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Study on RVU120 and Venetoclax for Patients with Acute Myeloid Leukemia After Previous Treatment Failure

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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 type of blood cancer called Acute Myeloid Leukemia (AML). The trial is testing a combination of two treatments: RVU120 and Venetoclax. Venetoclax is a medication that works by blocking a protein called BCL-2, which helps cancer cells survive. RVU120 is a new treatment being studied to see how well it works with Venetoclax in patients whose previous treatment with Venetoclax and another type of medication called a hypomethylating agent did not succeed.

The purpose of this study is to find the best dose of RVU120 when used with Venetoclax and to see how effective this combination is in treating AML. Participants in the study will take these medications by mouth in the form of tablets and capsules. The study will monitor the safety of the treatment and how the body processes the medications. It will also look at how well the treatment works in reducing the cancer.

Participants will be involved in the study for a period of time, during which they will receive the treatment and have regular check-ups to monitor their health and the effects of the treatment. The study aims to provide more information on the potential benefits of combining RVU120 with Venetoclax for patients with AML who have not responded to previous treatments.

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, informed consent is required. This means understanding the study's requirements and agreeing to participate.

    Eligibility is confirmed by checking health status, including blood tests and heart function. Women of childbearing potential must have a negative pregnancy test.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure recovery from previous treatments. This includes checking blood cell counts and liver and kidney function.

    Participants must not have received any other cancer treatment for at least 14 days before starting the study medication.

  3. Step 3

    Medication administration

    The study involves taking two medications: venetoclax and RVU120. Both are taken orally in capsule form.

    The dosage and frequency of these medications are determined during the study to find the most effective and safe dose.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes blood tests and other evaluations.

    The study aims to evaluate the response to the treatment, including any reduction in leukemia cells.

  5. Step 5

    Completion of study

    The study is expected to continue until February 2026. Participants will be monitored throughout the study period.

    Upon completion, participants will be evaluated for overall health and any long-term effects of the treatment.

Who can join the trial?

20 criteria

  • Provide written informed consent before any study-related procedure.
  • Recover from the side effects of previous treatments to at least a mild level, except for nerve-related side effects, which should improve to a moderate level or return to the original state, and hair loss.
  • Meet specific laboratory test results:
    • White blood cell count must be below a certain level on the first day of the study.
    • Platelet count must be above 10,000 per microliter at the start of the study.
    • Levels of liver enzymes (AST and ALT) should be no more than three times the normal limit.
    • Total bilirubin should be no more than three times the normal limit.
    • Kidney function, measured by creatinine clearance, should be at least 50 mL/min.
    • Have adequate heart function, confirmed by a test showing the heart pumps at least 40% of the blood in one beat.
    • For women who can have children, a negative pregnancy test is required before starting the study, and they must use effective birth control during the study and for about 6.5 months after the last dose. Men must use a barrier method of contraception if sexually active with a woman who can have children during the study and for about 6.5 months after the last dose.
    • Agree not to donate blood, eggs, or sperm during the study and for about 6.5 months after the last dose.
    • The study investigator must consider the participant suitable for the study, meaning they understand the study requirements, can follow the 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) according to the 2022 World Health Organization classification.
    • Have relapsed or refractory AML, meaning the disease has returned or not responded to treatment, as defined by specific criteria.
    • Have failed first-line treatment with Ven + HMA, which means not achieving certain levels of remission or the disease progressing after treatment.
    • No other treatment options are likely to provide clinical benefit.
    • Have an ECOG performance score of 0-2, which measures the ability to perform daily activities.
    • Have a life expectancy of at least 12 weeks.
    • Have not received any other anti-cancer treatment for 14 days or 5 half-lives, whichever is shorter, before the first dose of the study drug.

Who cannot join the trial?

6 criteria

  • Patients who have not been diagnosed with Acute Myeloid Leukemia (AML) cannot participate. AML is a type of cancer that affects the blood and bone marrow.
  • Patients who have not previously been treated with a combination of Venetoclax (Ven) and Hypomethylating Agents (HMA) are excluded. Venetoclax is a medication used to treat certain types of cancer, and hypomethylating agents are drugs that help to stop cancer cells from growing.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who do not belong to the specified clinical trial group are excluded. This means the study is looking for participants with specific characteristics or conditions.
  • Both male and female patients are eligible, but those who do not meet other criteria will be excluded.
  • Patients who are considered part of a vulnerable population, such as those who may not be able to give informed consent, are excluded to ensure their safety and well-being.
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Investigated drugs

  • RVU120

    is an investigational medication being studied for its potential to treat acute myeloid leukemia (AML). It is being tested in combination with another medication to see if it can help patients who have not responded to previous treatments. The study aims to find the right dose and to understand how well it works in fighting leukemia.

  • Venetoclax

    is a medication used to treat certain types of blood cancers, including AML. In this trial, it is combined with RVU120 to see if the combination can be more effective for patients who did not respond to previous treatments with Venetoclax and a hypomethylating agent. The goal is to improve the treatment outcomes for these patients.

What is already known about the treatment

  • RVU120

    This medication is administered orally and is currently being studied in clinical trials for its potential use in treating Acute Myeloid Leukemia (AML), particularly in patients who have not responded to previous treatments. RVU120 is being investigated for its ability to work in combination with Venetoclax, another medication, to enhance anti-leukemic effects. It is classified as a kinase inhibitor, which means it works by blocking specific enzymes that promote cancer cell growth. The goal of the ongoing research is to determine the optimal dose and assess its safety and effectiveness in combination therapy.

  • Venetoclax

    This medication is taken orally and is already approved for use in certain types of blood cancers, including Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia. In the context of the current clinical trial, Venetoclax is being combined with RVU120 to evaluate its effectiveness in patients with AML who have not responded to previous treatments. Venetoclax works by inhibiting a protein called BCL-2, which helps cancer cells survive, thereby promoting their death. It is classified as a BCL-2 inhibitor and is being studied further to enhance its therapeutic potential in combination with other drugs.

Investigated diseases

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. AML can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. The disease progresses quickly and requires prompt medical attention. It is more common in adults and can vary in its specific genetic mutations and characteristics. AML is considered a rare disease, and its progression can differ significantly among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505911-19-00Protocol codeRIVER-81Estimated enrolment191 patientsSponsorRyvu Therapeutics S.A.

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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.

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