A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML) (VIALE-T)
This research trial, called VIALE-T, is for people in the UK with acute myeloid leukaemia (AML) who have recently had a stem cell transplant. AML is a type of blood cancer that affects the bone marrow. The study is testing two different medicines together, venetoclax and azacitidine. The main aim is to see if this combination is safe and helps people live longer and better after their transplant. Researchers will also look at how well the treatment prevents the cancer from coming back and how it affects their daily life and health. This is a Phase 3 study, meaning it's a key step in testing new treatments before they become widely available.
At a glance
What is this study about?
When someone has acute myeloid leukaemia (AML), it means their body is making abnormal white blood cells. A stem cell transplant is a powerful treatment for AML that replaces unhealthy blood cells with healthy ones. However, sometimes after a transplant, there's a risk the cancer might come back. This study, called VIALE-T, is looking for a way to reduce that risk and help people stay healthy longer.
This trial is testing two medicines, venetoclax and azacitidine, which work in different ways to fight cancer cells. Researchers want to understand if using these two medicines together after a stem cell transplant is a good and safe way to keep the AML from returning. They will compare this combination with other approaches to see which one works best.
The main goals of this study are to check how safe this combination of drugs is and whether it helps people live longer. The researchers will also carefully monitor other important things, like how well the treatment prevents the cancer from coming back, how it affects a person's quality of life, and whether it causes difficult side effects. This research is very important because it could lead to new and better ways to care for people with AML after their stem cell transplant.
Key takeaways
- Tests new drug combination (venetoclax + azacitidine) after stem cell transplant for AML.
- Aims to improve survival and prevent cancer return.
- Involves regular clinic visits and health assessments.
- Focuses on safety and quality of life.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adults who are 18 years old or older. You will be considered if you have acute myeloid leukaemia (AML).
Specifically, you need to have recently had an allogeneic stem cell transplant, which means you received stem cells from another person (a donor). The research team will review your medical history and test results to make sure this study is right for you and safe for your health.
There will be other detailed criteria that the study doctors will check to make sure the trial is a good fit. This might include recent blood test results or how well you recovered from your stem cell transplant. If you meet these criteria, you may be able to join.
- Are you 18 years old or older?
- Do you have Acute Myeloid Leukaemia (AML)?
- Have you recently had an allogeneic stem cell transplant?
- Are you able to attend regular clinic appointments and follow study instructions?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive either the combination of venetoclax and azacitidine, or another approved treatment, depending on which group you are assigned to. This is decided by chance, like flipping a coin. You will have regular visits to the clinic for medical check-ups, blood tests, and to make sure the treatment is working and you are not experiencing too many side effects. These visits will involve discussions about your health and how you are feeling, answering questionnaires about your quality of life, and physical examinations.
The study will also involve detailed monitoring of your health over time, including looking for any signs of the cancer coming back or any complications from the treatment or your transplant. The total duration of your participation, including treatment and follow-up, will be explained by the study team, but it will involve ongoing assessments for a period after the main treatment phase.
Potential risks and benefits
Locations (7)
- —Czechia
- —Hungary
- —Spain
- —Italy
- —Germany
- —Greece
- —France
Common questions
What is AML?
AML stands for Acute Myeloid Leukaemia, which is a fast-growing cancer of the blood and bone marrow.
What is a stem cell transplant?
A stem cell transplant is a medical procedure that replaces unhealthy blood-forming cells in your bone marrow with healthy ones, often from a donor.
What are venetoclax and azacitidine?
These are two different medicines used to treat certain types of blood cancers. This study explores using them together.
What does 'Phase 3' mean for a study?
Phase 3 means the treatment has already shown promise in earlier studies, and now researchers are testing it on a larger group of people to confirm its safety and effectiveness compared to existing treatments.
Will I have to pay to be part of the study?
No, you will not have to pay for the study treatments or any study-related tests. These costs are covered by the research.
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.