Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML
This study is a clinical trial investigating a new drug called RVU120 for adults diagnosed with acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome (MDS). These are types of blood cancers. The study is for people whose cancer has either returned after treatment or hasn't responded well to standard therapies, and who don't have other treatment options. The main goals are to find out if RVU120 is safe, what side effects it might cause, and how well it works to control or shrink the cancer. It's a two-part study; the first part focuses on safety and finding the right dose, and the second part will test the drug in more people once safety is established.
At a glance
What is this study about?
This study is looking into a new medication called RVU120. It's being tested for adults who have specific types of blood cancers: acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome (MDS). These are serious conditions, and this trial is specifically for people whose cancer has either come back after treatment or isn't getting better with the usual therapies. The research aims to understand if RVU120 can be a safe and effective treatment option when other treatments haven't worked.
The study has two main parts. The first part will focus on safety. Researchers will carefully check for any side effects and how well patients tolerate the drug. They'll also start to get an idea of whether the drug has any positive effects on the cancer. Once they have a good understanding of the drug's safety and how patients respond, they'll move to the second part of the study. This part will involve more patients to learn more about RVU120's safety and how well it works to fight the cancer in a larger group.
Finding new treatments for these types of blood cancers is very important, especially for those whose disease is advanced or has not responded to existing options. This trial is a step towards potentially offering another choice to patients in this challenging situation.
Key takeaways
- This study tests a new drug, RVU120, for certain types of AML or high-risk MDS.
- It's for adults whose cancer has returned or isn't responding to standard treatments.
- The main goals are to check the drug's safety and if it helps fight cancer.
- Participation involves regular clinic visits and a year of follow-up.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be an adult (18 or older) with a diagnosis of acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome (MDS). Your cancer must have returned or continued to worsen even after previous treatments, and there shouldn't be any other standard treatments left that are likely to help you. Your overall health and fitness, as assessed by a doctor, must also be good enough to take part in a clinical trial. This includes having certain blood test results and organ functions within a healthy range.
There are also some reasons why you might not be able to join. For example, if you have certain active infections, a specific type of AML called APL, or if you've recently had major surgery or a stem cell transplant. You also can't have received previous treatment with a similar type of drug. If your cancer has spread to your brain or spinal cord, you would also not be able to participate. The study team will review all your medical information carefully to see if this study is suitable for 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.
- Are you 18 years old or older?
- Do you have a diagnosis of AML or high-risk MDS?
- Has your cancer come back or not responded to previous treatments?
- Are you generally well enough to participate in a clinical trial?
- Have you NOT had a stem cell transplant in the last 4 months (120 days)?
What does participation involve?
If you decide to join this study, you'll first have a `Screening Period` that can last up to three weeks. During this time, you'll have tests and checks to make sure you meet all the study requirements. After screening, you will enter the `Treatment Period`. You will take the study drug, RVU120, as a tablet every other day, for 7 doses within a 13-day period. This 13-day period is part of a 21-day cycle, which means you'll have some days off the drug within each cycle. You'll continue taking RVU120 for as long as it's helping you and you're not experiencing severe side effects, or until you are eligible for a transplant.
Throughout the study, you'll have regular visits to the hospital for check-ups, blood tests, and to make sure the treatment is safe and working well. After you finish taking the study drug, there will be an `End of Treatment` period of about 30 days for final assessments. Following this, you'll enter a `Follow-up Period` which lasts for about one year. During this time, the study team will contact you every three months, usually by phone, to check on your health and see how you are doing. You are free to withdraw from the study at any time, for any reason.
Potential risks and benefits
Locations (41)
- Centre Hospitalier Universitaire Grenoble AlpesVerified postcodeLa Tronche, France
- Centre Hospitalier Le MansVerified postcodeLe Mans, France
- Centre Hospitalier Universitaire de Lille (CHU Lille)Verified postcodeLille, France
- Institut Paoli Calmettes (IPC)Verified postcodeMarseille, France
- Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet IVerified postcodeNice, France
- Centre Hospitalier Universitaire de Nimes (CHU) - Institut de Cancerologie du GardVerified postcodeNîmes, France
- Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-LouisVerified postcodeParis, France
- UNICANCER - Centre Henri-BecquerelVerified postcodeRouen, France
- Azienda Ospedaliero Universitaria Delle MarcheVerified postcodeAncona, Italy
- Univerisity of Bologna Policlinico Sant'OrsolaVerified postcodeBologna, Italy
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di BresciaVerified postcodeBrescia, Italy
- Careggi University HospitalVerified postcodeFlorence, Italy
Common questions
What is AML and MDS?
AML (Acute Myeloid Leukaemia) and MDS (Myelodysplastic Syndrome) are types of cancer that affect the blood and bone marrow, which is where blood cells are made. In these conditions, the body doesn't produce healthy blood cells properly.
What does 'relapsed or refractory' mean?
It means your cancer has either come back after it was successfully treated, or it hasn't responded to previous treatments and is continuing to get worse.
What is RVU120?
RVU120 is the new experimental drug being investigated in this clinical trial. It's designed to target specific pathways involved in cancer growth, but it's still in the testing phase.
How long will I be on the study drug?
You'll continue to take the study drug for as long as it's helping you, you're tolerating it well, or until you become eligible for a transplant. The overall follow-up will last about a year after you finish the drug.
Can I stop participating in the study?
Yes, you can choose to leave the study at any time, for any reason, without affecting your standard medical care or relationship with your doctor.
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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