Study of RVU120 and Ruxolitinib for Patients with Intermediate or High-Risk Myelofibrosis

2 1 1 1 1

What is this study about?

This clinical trial is focused on studying a condition called Myelofibrosis, which is a type of blood cancer that affects the bone marrow. The trial will test a new investigational drug called RVU120, both on its own and in combination with another medication known as Ruxolitinib (also referred to by its code name, INCB018424). The purpose of the study is to evaluate the effectiveness of RVU120 in treating myelofibrosis, either alone or when used together with Ruxolitinib.

Participants in the study will receive either RVU120 or a combination of RVU120 and Ruxolitinib. The study will last for a period of up to 24 months. During this time, participants will be monitored to see how their condition responds to the treatment. The study will involve regular check-ups and assessments, including imaging tests like MRI or CT scans, to measure changes in the size of the spleen, which is often enlarged in myelofibrosis. The study will also look at other factors such as symptom improvement and overall health outcomes.

Throughout the trial, the safety and side effects of the treatments will be closely observed. Participants will be asked to report any changes in their symptoms or any new symptoms they experience. The trial aims to provide valuable information on the potential benefits and risks of using RVU120, alone or with Ruxolitinib, for treating myelofibrosis. This research could lead to new treatment options for patients with this condition.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose and procedures. The participant will provide informed consent, confirming understanding and agreement to participate in the study.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes evaluating liver and kidney function, blood counts, and overall health status. A pregnancy test will be conducted for women of childbearing potential.

3 treatment phase

The participant will receive the investigational drug RVU120 either alone or in combination with ruxolitinib. The specific treatment regimen will depend on the participant’s cohort assignment.

For those receiving ruxolitinib, the medication will be administered orally in tablet form. Dosages may include Jakavi 5 mg, 15 mg, or 20 mg tablets, taken as prescribed by the study team.

Participants may also receive SEL120 monohydrochloride in capsule form, taken orally as directed.

4 monitoring and follow-up

Regular monitoring will occur throughout the study to assess the participant’s response to treatment and any side effects. This includes imaging tests like MRI or CT scans to measure spleen size and blood tests to monitor health status.

Participants will be evaluated for symptom improvement and any changes in their condition. The study team will track the duration of spleen response and any potential progression of the disease.

5 end of treatment

After completing the treatment phase, participants will undergo a final assessment to evaluate the overall impact of the treatment. This includes measuring any changes in spleen size, symptom scores, and overall health.

6 post-study follow-up

Participants will be monitored for a period after the study to observe any long-term effects of the treatment. This includes regular health check-ups and assessments as needed.

Who Can Join the Study?

Must be at least 18 years old at the time of giving consent to participate.
Must have proper liver function, which means certain liver enzymes and bilirubin levels should be within specific limits.
If a woman can have children, she must have a negative pregnancy test before starting the study and use a reliable method of birth control during the study and for about 6.5 months after the last dose. Men must use a barrier method of birth control if they are sexually active with a woman who can have children, and their partners should also use effective birth control for the same period.
Must agree not to donate blood, eggs, or sperm during the study and for about 6.5 months after the last dose.
The study doctor must believe the participant is suitable for the study, understands what is required, can follow the study rules, and is reliable and cooperative.
Must have a diagnosis of primary or secondary myelofibrosis (MF), a type of blood cancer, according to specific medical criteria.
Must have intermediate or high-risk disease according to a specific scoring system for MF.
For certain groups in the study, participants must have specific responses or lack of response to previous treatments with JAK inhibitors, a type of medication used for MF.
Must have a measurable enlarged spleen, which can be felt or measured by imaging tests like MRI or CT.
Must have active symptoms of MF, such as night sweats, itchiness, abdominal discomfort, pain under ribs on the left side, feeling full quickly, bone or muscle pain, and inactivity, with specific scores on a symptom scale.
Must have an ECOG performance score of 0-2, which measures the ability to perform daily activities.
Must have proper blood function, meaning certain blood cell counts should be within specific limits.
Must have proper kidney function, which means a certain level of creatinine clearance, a measure of kidney health, should be met.

Who Cannot Join the Study?

Patients who have a different type of cancer than myelofibrosis cannot participate. Myelofibrosis is a type of blood cancer that affects the bone marrow.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are not part of the specified clinical trial group cannot participate. Clinical trial groups are categories of patients that the study is focusing on.
Patients who are not male or female cannot participate, as the study includes both male and female subjects.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
M2m Med. Sp. z o.o.	Chorzow	Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
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
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.	Meldola	Italy
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Lux Med Onkologia Sp. z o.o.	Warsaw	Poland
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Uniwersyteckie Centrum Kliniczne	Gdansk	Poland
Universita Degli Studi Di Brescia	Brescia	Italy
Show more
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
Aoekxst Scz z ojvw	Poznan	Poland

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	27.08.2024
Poland	Not recruiting	27.08.2024

Trial locations

Investigated drugs:

RVU120 is a medication being studied for its potential to treat myelofibrosis, a type of bone marrow cancer. In this trial, RVU120 is being tested both on its own and in combination with another medication to see how well it works in reducing cancer activity.

Ruxolitinib is a medication that is already used to treat myelofibrosis. In this trial, it is being combined with RVU120 to determine if the combination is more effective than using RVU120 alone.

Investigated diseases:

Myelofibrosis

Myelofibrosis – Myelofibrosis is a rare bone marrow disorder characterized by the replacement of bone marrow with fibrous tissue. This process disrupts the body’s ability to produce blood cells, leading to anemia, weakness, and fatigue. As the disease progresses, the spleen and liver may enlarge due to the body’s attempt to produce blood cells outside the bone marrow. Patients may experience symptoms such as night sweats, fever, and bone pain. Over time, myelofibrosis can lead to severe complications, including an increased risk of bleeding and infections. The condition can also transform into acute leukemia in some cases.

Trial ID:

2024-511688-27-00

Protocol code:

POTAMI-61

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of RVU120 and Ruxolitinib for Patients with Intermediate or High-Risk Myelofibrosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?