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Study of SEL120 Monohydrochloride for Treating Anemia in Patients with Lower-Risk Myelodysplastic Syndromes (MDS)

Verified siteInvestigationalNo 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 anemia in patients with a type of blood disorder known as myelodysplastic syndromes (MDS). These are disorders caused by poorly formed or dysfunctional blood cells. The study will use a treatment called RVU120, which is a small-molecule anticancer drug that works as a CDK8 kinase inhibitor. This drug is taken orally in the form of a capsule.

The purpose of the study is to evaluate how well RVU120 can help improve anemia in patients with lower-risk MDS. Participants in the study will receive the medication over a period of time, and their response to the treatment will be monitored. The study will look at how the drug affects the production of red blood cells and whether it can reduce the need for blood transfusions. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of RVU120.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to gather information on the safety and effectiveness of RVU120 in treating anemia associated with MDS. This research could potentially lead to new treatment options for patients with this condition.

The research process

The trial runs in 7 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 will begin by providing written informed consent. This is a necessary step before any study-related procedures can take place.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm the diagnosis of myelodysplastic neoplasms (MDS) and to ensure eligibility based on specific criteria, such as age and risk level of the disease.

  3. Step 3

    Medication administration

    The patient will receive the study medication, RVU120, which is administered orally in the form of capsules. The dosage is 150 mg per cycle.

  4. Step 4

    Treatment cycles

    The treatment consists of multiple cycles. Each cycle involves the administration of the medication and monitoring of the patient's response. The primary goal is to evaluate the erythroid response, which refers to the production of red blood cells.

  5. Step 5

    Monitoring and evaluation

    Throughout the study, the patient's health and response to the medication will be closely monitored. This includes regular blood tests to measure hemoglobin levels and assess the need for red blood cell transfusions.

  6. Step 6

    Completion of treatment

    After completing 8 full cycles of treatment, the patient's response will be evaluated according to specific criteria. The study aims to determine the effectiveness of the medication in improving anemia symptoms.

  7. Step 7

    End of study

    The study is estimated to conclude by May 2027. At the end of the study, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

13 criteria

  • You must provide written informed consent before any study-related procedures.
  • You must be at least 18 years old.
  • You must have a diagnosis of myelodysplastic neoplasms (MDS), which is a type of blood disorder, according to specific criteria.
  • Your MDS must be classified as very low, low, or intermediate risk, based on a scoring system used by doctors.
  • You must have symptomatic anemia, which means you have low red blood cell levels causing symptoms, documented in the 16 weeks before starting the study treatment.
  • There should be no available approved MDS therapy options for you, as decided by your doctor. This includes being exposed to certain treatments like ESA, luspatercept, or lenalidomide, or not being eligible for them.
  • You must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2, which is a scale used to assess how well you can perform daily activities.
  • You must have stopped any anti-cancer treatment for at least 2 weeks or 5 half-lives, whichever is longer.
  • Your laboratory test results must meet specific criteria, such as certain levels of white blood cells, platelets, and other blood components.
  • Your heart function must be adequate, confirmed by a test showing a left ventricular ejection fraction of at least 40%.
  • If you are male and sexually active with a female who can become pregnant, you must use an effective barrier method of contraception during the study and for 28 weeks after the last dose of the study drug. You must also not donate blood or sperm during this time.
  • The study investigator must consider you suitable for participation, meaning you understand the study requirements, can give informed consent, and can comply with study procedures.
  • You must have received all COVID-19 vaccinations according to national guidelines.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of anemia that is not related to very low, low, or intermediate risk myelodysplastic neoplasms (MDS) cannot participate.
  • Patients who do not meet the specific age range required for the study cannot participate.
  • Patients who are not part of the specific clinical trial group required for the study cannot participate.
  • Patients who are not able to give informed consent or are considered part of a vulnerable population may not be eligible.
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Investigated drugs

RVU120 is an oral medication being studied for its potential to treat anemia in patients with lower-risk myelodysplastic neoplasms (MDS). The goal of the trial is to see how well this medication can help improve the production of red blood cells in these patients.

What is already known about the treatment

RVU120 – This medication is administered orally and is currently being studied in a phase II clinical trial for its effectiveness in treating anemia in patients with lower-risk myelodysplastic neoplasms (MDS). It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for RVU120 is to improve anemia in these patients by evaluating the erythroid response. At the molecular level, RVU120 works by targeting specific pathways involved in blood cell production, aiming to enhance the production of red blood cells. It is classified pharmacologically as a potential treatment for blood disorders, specifically focusing on improving anemia associated with MDS.

Investigated diseases

Myelodysplastic Neoplasms (MDS) – Myelodysplastic neoplasms are a group of disorders caused by poorly formed or dysfunctional blood cells. These conditions occur when something goes wrong in the bone marrow, where blood cells are produced. Patients with MDS often experience anemia, which is a deficiency of red blood cells, leading to fatigue and weakness. The risk level of MDS can vary, with some patients having very low to intermediate risk. Over time, MDS can lead to a decrease in the number of healthy blood cells, causing symptoms like frequent infections or easy bruising. The progression of the disease can vary, with some cases remaining stable for years, while others may progress to more severe forms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509947-29-00Protocol codeREMARK_001Estimated enrolment45 patientsSponsorGcp-Service International West GmbH

sourced from the EU Clinical Trials Register and site verification

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