the study team.

    Participants may also receive SEL120 monohydrochloride in capsule form, taken orally as directed.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will occur throughout the study to assess the participant's response to treatment and any side effects. This includes imaging tests like MRI or CT scans to measure spleen size and blood tests to monitor health status.

    Participants will be evaluated for symptom improvement and any changes in their condition. The study team will track the duration of spleen response and any potential progression of the disease.

  5. Step 5

    End of treatment

    After completing the treatment phase, participants will undergo a final assessment to evaluate the overall impact of the treatment. This includes measuring any changes in spleen size, symptom scores, and overall health.

  6. Step 6

    Post-study follow-up

    Participants will be monitored for a period after the study to observe any long-term effects of the treatment. This includes regular health check-ups and assessments as needed.

Who can join the trial?

13 criteria

  • Must be at least 18 years old at the time of giving consent to participate.
  • Must have proper liver function, which means certain liver enzymes and bilirubin levels should be within specific limits.
  • If a woman can have children, she must have a negative pregnancy test before starting the study and use a reliable method of birth control during the study and for about 6.5 months after the last dose. Men must use a barrier method of birth control if they are sexually active with a woman who can have children, and their partners should also use effective birth control for the same period.
  • Must agree not to donate blood, eggs, or sperm during the study and for about 6.5 months after the last dose.
  • The study doctor must believe the participant is suitable for the study, understands what is required, can follow the study rules, and is reliable and cooperative.
  • Must have a diagnosis of primary or secondary myelofibrosis (MF), a type of blood cancer, according to specific medical criteria.
  • Must have intermediate or high-risk disease according to a specific scoring system for MF.
  • For certain groups in the study, participants must have specific responses or lack of response to previous treatments with JAK inhibitors, a type of medication used for MF.
  • Must have a measurable enlarged spleen, which can be felt or measured by imaging tests like MRI or CT.
  • Must have active symptoms of MF, such as night sweats, itchiness, abdominal discomfort, pain under ribs on the left side, feeling full quickly, bone or muscle pain, and inactivity, with specific scores on a symptom scale.
  • Must have an ECOG performance score of 0-2, which measures the ability to perform daily activities.
  • Must have proper blood function, meaning certain blood cell counts should be within specific limits.
  • Must have proper kidney function, which means a certain level of creatinine clearance, a measure of kidney health, should be met.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer than 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 typically defined by the study organizers.
  • Patients who are not part of the specified clinical trial group cannot participate. Clinical trial groups are categories of patients that the study is focusing on.
  • Patients who are not male or female cannot participate, as the study includes both male and female subjects.
  • Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.
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Investigated drugs

  • RVU120

    is a medication being studied for its potential to treat myelofibrosis, a type of bone marrow cancer. In this trial, RVU120 is being tested both on its own and in combination with another medication to see how well it works in reducing cancer activity.

  • Ruxolitinib

    is a medication that is already used to treat myelofibrosis. In this trial, it is being combined with RVU120 to determine if the combination is more effective than using RVU120 alone.

What is already known about the treatment

RVU120 – RVU120 is administered orally and is currently being studied in clinical trials for its potential use in treating myelofibrosis, a type of bone marrow cancer. It is being evaluated both as a standalone treatment and in combination with another medication called Ruxolitinib. RVU120 works by targeting specific proteins involved in cancer cell growth, aiming to slow down or stop the progression of the disease. It falls under the category of targeted cancer therapies, focusing on molecular pathways that are crucial for cancer cell survival.

Investigated diseases

Myelofibrosis – Myelofibrosis is a rare bone marrow disorder characterized by the replacement of bone marrow with fibrous tissue. This process disrupts the body's ability to produce blood cells, leading to anemia, weakness, and fatigue. As the disease progresses, the spleen and liver may enlarge due to the body's attempt to produce blood cells outside the bone marrow. Patients may experience symptoms such as night sweats, fever, and bone pain. Over time, myelofibrosis can lead to severe complications, including an increased risk of bleeding and infections. The condition can also transform into acute leukemia in some cases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511688-27-00Protocol codePOTAMI-61Estimated enrolment83 patientsSponsorRyvu Therapeutics S.A.

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