FILO-AML-01-MIVONU A single arm phase II study investigating the efficacy and safety of the addition of ivosidenib to oral azacitidine (Onureg®) in patients over 55 with Acute Myeloid Leukemia (AML) and IDH1 mutation, in complete remission after intensive chemotherapy. A study of the French AML Intergroup.
This study, called FILO-AML-01-MIVONU, is looking at a new way to treat older patients (over 55) who have a specific type of blood cancer called Acute Myeloid Leukaemia (AML) and a particular gene change (IDH1 mutation). These patients have already had strong initial treatment and are currently in remission, meaning their cancer is not detectable. The study wants to see if adding a drug called ivosidenib (also known as Tibsovo) to another drug called oral azacitidine (Onureg) can help prevent the cancer from coming back. Researchers will be checking how many people remain cancer-free for at least 24 months. It’s an early-stage study, checking both how well the treatment works and if it's safe.
At a glance
What is this study about?
This study, known as FILO-AML-01-MIVONU, is for people over 55 who have a type of blood cancer called Acute Myeloid Leukaemia (AML). Specifically, it's for those who have a certain gene change in their cancer, called an IDH1 mutation. These patients have already been through intensive chemotherapy, which is a strong initial treatment, and are now in 'complete remission'. This means their cancer signs have disappeared or are no longer detectable.
The main goal of this study is to see if adding a new drug, ivosidenib (which you might hear called Tibsovo), to an existing oral medication, azacitidine (Onureg), can help keep the cancer from coming back. The researchers want to find out how many people remain cancer-free 24 months (two years) after starting this combination treatment. They are also looking to see how safe this combination is and if patients experience many side effects.
This is a 'Phase II' study, which means it's an earlier stage of research. It's designed to explore if the treatment works and to get a better understanding of its safety before potentially moving on to larger studies. The results from studies like this are crucial in finding better ways to manage AML and improve patients' lives.
Key takeaways
- This study is for people with AML and an IDH1 gene change.
- Participants must be in remission after strong initial chemotherapy.
- It tests if adding ivosidenib to oral azacitidine helps prevent cancer return.
- The main goal is to see how many people stay cancer-free for 24 months.
- It's an early-stage study to understand effectiveness and safety of a new combination.
Who may be eligible?
This study is for adults diagnosed with Acute Myeloid Leukaemia (AML). You must have a specific gene change in your cancer cells, called an IDH1 mutation. Importantly, you must have already completed intensive chemotherapy treatment and currently be in 'complete remission', meaning your cancer is not detectable.
While the study description mentions patients over 55, it's worth noting the raw eligibility criteria also state ages from 18 upwards. This means if you are an adult patient (18 years or older) with AML, an IDH1 mutation, and are in remission after intensive chemotherapy, you might be considered.
The study is open to both men and women who meet these criteria. There will be other health checks and requirements that your doctor will discuss with you to make sure the study treatment is suitable for your individual health situation.
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 an adult with Acute Myeloid Leukaemia (AML)?
- Does your AML have an IDH1 gene mutation?
- Have you completed intensive chemotherapy for your AML?
- Are you currently in complete remission (no detectable cancer signs)?
- Are you able to take oral medication (tablets)?
- Are you at least 18 years old?
What does participation involve?
Taking part in this study would involve starting a combination of two oral medications: ivosidenib (Tibsovo) and oral azacitidine (Onureg). These are tablets you would take.
You would have regular appointments with the study team. These visits would involve check-ups, blood tests, and possibly other tests to monitor your health, how well the treatment is working, and to check for any side effects. The study team would closely supervise your treatment.
You would continue to be monitored for a substantial period after starting treatment, with the main goal being to see how you are doing after 24 months. The total duration of your participation, including follow-up, would be fully explained by the study team.
Potential risks and benefits
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Common questions
What is AML?
AML stands for Acute Myeloid Leukaemia, which is a fast-growing cancer of the blood and bone marrow.
What does 'IDH1 mutation' mean?
An IDH1 mutation is a specific change found in the genes of some AML cancer cells. This study is for patients whose cancer has this particular change.
What does 'complete remission' mean?
Complete remission means that after treatment, tests no longer show any signs of the cancer in your body.
What are ivosidenib and oral azacitidine?
These are two different medications. Ivosidenib (Tibsovo) is a newer drug that targets cells with the IDH1 mutation, and oral azacitidine (Onureg) is an existing drug used to treat AML.
Why 24 months?
The study's main aim is to see how many people remain cancer-free for at least 24 months (two years), as this is an important timeframe for assessing treatment effectiveness in AML.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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