Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study of RVU120 for Patients with Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia

Fast replyInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Featured sites

Sites that work closely with us on this trial

What is this trial about?

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

This clinical trial is focused on studying two serious blood disorders: Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS). These conditions affect the blood and bone marrow, leading to issues with blood cell production. The study is investigating a treatment called RVU120, which is a capsule taken orally. RVU120 contains an active chemical substance known as 7,8-dibromo-5,6-dihydro-9-methyl-2-(1-piperazinyl)-4H-imidazo[4,5,1-ij]quinoline hydrochloride. The purpose of the study is to estimate the anti-tumor activity of RVU120 when used alone.

Participants in the study will receive RVU120, and some may receive a placebo. The study will observe how the treatment affects the participants over a period of time. The trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study will help understand how effective RVU120 is in treating these blood disorders, especially in patients whose previous treatments have not been successful.

The trial will monitor various outcomes, such as the rate of complete response, overall response rate, and duration of response. It will also assess the safety of RVU120 by recording any side effects experienced by participants. The study aims to provide valuable information on whether RVU120 can be a beneficial treatment option for patients with relapsed or refractory AML or high-risk MDS, with or without specific genetic mutations like NPM1.

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, you will be required to provide written informed consent. This means you agree to participate after understanding the study's purpose and procedures.

    You will need to confirm your life expectancy is at least 12 weeks, and if you are a woman of childbearing potential, a negative pregnancy test is required before starting the study medication.

  2. Step 2

    Medication administration

    You will be taking a medication called SEL120 monohydrochloride in the form of a capsule. This medication is taken orally.

    The dosage, frequency, and duration of administration will be explained to you by the study team.

  3. Step 3

    Ongoing participation

    During the study, you will be required to use a highly effective method of contraception if you are of childbearing potential, and you must agree not to donate blood, eggs, or sperm.

    You will need to comply with all study-related procedures and evaluations as instructed by the study team.

  4. Step 4

    Monitoring and assessments

    Regular assessments will be conducted to monitor your health and the effects of the medication. This includes laboratory tests and other evaluations as necessary.

    You will be informed about the schedule and nature of these assessments.

  5. Step 5

    Completion of the study

    Upon completion of the study, you will be advised on any follow-up actions or additional care required.

    You will be informed about the results of the study and any implications for your health.

Who can join the trial?

20 criteria

  • Provide written informed consent before any study-related procedures.
  • Have a life expectancy of at least 12 weeks.
  • For women of childbearing potential (women who can become pregnant), a negative pregnancy test is required before starting the study. They must use a highly effective method of birth control during the study and for 28 weeks after the last dose of the study drug. For men, an effective barrier method of birth control must be used during the study and for 28 weeks after the last dose if they are sexually active with a woman who can become pregnant. Men should also advise their female partners to use highly effective birth control for the same period.
  • Agree not to donate blood, eggs, or sperm during the study and for 28 weeks after the last dose of the study drug.
  • The study investigator must consider the participant suitable for the study, meaning they understand the study requirements, can give informed consent, can follow the study medication and procedures, and are reliable and cooperative.
  • Have received all COVID-19 vaccinations according to national guidelines.
  • Be at least 18 years old at the time of giving informed consent.
  • Have a diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) as specified in the study criteria.
  • Have relapsed (the disease has returned) or refractory (the disease does not respond to treatment) AML or high-risk MDS.
  • Have failed at least one line of therapy and have no other available treatment options likely to provide benefit.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2, which measures the ability to perform daily activities.
  • Have not received any other anti-cancer treatment for 4 weeks or 5 half-lives, whichever is shorter, before the first dose of the study drug.
  • Must have recovered from the side effects of previous treatments to at least Grade 1, except for nerve damage (which should return to at least Grade 2 or baseline) or hair loss.
  • Meet specific laboratory test requirements, including:
    • White blood cell count must be less than 30 x 109/L on the first day of the study drug.
    • Platelet count must be greater than 10,000/μL (platelet infusion is allowed).
    • Serum albumin must be at least 25 g/L (2.5 g/dL).
    • Normal blood clotting tests (some elevation is acceptable).
    • Levels of liver enzymes AST and ALT must be no more than 3 times the upper limit of normal.
    • Total bilirubin must be no more than 3 times the upper limit of normal.
    • Creatinine clearance (a measure of kidney function) must be at least 30 mL/min.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not the focus of this study.
  • Patients who have had a heart attack or severe heart problems in the past 6 months.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that require treatment with antibiotics.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had an organ transplant.
  • Patients with a history of severe allergic reactions to medications.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse in the past 12 months.
  • Patients with severe liver or kidney disease.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

RVU120 is a medication being studied for its potential to treat certain types of blood cancers, specifically high-risk myelodysplastic syndrome and acute myeloid leukemia. These are conditions where the bone marrow does not produce enough healthy blood cells. RVU120 is being tested to see if it can help reduce or eliminate cancer cells in patients who have not responded to other treatments or whose cancer has returned. The trial is also looking at how well RVU120 works in patients with a specific genetic mutation known as NPM1. This medication is given on its own, without being combined with other cancer treatments, to see how effective it is by itself.

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 certain blood cancers. It is being investigated for its effectiveness in patients with Acute Myeloid Leukemia (AML) and high-risk Myelodysplastic Syndrome (MDS), particularly in cases where the disease has returned or is resistant to treatment. The medication works by targeting specific proteins in cancer cells, disrupting their growth and survival. RVU120 is classified as a targeted therapy, aiming to interfere with cancer cell processes at the molecular level.

Investigated diseases

  • Acute Myeloid Leukemia with or without NPM1 Mutation

    Acute Myeloid Leukemia (AML) is a type of cancer that starts in the blood-forming cells of the bone marrow and quickly progresses to affect the blood. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. The disease can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The presence or absence of the NPM1 mutation can influence the behavior of the leukemia cells. AML progresses rapidly and requires prompt medical attention to manage its effects on the body.

  • Relapsed or Refractory High-Risk Myelodysplastic Syndrome

    Myelodysplastic Syndrome (MDS) is a group of disorders caused by poorly formed or dysfunctional blood cells. In high-risk MDS, the bone marrow does not produce enough healthy blood cells, leading to anemia, infections, and bleeding problems. When MDS is relapsed, it means the disease has returned after treatment, and refractory MDS does not respond to standard treatments. The disease can progress to acute leukemia if not managed. High-risk MDS is characterized by a higher likelihood of progression and more severe symptoms compared to lower-risk forms.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505910-10-00Protocol codeRiver-52Estimated enrolment174 patientsSponsorRyvu Therapeutics S.A.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).