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Study on Long-Term Safety of Ruxolitinib, Panobinostat, and Siremadlin for Patients Continuing Treatment from Previous Studies

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 evaluating the long-term safety of treatments for patients who have previously participated in studies involving the medication ruxolitinib, either alone or in combination with other drugs. Ruxolitinib is a medication used to treat certain types of blood disorders. In this study, it may be combined with other medications such as panobinostat, siremadlin (also known as HDM201), or rineterkib. The purpose of the study is to gather information on the safety of these treatments over a longer period.

Participants in this study will continue their treatment with ruxolitinib or its combinations as they have been doing in their previous studies. The study will monitor the frequency and severity of any side effects or adverse events that occur during the treatment. This information will help researchers understand the long-term safety of these medications and their combinations.

The study is open-label, meaning that both the participants and the researchers know which treatment is being administered. It is conducted at multiple centers, allowing for a diverse group of participants. The study aims to provide valuable data on the safety of these treatments, which can benefit future patients who may receive these medications. Participants will be assessed regularly to determine any clinical benefits they may experience from the continued 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.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have completed a previous study involving ruxolitinib or its combinations with other medications such as panobinostat or siremadlin.

    The patient must be currently benefiting from the treatment as determined by the investigator.

  2. Step 2

    Medication administration

    The patient will continue to receive ruxolitinib or its combinations with panobinostat or siremadlin.

    All medications are administered orally in the form of capsules or tablets.

  3. Step 3

    Monitoring and evaluation

    The main objective is to evaluate long-term safety data, focusing on any serious adverse events (SAEs) or adverse events (AEs).

    The frequency and severity of these events will be monitored throughout the study.

  4. Step 4

    Scheduled visits

    The patient will attend scheduled visits where the investigator will assess the clinical benefits of the treatment.

    These assessments will help determine the proportion of patients experiencing clinical benefits.

  5. Step 5

    Study duration

    The study is expected to continue until September 16, 2027.

    The patient will remain in the study as long as they continue to benefit from the treatment and meet the study requirements.

Who can join the trial?

7 criteria

  • The patient must be currently enrolled in a study sponsored by Novartis or Incyte. This means they are already part of a research study organized by these companies.
  • The patient must be receiving treatment with a medicine called **ruxolitinib** alone or in combination with other medicines like **panobinostat**, **siremadlin**, or **rineterkib**. These are specific drugs used in the study.
  • The patient must have met all the requirements of the original study they are part of. This means they have followed all the rules and guidelines of the initial study.
  • The patient must be benefiting from the treatment they are receiving, as determined by the investigator. This means the doctor or researcher believes the treatment is helping the patient.
  • The study accepts both male and female patients.
  • The study includes patients from different age groups, including children, teenagers, and adults.
  • The study may include vulnerable populations, which means it might involve people who need special protection or care.

Who cannot join the trial?

5 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who do not meet the specific disease criteria outlined in the parent protocol.
  • Patients who are not part of the clinical trial group specified for this study.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Ruxolitinib

    is a medication used in this trial. It is typically used to treat certain types of blood disorders by helping to reduce symptoms such as enlarged spleen and other related issues. Patients who have previously participated in studies involving ruxolitinib and are benefiting from it may continue to receive this medication in the trial.

  • Panobinostat

    is another medication involved in the trial. It is often used in combination with other treatments to help manage certain types of cancer by slowing down or stopping the growth of cancer cells.

  • Siremadlin

    is included in the trial as well. This medication is being studied for its potential to treat cancer by targeting specific pathways that cancer cells use to grow and survive.

  • Rineterkib

    is also part of the trial. It is being investigated for its ability to treat cancer by interfering with the processes that allow cancer cells to multiply and spread.

What is already known about the treatment

  • Ruxolitinib

    Ruxolitinib is administered orally in tablet form. It is currently approved for use in certain blood disorders and is well-documented in medical literature. The main therapeutic indications include the treatment of myelofibrosis and polycythemia vera. At the molecular level, ruxolitinib works by inhibiting Janus kinase (JAK) enzymes, which play a role in the signaling pathways that control blood cell production. It is classified as a JAK inhibitor.

  • Panobinostat

    Panobinostat is taken orally as a capsule. It is approved for use in combination with other medications for the treatment of multiple myeloma and is recognized in medical literature. Its main therapeutic indication is for patients with multiple myeloma who have received prior treatments. Panobinostat works by inhibiting histone deacetylases, which leads to increased acetylation of histone proteins, affecting gene expression and cancer cell death. It is classified as a histone deacetylase inhibitor.

  • Siremadlin

    Siremadlin is administered orally in tablet form. It is currently under investigation in clinical trials and is not yet widely approved for use. The main therapeutic indication being explored is its potential in treating various cancers. Siremadlin works by inhibiting the MDM2 protein, which can lead to the activation of the p53 tumor suppressor pathway, promoting cancer cell death. It is classified as an MDM2 inhibitor.

  • Rineterkib

    Rineterkib is administered orally in tablet form. It is still in the clinical trial phase and not yet approved for general medical use. The main therapeutic indication under investigation is its use in treating certain types of cancer. Rineterkib functions by inhibiting specific signaling pathways involved in cancer cell growth and survival. It is classified as a kinase inhibitor.

Investigated diseases

  • Chronic Myeloid Leukemia

    This is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells. The disease progresses slowly and may not show symptoms initially. Over time, it can lead to fatigue, weight loss, and an increased risk of infections. As the disease advances, it may transform into a more aggressive form of leukemia. It is often associated with a specific genetic mutation known as the Philadelphia chromosome.

  • Multiple Myeloma

    This is a cancer of plasma cells, which are a type of white blood cell found in the bone marrow. It leads to the accumulation of abnormal plasma cells in the bone marrow, which can crowd out healthy blood cells. The disease can cause bone pain, frequent infections, and anemia. It may also result in kidney problems and high levels of calcium in the blood. The progression of multiple myeloma can vary, with periods of stability followed by more aggressive phases. It is often diagnosed through blood tests and bone marrow examinations.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515283-31-00Protocol codeCINC424A2X01BEstimated enrolment139 patientsSponsorNovartis Pharma Services AG

sourced from the EU Clinical Trials Register and site verification

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