A SAFETY RUN-IN AND PHASE 2, OPEN-LABEL, MULTICENTRE, STUDY INVESTIGATING SAFETY, TOLERABILITY AND EFFECTIVENESS OF VENETOCLAX ADD IN COMBINATION AT FLUDARABINE, CYRATABINE AND IDARUBICINE IN INDUCTION THERAPY OF NEW ONSET NON-M3 ACUTE MYELOID LEUKEMIA. V-FIRST - AML1718
Acute myeloid leukaemia (AML) is an aggressive cancer of the white blood cells that requires prompt treatment. The first round of treatment, known as induction therapy, aims to clear cancer cells and bring about a remission. Standard therapy usually involves intensive chemotherapy. This clinical study, called V-FIRST, is testing a new approach for adults who have just been diagnosed with AML (excluding a specific subtype called M3). It combines standard chemotherapy drugs (fludarabine, cytarabine, and idarubicin) with a newer targeted tablet called venetoclax. Venetoclax works by blocking a specific protein that keeps cancer cells alive. Doctors want to find out if this combination is safe, what side effects it causes, and whether it helps more people achieve complete remission compared to standard care alone. The study also tracks participants' quality of life throughout treatment.
At a glance
What is this study about?
Acute myeloid leukaemia (AML) is a fast-growing cancer that affects the blood and bone marrow. When someone is first diagnosed, doctors usually start treatment straight away with intensive chemotherapy, called 'induction therapy'. The main goal of induction is to clear out the leukaemia cells so healthy blood cells can grow back—a state known as remission.
While standard chemotherapy can be very effective, doctors are constantly looking for ways to improve response rates and help remissions last longer. This trial studies the effect of adding an anti-cancer drug called venetoclax to a well-known chemotherapy regimen known as FLAI (which includes fludarabine, cytarabine, and idarubicin). Venetoclax comes as a tablet and targets a protein that cancer cells use to hide from normal cell death.
By attacking leukaemia cells from two different angles—using chemotherapy to damage their DNA and venetoclax to trigger their self-destruction—researchers hope the combination will be more powerful than chemotherapy on its own. The study is split into stages to first confirm the safest dose and monitor side effects, before seeing how many patients achieve complete remission.
Taking part in this research helps doctors understand whether this combined treatment is safe and effective enough to become a standard option for people newly diagnosed with AML in the future.
Key takeaways
- The trial tests adding venetoclax tablets to standard intensive chemotherapy (FLAI) for newly diagnosed AML.
- It aims to see if the combination safely improves remission rates.
- Open to adults aged 18 and over who have not yet started treatment for non-M3 AML.
- Requires an inpatient hospital stay for intensive treatment and close safety monitoring.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is designed for adults aged 18 and older who have recently been diagnosed with acute myeloid leukaemia (AML) and are preparing to start their first round of intensive treatment.
It is specifically for patients with non-M3 AML. M3, also known as acute promyelocytic leukaemia, is a different subtype of AML that is treated with completely different medicines, so people with that specific type cannot take part.
Because the treatments used in this trial are intensive, participants generally need to be well enough to tolerate strong chemotherapy and have reasonably healthy heart, kidney, and liver function. Your hospital medical team will carry out detailed checks to confirm whether this study is safe and suitable for you.
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 aged 18 or older.
- I have been newly diagnosed with acute myeloid leukaemia (AML).
- My leukaemia is not the 'M3' (acute promyelocytic) subtype.
- I have not yet started intensive induction chemotherapy.
- I am well enough to undergo intensive inpatient hospital treatment.
What does participation involve?
Taking part in this study involves receiving intensive hospital-based cancer treatment. The chemotherapy drugs (fludarabine, cytarabine, and idarubicin) are given through a drip into a vein, while venetoclax is taken daily as tablets by mouth. Treatment is given in cycles, with most patients receiving one or two cycles of induction therapy.
Because induction chemotherapy temporarily lowers your body's ability to fight infection, you will likely need to stay in the hospital for several weeks during each cycle. While in hospital, your care team will closely monitor you with regular blood tests, physical examinations, heart checks (ECGs), and checks for any side effects. You will also have bone marrow tests to see how well the leukaemia is responding. You will be asked questions about your overall wellbeing and quality of life, and doctors will follow your health for up to a year, including after any future stem cell transplant.
Potential risks and benefits
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Common questions
What is venetoclax?
Venetoclax is a targeted medicine taken as a tablet. It works by blocking a protein called BCL-2, which helps leukaemia cells survive, encouraging the cancer cells to die off naturally.
What does 'non-M3 AML' mean?
AML has several different subtypes. 'M3' (acute promyelocytic leukaemia) responds very well to specific targeted vitamins and medicines rather than standard chemo. This study is only for patients with other, non-M3 types of AML.
Will I have to stay in hospital?
Yes. Intensive induction chemotherapy causes blood cell counts to drop significantly, meaning you will need close monitoring and support in hospital for several weeks to keep you safe from infections and other complications.
What is tumour lysis syndrome?
When cancer treatments work quickly, many leukaemia cells break open at once, releasing their contents into the bloodstream. Doctors watch for this carefully with blood tests and give plenty of fluids and medicines to protect your kidneys.
Can I leave the study if I change my mind?
Yes, you can leave the study at any point. You do not have to give a reason, and your medical team will continue to provide you with the best available standard NHS treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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