Study of RVU120 treatment in patients with myelodysplastic syndrome, solid tumors, or acute myeloid leukemia who benefited from previous RVU120 therapy

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What is this study about?

This clinical trial studies the continued use of RVU120 (also known as SEL120) in patients with several types of cancer including Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, and advanced or spreading solid tumors that have either come back or did not respond to previous treatments. The purpose of this study is to provide ongoing access to RVU120 treatment for patients who have already been taking this medication in previous studies and are experiencing benefits from it.

The medication being studied, RVU120, comes in the form of capsules that are taken by mouth. The treatment can be given either alone or combined with other medications, depending on how the patient was treated in their previous study. The maximum daily amount that can be given is 150 milligrams, and treatment may continue for up to 5 months.

During the study, doctors will monitor how well patients tolerate the medication by checking for any side effects or health problems that may occur. The study will track how long patients can continue taking the medication before they need to stop treatment for any reason. This helps researchers understand both the long-term safety and effectiveness of RVU120 in treating these types of cancer.

1 Initial treatment continuation

You will continue receiving RVU120 treatment in the same way as in your previous study, either alone or in combination with other medications

The treatment will be given in the form of oral capsules

Your treatment will continue for as long as you are experiencing benefits from it

2 Regular health monitoring

Your health status will be regularly monitored to track any side effects

The medical team will record any adverse events or serious health issues that may occur during treatment

Regular assessments will determine if you continue to benefit from the treatment

3 Treatment cycles

The treatment will be organized in cycles, continuing the same schedule as in your previous study

You must have completed at least 5 cycles in the previous study to participate in this continuation

4 Safety requirements

You should not donate blood during the study and for 28 weeks after your last dose

You must follow specific safety guidelines regarding pregnancy prevention throughout the study and for 28 weeks after the last dose

Regular pregnancy tests will be required for female participants who can become pregnant

5 Study completion

The study is planned to continue until June 2026

Treatment may be discontinued if you no longer benefit from it or if safety concerns arise

After stopping treatment, you will need to follow safety guidelines for 28 weeks

Who Can Join the Study?

Must be currently enrolled in a RVU120 clinical study and receiving treatment for at least 5 cycles
Must be showing benefit from the current treatment and expected to continue benefiting according to doctor’s assessment
Must not have access to other suitable cancer treatments, or if available, they must not be appropriate for the patient
For female participants:
- Must not be pregnant or breastfeeding
- Must use highly effective contraception during the study and for 28 weeks after the last dose
- Must have a negative pregnancy test within 3 days before starting treatment
For male participants:
- Must agree not to donate sperm during the study and for 28 weeks after the last dose
- Must either remain abstinent or use condoms during the study and for 28 weeks after the last dose
Must sign the informed consent form before starting any study procedures
Must agree not to donate blood during the study and for 28 weeks after the last dose
Must be able to:
- Understand and follow study requirements
- Comply with treatment schedule
- Cooperate with all study procedures

Who Cannot Join the Study?

Currently experiencing serious side effects from previous treatments that have not resolved
Unable to give informed consent or understand study requirements due to mental or physical conditions
Have severe heart conditions (such as uncontrolled high blood pressure, recent heart attack, or severe heart rhythm problems)
Have active infections that require treatment
Pregnant women or women who are breastfeeding
Have other types of cancer that are currently active or requiring treatment
Have severe liver problems (liver function tests more than 3 times the normal limit)
Have severe kidney problems (poor kidney function requiring dialysis)
Taking medications that could interact with the study drug
Participating in other clinical trials within the past 30 days
History of allergic reactions to similar medications
Have conditions that could interfere with taking oral medications
Unable to follow study procedures or attend required study visits
Have any condition that the study doctor believes would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
M2m Med. Sp. z o.o.	Chorzow	Poland
Hospital Universitario De Navarra	Pamplona	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Centre Hospitalier Universitaire De Nice	Nice	France
University Hospital Consorziale Policlinico	Bari	Italy
Upbzccethtfkvj Cyjaplh Kdjpkfhfi	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
France	Recruiting	07.08.2025
Italy	Not yet recruiting	07.08.2025
Poland	Recruiting	07.08.2025
Spain	Not yet recruiting	07.08.2025

Trial locations

Investigated drugs:

RVU120 is an investigational medication being studied for continued treatment in patients who have previously shown benefits from it in earlier clinical trials. It is being evaluated both as a standalone treatment and in combination with other therapies. This medication is still in the research phase, and this study aims to provide ongoing access to patients who have responded well to the treatment while monitoring its long-term safety.

Investigated diseases:

Myelodysplastic Syndrome – A group of blood disorders where blood cells in the bone marrow do not mature properly and remain immature. The condition affects the normal production of blood cells, leading to decreased numbers of one or more types of blood cells. The bone marrow produces abnormal blood cells that fail to function correctly.

Metastatic Solid Tumors – A condition where cancer cells spread from their original location to other parts of the body, forming new tumors. These secondary tumors grow in organs or tissues distant from the primary cancer site. The cancer cells travel through the bloodstream or lymphatic system to reach other areas.

Acute Myeloid Leukemia – A blood cancer that starts in the bone marrow, where immature blood cells develop abnormally and multiply rapidly. These abnormal cells build up in the bone marrow and interfere with the production of normal blood cells. The condition develops quickly, with abnormal white blood cells accumulating and crowding out healthy cells.

Trial ID:

2025-521673-14-00

Protocol code:

ROVER-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of RVU120 treatment in patients with myelodysplastic syndrome, solid tumors, or acute myeloid leukemia who benefited from previous RVU120 therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?