Phase 1/2 evaluating the addition of venetoclax to standard 3+7 and midostaurin induction treatment in patients with FLT3-mutated Acute Myeloid Leukemia eligible to intensive chemotherapy - MIDOVEN
This research study, called MIDOVEN, is investigating a new treatment approach for adults with a specific type of blood cancer called FLT3-mutated Acute Myeloid Leukaemia (AML). This kind of AML has a particular change in the cancer cells (a 'FLT3 mutation'). The study is testing whether adding a new drug, venetoclax, to the standard initial chemotherapy and another medicine called midostaurin is safe and effective. Researchers want to see if this combination helps more patients achieve remission, meaning the cancer is no longer detectable, and keeps it away for longer. It's an early-stage study (Phase 1/2) that first checks for safety and then looks at how well the new treatment works.
At a glance
What is this study about?
This study, known as MIDOVEN, is for people diagnosed with a certain kind of blood cancer called Acute Myeloid Leukaemia (AML) that has a specific change, or 'mutation,' in a gene called FLT3. This particular type of AML can sometimes be harder to treat, so doctors are always looking for better ways to help patients.
The main idea behind this study is to see if adding a new medicine called venetoclax to the standard initial treatment can improve outcomes for patients. The standard treatment in this case involves chemotherapy (which is often called '3+7' because of how it’s given) and another targeted drug called midostaurin. Researchers believe that venetoclax, when combined with these other medicines, might make the treatment more effective at getting rid of the cancer cells. This study is an early phase trial (Phase 1/2), which means the first part focuses on finding the right and safest dose of venetoclax to use in combination, and the second part then looks at how well this combined treatment works for patients.
The researchers will be carefully checking for any side effects from the new combination of drugs during the initial treatment. They will also look at whether more patients achieve 'remission,' which means the cancer cells are no longer found in the body. They are particularly interested in a deep remission where there's no trace of the disease, often referred to as 'MRD negative.' The goal is to find a treatment that is both safe and more successful at controlling this specific type of AML.
Key takeaways
- This study is for adults with a specific type of blood cancer (FLT3-mutated AML).
- It combines standard treatments with a new drug, venetoclax.
- The main goals are to check the new treatment's safety and how well it clears the cancer.
- It's an early-stage study to gather important information.
- Participation involves close monitoring and regular check-ups.
Who may be eligible?
To be able to take part in this study, you must be an adult, as the study is open to anyone aged 18 and older, male or female. There's no upper age limit mentioned, so older adults could also be considered.
The study is specifically for people who have been diagnosed with FLT3-mutated Acute Myeloid Leukaemia. This means your cancer cells must have a particular genetic change that doctors look for. You'll also need to be considered well enough by your doctor to receive intensive chemotherapy, which is a strong form of treatment.
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?
- Do you have FLT3-mutated Acute Myeloid Leukaemia?
- Has your doctor said you are well enough for intensive chemotherapy?
- Are you willing to participate in a study comparing new treatments?
What does participation involve?
If you decide to take part in this study, you would receive the standard initial chemotherapy treatment along with midostaurin, and also the new medicine, venetoclax. The study will likely involve frequent hospital visits, especially during the initial treatment phase, so doctors can carefully monitor your health and how you react to the medicines. They will perform blood tests and probably bone marrow samples to check for cancer cells and any side effects.
After the initial treatment, there might be further cycles of treatment (called consolidation) and then possibly a longer period of taking medication (maintenance) or a stem cell transplant, depending on your individual situation and your response to the initial treatment. Throughout these stages, you would have regular check-ups, which include blood tests and possibly other examinations, for a significant period to see how well the treatment works and to monitor for any side effects. The total length of your participation would depend on the study's plan and your individual treatment pathway.
Potential risks and benefits
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Common questions
What is FLT3-mutated Acute Myeloid Leukaemia?
It's a fast-growing blood cancer that affects your bone marrow. 'FLT3-mutated' means the cancer cells have a particular genetic change.
What is venetoclax?
Venetoclax is a medicine that helps destroy certain cancer cells by targeting a specific protein they rely on to survive.
What does 'intensive chemotherapy' mean?
This is a strong set of medicines used to kill cancer cells, often requiring a hospital stay and causing significant side effects.
What does 'remission' mean?
Remission means tests can no longer find signs of your cancer in your body. 'CR/CRi without MRD' means a very deep remission with no minimal residual disease.
Why is this called a Phase 1/2 study?
Phase 1 checks if the new treatment is safe and finds the right dose. Phase 2 then checks if it actually works to treat the cancer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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