Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
This study, called VIALE-M, is for people who have recently been treated for a type of blood cancer called acute myeloid leukemia (AML) and are now in 'first remission'. This means their cancer is currently under control after their initial treatment. The study is investigating two medicines, venetoclax and azacitidine, used together as a 'maintenance' treatment. Maintenance treatment aims to help keep the cancer from coming back for as long as possible. Researchers are particularly interested in understanding any side effects these medicines might cause when used in combination, to make sure the doses are safe and effective. It's a Phase 3 study, which means it's a critical stage before a treatment can become widely available.
At a glance
What is this study about?
This research is focused on a specific type of blood cancer called Acute Myeloid Leukemia (AML). People who join this study will have recently completed their first round of standard chemotherapy treatment for AML and are now in what doctors call 'first remission'. This is a really positive step, as it means their cancer levels are very low, or undetectable, at present.
The main goal of this study is to see if combining two drugs, venetoclax and azacitidine, as a 'maintenance' treatment can help keep the AML from returning. Think of maintenance treatment like a regular check-up or a long-term plan to keep you well after a major illness. Researchers want to understand how safe this combination of drugs is and what side effects people might experience, especially when deciding on the right amount (dose) of the medicines to give.
Because this is a Phase 3 study, it means the drugs have already shown some promise in earlier research. This stage is crucial for confirming if the treatment is effective and safe enough to potentially be used more widely in the future. The information gathered will help doctors and patients make informed decisions about the best ways to manage AML after initial treatment.
Key takeaways
- This study is for adults with a type of blood cancer called AML.
- Patients must be in 'first remission' after initial chemotherapy.
- It's testing a combination of two maintenance drugs: venetoclax and azacitidine.
- The main goal is to find safe doses and understand any side effects.
- This is a Phase 3 study, a crucial step before new treatments become widely available.
- Participation could offer access to new treatments and help medical research.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. There's no upper age limit, which means people of all adult ages can potentially take part. Both men and women are welcome to participate.
The most important medical requirement is that you must have been diagnosed with Acute Myeloid Leukemia (AML) and have recently finished your first course of standard chemotherapy. Crucially, your AML needs to be in 'first remission'. This means your doctors have confirmed that your cancer is currently under control after that initial treatment.
This study is looking for patients who fit these specific criteria because the researchers want to understand how the new treatment affects people at this particular stage of their AML journey. Your doctor will carefully check all your medical information 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?
- Have you been diagnosed with Acute Myeloid Leukemia (AML)?
- Have you completed your first main course of chemotherapy for AML?
- Has your doctor confirmed that your AML is currently in 'first remission' (under control)?
What does participation involve?
If you decide to take part, the study will involve taking two new medicines, venetoclax and azacitidine. The main focus at this stage of the study was finding the right amount (dose) of venetoclax to combine safely with azacitidine. This meant closely watching for any side effects people experienced to make sure the doses were safe.
The study would involve regular visits to the hospital or clinic. During these visits, the medical team would perform various checks, such as blood tests, physical examinations, and asking about how you are feeling. These assessments are important to track your health, monitor the effects of the medicines, and look out for any side effects. The total duration of your participation would depend on how your treatment progresses, and you would be given a clear schedule by the study team.
Potential risks and benefits
Locations (7)
- —UnverifiedGermany
- —UnverifiedGreece
- —UnverifiedCzechia
- —UnverifiedHungary
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What is 'Acute Myeloid Leukemia in First Remission'?
It means you have a type of blood cancer called AML, and your first treatment has been successful in getting the cancer under control – it's not currently detectable.
What does a 'Phase 3 study' mean?
This is a key stage of research where doctors confirm if a new treatment is safe and works better than existing options, often involving many patients worldwide.
What are venetoclax and azacitidine?
These are two types of medicines used to treat certain cancers. This study is looking at using them together as a 'maintenance' treatment for AML.
What is 'maintenance therapy'?
It's a treatment given after the main treatment has worked, with the aim of preventing the cancer from coming back for as long as possible.
Will I have to pay to be part of the study?
No, you will not have to pay for the study treatments or related medical care if you take part in a clinical trial.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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