An open-label, single-arm, pilot study of Venetoclax in combination with 5 days Azacitidine in treatment-naïve subjects with acute myelogenous leukemia who are ≥18 years of age and not eligible for standard induction therapy (VENAZA-5S PILOT TRIAL)
This study is for adults, aged 18 and over, who have a type of blood cancer called acute myeloid leukaemia (AML) and are unable to receive the usual strong initial treatments. We are testing a new combination of two existing medicines: Venclyxto (venetoclax) and Vidaza (azacitidine). This is an early-stage study to understand how well this combination works. We will be looking at how many patients show a significant improvement in their cancer after treatment, specifically if their leukaemia goes into what's called a 'complete remission' or 'complete remission with incomplete blood count recovery'. The study aims to gather important information that could help improve future treatments for AML.
At a glance
What is this study about?
This study is looking into a new way to treat acute myeloid leukaemia, often shortened to AML. AML is a type of blood cancer that affects your white blood cells. This particular study focuses on adult patients who are 18 years or older and, for various reasons, cannot have the standard strong initial treatments usually given for AML. Because these standard treatments might not be suitable for everyone, it's important to explore other options.
The study combines two medicines that are already available: Venclyxto (also known as venetoclax) and Vidaza (also known as azacitidine). Researchers want to see how effective this combination is when given together. The main goal is to find out how many patients experience a significant improvement in their leukaemia, specifically measuring if their cancer goes into remission after receiving up to six cycles of this treatment. Remission means that signs of the cancer have mostly or completely disappeared.
By gathering this information, researchers hope to learn if this new combination could become a useful treatment option for people with AML who are not able to have standard therapy. This type of study is an important step in medical research, helping us to better understand and develop treatments for serious conditions like AML.
Key takeaways
- This study is for adults with AML who can't receive standard initial treatment.
- It combines two existing medicines, Venclyxto and Vidaza.
- The main goal is to see how well this combination works to achieve remission.
- Participation involves regular clinic visits, blood tests, and taking study medication.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
This study is for adults aged 18 years or older. You could be considered for this study if you have acute myeloid leukaemia (AML).
A key requirement is that you must not be suitable for the usual strong initial treatments that are typically given for AML. Your doctor will be able to tell you if this applies to you, based on your overall health and other medical conditions.
Both men and women can take part in this study. There are no upper age limits, so if you are an older adult who meets the other criteria, you may still be eligible.
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.
- I am 18 years old or older.
- I have been diagnosed with acute myeloid leukaemia (AML).
- My doctor has told me that I'm not suitable for the usual strong first-line treatments for AML.
- I am willing and able to attend regular clinic appointments and take study medication.
What does participation involve?
If you decide to take part, you will receive two study medicines: Venclyxto tablets and Vidaza injections. The Vidaza will be given as an injection, and the Venclyxto will be taken as tablets. We expect you will receive up to 6 cycles of this treatment. Each cycle involves a specific schedule of medication.
Throughout the study, you will have regular visits to the clinic. These visits will involve various tests, such as blood samples, to monitor your health and how the treatment is working. We will also ask about any side effects you might experience and how you are feeling generally. You will also be asked to complete questionnaires about your quality of life.
The total duration of your participation will depend on how you respond to the treatment and for how long your doctor believes it is beneficial for you to continue. You will have regular follow-up appointments after treatment stops.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is acute myeloid leukaemia (AML)?
AML is a type of cancer that starts in the bone marrow, the soft, spongy tissue inside bones where blood cells are made. It causes the body to produce abnormal white blood cells.
What does 'treatment-naive' mean?
This means you have not had any previous specific treatment for your acute myeloid leukaemia before joining this study.
What are Venclyxto and Vidaza?
These are two medicines that are already approved and used for certain blood cancers. This study explores using them together for AML in a specific group of patients.
What does 'remission' mean in this study?
In this study, remission means that tests show the leukaemia cells have largely or completely disappeared from your body, or that they are present but your blood counts are recovering.
Will I have to pay to be part of this study?
No, you will not have to pay for the study medicines or any study-related tests or appointments.
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.