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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Centre Hospitalier Universitaire De Lille	Lille	France
Hospital Universitario De Navarra	Pamplona	Spain
CHU Grenoble Alpes	La Tronche	France
IRCCS Humanitas Research Hospital	Rozzano	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.	Meldola	Italy
Centre Hospitalier Universitaire De Nimes	Nimes	France
Hospital Del Mar	Barcelona	Spain
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Hospital San Pedro De Alcantara	Caceres	Spain
MD Anderson Cancer Center	Madrid	Spain
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Poland
Szpital Uniwersytecki Imienia Karola Marcinkowskiego W Zielonej Gorze Sp. z o. o.	Zielona Gora	Poland
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii	Wroclaw	Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Centre Henri Becquerel	Rouen	France
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Centre Hospitalier Le Mans	Le Mans	France
Universita’ Politecnica Delle Marche	Ancona	Italy
Azienda Ospedaliera Universitaria Citta’ Della Salute E Della Scienza Di Torino	Turin	Italy
Centre Hospitalier Universitaire De Nice	Nice	France
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Uniwersyteckie Centrum Kliniczne	Gdansk	Poland
Hospital De La Santa Creu I Sant Pau	Barcelona	Spain
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz	Madrid	Spain
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Institut Paoli-Calmettes Cancer Centre	Marseille	France
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Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego	Walbrzych	Poland
IRCCS Azienda Ospedaliero Universitaria – Policlinico di Sant’Orsola	Bologna	Italy

Trial status

Country	Status	Recruitment Start
France	Recruiting	12.12.2023
Italy	Recruiting	12.12.2023
Poland	Recruiting	12.12.2023
Spain	Recruiting	12.12.2023

Trial locations

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.

Investigated diseases:

Acute myeloid leukaemia

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 ID:

2023-505911-19-00

Protocol code:

RIVER-81

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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