Relation Between Venetoclax Plasma Concentration and Remission in Adults with Acute Myeloid Leukemia (PREDICLAX)
This research study, called PREDICLAX, is for adults aged 60 to 90 who have been newly diagnosed with Acute Myeloid Leukemia (AML). These patients are taking a combination of venetoclax and azacitidine because standard chemotherapy isn't an option for them. The main goal is to understand if there's a link between how much venetoclax is in a patient's blood and whether their cancer goes into remission after the first cycle of treatment. Many patients don't go into remission, so finding this link could help doctors give more effective treatment in the future. Participants will have blood samples taken to measure the drug levels, but this study won't change their usual care.
At a glance
What is this study about?
Imagine you have a type of blood cancer called Acute Myeloid Leukemia (AML). For some people, standard chemotherapy isn't the best option, perhaps because of their age or other health conditions. In these cases, doctors might use a newer combination of medicines, venetoclax and azacitidine. While these treatments have helped many, doctors notice that more than half of patients don't go into remission, even after the first month of treatment.
This study, called PREDICLAX, wants to understand why some people respond well to venetoclax and others don't. Researchers believe that the amount of venetoclax in a patient's blood might play a role. They'll be comparing the levels of venetoclax in patients whose cancer goes into remission with those whose cancer doesn't. This isn't about changing your treatment; it's about learning from your experience.
The information gathered from this study is really important. If doctors can understand the right levels of venetoclax that lead to remission, they might be able to tailor treatments better in the future. This could mean more people with AML achieve remission and have better outcomes, ultimately helping doctors make more informed decisions about patient care.
Key takeaways
- This study is for adults (60-90) with newly diagnosed AML.
- It aims to link venetoclax blood levels to treatment success.
- Your AML treatment will not change if you participate.
- Participation involves giving extra blood samples during your regular visits.
- The study helps doctors understand how to improve future AML treatments.
Who may be eligible?
To join this study, you need to be an adult aged between 60 and 90, and have been recently diagnosed with Acute Myeloid Leukemia (AML) for the first time. You must be unable to have standard chemotherapy, either because you are 75 or older, or if you are between 60 and 74 and have certain other health conditions like heart problems, lung problems, or kidney issues.
You must also be suitable for treatment with the combination of venetoclax and azacitidine, which is your current standard care. You'll also need to agree to take part by signing a consent form.
You would not be able to join if your white blood cell count is very high, if you've had previous cancer treatment for AML or other cancers recently, or if your AML has spread to your brain or spinal cord, or if you have a specific type of AML called promyelocytic leukaemia (AML-M3). Also, if you have other serious health issues that are not well controlled, like a serious infection, severe heart problems, or certain mental health conditions, you wouldn't be able to participate.
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 between 60 and 90 years old.
- I have been recently diagnosed with Acute Myeloid Leukemia (AML) for the first time.
- My doctors have decided that standard chemotherapy is not the best option for me.
- I am currently receiving (or about to receive) venetoclax and azacitidine for my AML.
- I am willing to provide extra blood samples during my normal clinic visits.
- I don't have very high white blood cells or specific severe health issues mentioned by the doctors.
What does participation involve?
If you decide to take part in this study, your usual care with venetoclax and azacitidine will continue exactly as your doctors planned – the study won't change your treatment. The main thing you'll do for the study is provide some extra blood samples. These samples will be taken during your regular treatment visits. The purpose of these blood tests is to measure the amount of venetoclax in your blood. This is a simple procedure, similar to any other blood test you might have. You won't need to make extra visits specifically for the study. The total duration of your participation will depend on your treatment plan for AML, as the study observations will happen alongside your first treatment cycle.
Potential risks and benefits
Locations (1)
- CHU de CaenVerified postcodeCaen, France· Recruiting
Common questions
What is AML?
AML stands for Acute Myeloid Leukemia, which is a type of cancer that starts in the blood-forming cells of the bone marrow.
What is venetoclax?
Venetoclax is a medication used in combination with other drugs to treat certain blood cancers, including AML.
Will my treatment change if I join this study?
No, your treatment plan will not change. You will continue to receive the venetoclax and azacitidine combination as prescribed by your doctor as standard care.
What do I have to do if I join?
You will have extra blood samples taken during your routine clinic visits to measure the levels of venetoclax in your blood.
Is this study safe?
Yes, this study has very low risks. It mainly involves blood tests, which are a common and safe procedure.
How to find out more
Sylvain Chantepie, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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