RVU120 for Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms
This study is looking into a new tablet called RVU120 for individuals aged 18 and over who have a type of blood disorder called lower-risk myelodysplastic syndrome (MDS) and are experiencing anaemia (low red blood cell count). RVU120 works in a new way to help your body produce more red blood cells. We want to find out how well it helps improve anaemia and if it is safe for patients. Some participants might have already tried other treatments that didn't work for them, while others may not be able to take those treatments. If the drug helps, you could continue taking it as long as it's still working and you're not experiencing any problems.
At a glance
What is this study about?
This study is about a new medication called RVU120, which is being tested for people with a blood disorder called myelodysplastic syndrome (MDS). MDS affects how your body makes healthy blood cells, and in this study, we're focusing on people with a 'lower-risk' type of MDS who have anaemia. Anaemia means you don't have enough red blood cells, which can make you feel very tired and short of breath.
The main goal of this study is to see if RVU120 can help improve anaemia in people with lower-risk MDS. We also want to understand if the medication is safe and what side effects it might cause. RVU120 is a new type of drug that works differently from existing treatments. It's designed to help your bone marrow, which is the spongy tissue inside your bones, produce more healthy red blood cells.
Finding new ways to treat anaemia in MDS patients is important because current treatments don't work for everyone, or they might cause side effects. If RVU120 proves to be effective and safe, it could offer another option to help people with lower-risk MDS feel better and improve their quality of life.
Key takeaways
- This study is for people with lower-risk MDS and anaemia.
- It's testing a new tablet called RVU120 to see if it improves red blood cell counts.
- Participation involves taking the drug and having regular check-ups.
- It's an option for those for whom other treatments haven't worked or aren't suitable.
- We need to check if RVU120 is safe and effective.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old and have a confirmed diagnosis of de novo myelodysplastic syndrome (MDS). Your MDS should be classified as very low, low, or intermediate risk according to a specific scoring system. This includes patients with certain genetic changes like 'del(5q)', but not some other specific changes.
You also need to be experiencing anaemia that is causing symptoms. This means either your haemoglobin (Hb) levels (a measure of red blood cells) are consistently low, or you've needed regular red blood cell transfusions in the past few months. Before joining, we'd confirm that your medical records show consistent anaemia.
Crucially, you would also be considered if other standard MDS treatments haven't worked for you, or if they aren't suitable for you. For example, if treatments like ESAs (Erythropoiesis-stimulating agents), Luspatercept, or Lenalidomide either didn't help, caused problems, or you couldn't take them for other reasons.
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.
- Are you 18 years old or older?
- Do you have a confirmed diagnosis of MDS (not a more aggressive type)?
- Are you experiencing symptoms of anaemia (e.g., needing transfusions or having low blood counts)?
- Have other common anaemia treatments for MDS either not worked for you, or were they not an option?
- Do you feel physically well enough to take part in a study?
- Would you be able to attend regular clinic visits?
What does participation involve?
If you join this study, you will be taking RVU120 by mouth. You will have regular visits to the clinic for check-ups, blood tests, and to monitor your health. These visits will help us see how the medication is working and if you are having any side effects. The study will involve a screening period to confirm you meet all the requirements, and then you would start on the RVU120. If the treatment helps you, you could continue taking it as long as it remains beneficial and you are not experiencing any significant problems. The total duration of your participation could vary depending on how you respond to the treatment.
Potential risks and benefits
Locations (25)
- CHU Grenoble Alpes - Hôpital MichallonVerified postcodeGrenoble, France
- CHU de Nice - Hôpital l'Archet 1Verified postcodeNice, France
- Hôpital Saint-Louis, Service d'Hématologie SéniorsVerified postcodeParis, France
- CHU de Bordeaux - Centre François Magendie - Groupe Hospitalier SudVerified postcodePessac, France
- CHU de Toulouse - Institut Universitaire du Cancer de Toulouse - OncopoleVerified postcodeToulouse, France
- Marien Hospital DüsseldorfVerified postcodeDüsseldorf, Germany
- Universität Leipzig, Med. Fak., Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und InfektiologieVerified postcodeLeipzig, Germany
- Universitätsklinikum Münster (UKM)Verified postcodeMünster, Germany
- AOU delle MarcheVerified postcodeAncona, Italy
- AOU Consorziale Policlinico, Università degli Studi Aldo MoroVerified postcodeBari, Italy
- Candiolo Cancer Institute, IRCCS Fondazione del Piemonte per l'OncologiaVerified postcodeCandiolo, Italy
- AOU CareggiVerified postcodeFlorence, Italy
Common questions
What is myelodysplastic syndrome (MDS)?
MDS is a type of blood cancer where your bone marrow doesn't produce enough healthy blood cells. It can lead to problems like anaemia.
What does 'lower-risk' MDS mean?
Lower-risk MDS means the condition is generally less aggressive and progresses more slowly, but it can still cause symptoms like severe anaemia.
What is anaemia?
Anaemia means you have a low number of red blood cells, which carry oxygen around your body. It can make you feel tired, weak, and short of breath.
What is RVU120?
RVU120 is a new experimental drug in tablet form that aims to help your body make more red blood cells by targeting specific proteins in your cells.
Can I still take part if I've tried other anaemia treatments?
Yes, if other treatments for your anaemia (like ESAs or Luspatercept) haven't worked or weren't suitable for you, you may still be eligible for this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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