A trial of venetoclax with low dose cytarabine for acute myeloid leukaemia (VICTOR)
Cancer type:
Status:
Phase:
This trial is comparing venetoclax and low dose cytarabine with intensive chemotherapy. It is for people with acute myeloid leukaemia aged 55 years and older. And who have a certain 
change () called NPM1.
Cancer Research UK supports this trial.
More about this trial
NPM1 is a gene change that happens by accident. It happens when the cells divide and grow. This gene change isn’t . You didn’t get it from your parents. And you can’t pass it on to your children.
The NPM1 gene change is the most common gene change for people with acute myeloid leukaemia (AML). And treatment usually works well for people who have it.
Chemotherapy is the main treatment for AML. The 2 chemotherapy drugs used most are:
As part of the intensive chemotherapy you also have gemtuzumab ozogamicin (Mylotarg). Gemtuzumab ozogamicin is a with a chemotherapy drug attached. The antibody attaches to the leukaemia cells and the chemotherapy drug kills it.
Venetoclax is a called a cancer growth blocker. It works by blocking proteins on cancer cells that help them grow and divide. It also makes cancer cells more sensitive to chemotherapy. Which means doctors might be able to give smaller doses of chemotherapy with venetoclax. And this will cause less side effects.
Venetoclax is already used for another type of leukaemia called chronic lymphocytic leukaemia (CLL).
Researchers think that having venetoclax with cytarabine might work well for people with AML. In this trial they are comparing venetoclax and cytarabine with standard intensive chemotherapy (daunorubicin, cytarabine and Mylotarg).
The aims of the trial are to find out:
- how well the combination of venetoclax and cytarabine works when compared with standard intensive chemotherapy
- what the side effects are of venetoclax and cytarabine
- how this combination affects
quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
- have AML that has the antigen CD33 on the cells. Your doctor can tell you about this.
- have the NPM1 gene change (mutation). Your doctor can tell you whether you have this gene change or not.
- are fit enough to have intensive chemotherapy that includes an
anthracycline chemotherapy drug such as daunorubicin. Your doctor will know if you are fit enough. - can look after yourself but might not be able to work (performance status 0, 1 or 2)
- can swallow tablets whole
- are willing to use contraception during the trial and for a time after if you or your partner could become pregnant
- are at least 55 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have had chemotherapy for AML or any other blood cancer. This is apart from hydroxycarbamide to control your
blood cell count . - have another cancer that needs treatment
- are newly diagnosed with HIV or it is not controlled by medication. You might be able to join if your last 2 viral load tests were negative and your treatment does not include certain types of HIV drugs. Your doctor will know which drugs these are.
- have hepatitis B or hepatitis C. You might be able to join if your last 2 viral load tests were negative and your treatment does not include certain types of drugs. Your doctor will know which drugs these are.
- are sensitive to the drugs, or any of their ingredients, used in the trial
- are pregnant or breastfeeding
Trial design
This is an international phase 2 trial. The trial team need 156 people worldwide with about 140 people in the UK.
This is a randomised trial. There are 2 treatment groups. Neither you nor your doctor can choose which group you are in. The 2 groups are:
- standard intensive chemotherapy
- venetoclax and low dose cytarabine
Standard intensive chemotherapy
This includes 3 different chemotherapy drugs:
- daunorubicin
- cytarabine
- gemtuzumab ozogamicin (Mylotarg)
You have 4 . You go into hospital to have treatment and stay in until your blood test results are satisfactory. You have all the chemotherapy drugs as a drip into a vein.
Venetoclax and low dose cytarabine
You go into hospital to start treatment with venetoclax. For the first few days your doctor will vary the dose. After this you have venetoclax at home.
Venetoclax is a capsule. You take it once a day every day. You take it with a glass of water and within 30 minutes after breakfast or your first meal of the day.
You have cytarabine as an injection under the skin. You have it once a day for 10 days every 4 weeks. You go to the outpatient’s unit to have the injection.
Depending on your hospital you might be able to give the injection to yourself at home. Ask your health team about this. They will teach you how to do it if this is so.
You can have venetoclax for up to 2 years and cytarabine for up to 1 year as long as it is helping and the side effects aren’t too bad.
There are certain foods and medicines you must not have while taking venetoclax. Your doctor will talk to you about this.
Quality of life
You fill in questionnaires before starting treatment and during treatment and then after treatment at:
- 3 months
- 6 months
- 1 year
- 18 months
- 2 years
The questions ask about:
- your general health
- any side effects or symptoms
- what daily activities you can do
These are quality of life questionnaires.
Research samples
You have regular bone marrow tests as part of your routine care.
The trial team will ask for some of the sample if there is any left over. They will store these to do research on later to find out more about AML and its treatment.
You don’t have to agree to this. You can still take part in the trial.
Hospital visits
You see the doctor to have tests before taking part. These tests include:
- a
physical examination - blood tests
- bone marrow test
You see the doctor regularly during treatment to see how you are and for blood tests.
You have a bone marrow test every 4 weeks for a year and then every 3 months for another year.
You see the doctor within a month after finishing treatment for a physical examination and blood tests. They will then tell you how often they want to see you.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of venetoclax include:
A rare side effect of venetoclax is tumour lysis syndrome (TLS). This is caused by the fast breakdown of cancer cells releasing substances into the bloodstream.
TLS can cause a change to how your kidneys and heart work and can cause fits (seizures). TLS has been reported in another type of leukaemia (CLL) but not in AML. People who have a very high numbers of white blood cells might be at a higher risk of TLS. Your doctor takes regular blood tests to check on this.
The most common side effects of gemtuzumab ozogamicin (Mylotarg) include:
- a change to how your liver works
- tumour lysis syndrome
- a high level of sugar in the blood
- an increase in the time it takes for blood to clot
A less common side effect is blocking of the small vessels in the liver. Symptoms include:
- weight gain
- tummy (abdominal) pain
- swelling of the liver
- yellowing of the skin
You need to contact your doctor or the advice straight away if you have any of these symptoms.
We have more information about venetoclax and information about:
Your doctor or a member of the trial team will talk to you about the side effects of the treatments before you agree to take part.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Richard Dillon
Supported by
Cancer Research UK
University of Birmingham
Other information
This is Cancer Research UK trial number CRUK/19/013.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
