A phase II, open-label, multicenter study of orally administered RVU120 for the treatment of anemia in patients with lower-risk myelodysplastic neoplasms (MDS)
This study is testing a new medicine called RVU120 for adults, 18 or older, who have a condition affecting their bone marrow called myelodysplastic neoplasms (MDS). Specifically, it's for those with lower-risk MDS who also suffer from anaemia (when your blood doesn't have enough healthy red blood cells). The main goal is to see if RVU120 can help the body produce more red blood cells and improve anaemia. Doctors will give the medicine by mouth and watch closely for eight cycles to see how patients respond. They'll also check for any side effects and how long any improvements in red blood cell count last. This is a Phase II study, which means it’s an earlier stage trial to find out if the treatment works and is safe.
At a glance
What is this study about?
This study is looking into a new treatment called RVU120 for people who have a condition named myelodysplastic neoplasms (MDS). MDS affects your bone marrow, which is the spongy tissue inside your bones that makes blood cells. In MDS, the bone marrow doesn't produce enough healthy blood cells, often leading to anaemia. Anaemia means you have a low number of red blood cells, which can make you feel very tired, weak, and short of breath.
The main aim of this study is to find out if RVU120 can help people with lower-risk MDS to produce more red blood cells and reduce their anaemia. The researchers will give RVU120 as a tablet by mouth over several months and closely monitor changes in blood counts. They are especially interested in seeing if the drug can help the body make enough healthy red blood cells on its own, potentially reducing the need for blood transfusions.
This is a 'Phase II' study. Clinical trials typically go through different phases. Phase II studies are usually smaller and focus on finding out if a new treatment works, how safe it is, and what the right dose might be. The information gathered from this study will help determine if RVU120 could be a useful new option for treating anaemia in people with lower-risk MDS.
Key takeaways
- This study is testing a new drug, RVU120, for anaemia in lower-risk MDS.
- The main goal is to see if RVU120 helps the body make more red blood cells.
- It's a Phase II study, looking at how well the drug works and its safety.
- Participation involves taking tablets and regular hospital visits for monitoring.
- Results could help improve treatment options for anaemia in MDS patients.
- You can stop participating at any time.
Who may be eligible?
To be able to join this study, people must be at least 18 years old. The study is open to both men and women.
Crucially, you would need to have been diagnosed with myelodysplastic neoplasms (MDS) that is considered 'lower-risk'. This means your MDS is classified by doctors as either very low risk, low risk, or intermediate risk. You must also be experiencing anaemia as a result of your MDS.
While the information provided doesn't list all the specific reasons someone might *not* be able to join, generally, studies like this often have other rules. For example, you might not be able to participate if you have other serious health problems, are taking certain medications that could interfere with the study drug, or if your MDS has progressed to a more advanced stage. Your doctor will be able to check all the specific requirements with you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I at least 18 years old?
- Do I have a diagnosis of myelodysplastic neoplasms (MDS)?
- Is my MDS considered 'lower-risk' (very low, low, or intermediate)?
- Do I currently experience anaemia related to my MDS?
What does participation involve?
If you decide to take part in this study, you would be given the study medication, RVU120, as a tablet to take by mouth. The study involves taking this medicine for a specific period, and you would likely have regular visits to the hospital or clinic. These visits are important for the study doctors to monitor your health, check for any side effects, and see how well the treatment is working.
During your visits, you can expect to have blood tests to check your red blood cell count and other blood cell levels. Doctors will also ask you how you are feeling and if you have noticed any changes. The main part of the treatment will last for 8 cycles (which means 8 periods of treatment), and during this time, they will especially be checking if your body starts making more red blood cells. The total duration of your participation, including follow-up, would be discussed by the study team.
Potential risks and benefits
Locations (5)
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedSpain
Common questions
What is anaemia?
Anaemia is a condition where your blood doesn't have enough healthy red blood cells, which carry oxygen around your body. It can make you feel tired and weak.
What are myelodysplastic neoplasms (MDS)?
MDS is a group of conditions where the bone marrow, the spongy tissue inside bones, doesn't produce enough healthy blood cells. It often leads to anaemia.
What is a 'Phase II' study?
A Phase II study is an early stage of clinical research. It mainly aims to find out if a new treatment works, how safe it is, and what a good dose might be.
Will I get blood transfusions if I need them during the study?
The study aims to reduce the need for transfusions. The doctors will monitor your blood counts closely and provide transfusions if medically necessary, as part of your care.
Is RVU120 a tablet or an injection?
RVU120 is described as being given "orally," which means it is taken by mouth, likely as a tablet or capsule.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.