“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at new drugs in combination with cytarabine for acute myeloid leukaemia (AML LI-1)
This trial is looking at new drugs in combination with cytarabine (Ara C) for acute myeloid leukaemia and high risk myelodysplastic syndrome (MDS).
Doctors often treat acute myeloid leukaemia (AML) and high risk MDS with intensive chemotherapy to try and get rid of it. But some people can’t or don’t want to have intensive chemotherapy. For these people doctors may use the chemotherapy drug cytarabine at a lower dose than in intensive chemotherapy. They know cytarabine works but are always looking for new treatments.
In this trial some people will have cytarabine and others will have cytarabine in combination with newer drugs. The researchers will compare the groups to find out which is best for treating people with AML and high risk MDS.
Who can enter
You may be able to enter this trial if you
- Have acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)
- Have satisfactory blood test results
- Are willing to use reliable contraception if your partner could become pregnant
- Are 60 years of age or older – some younger patients may be able to take part
You cannot enter this trial if you
- Have acute promyelocytic leukaemia (APL)
- Have already had chemotherapy to treat AML – apart form hydroxycarbamide or similar treatment to control your white blood cells
- Have chronic myeloid leukaemia (CML) that may be in the process of turning into AML (blast transformation)
- Are being treated for another cancer
- Have had a heart attack or heart pain (angina) that is not controlled by medication or a stroke in the last 6 months
- Are HIV positive
- Are pregnant or breastfeeding
If you have another serious heart problem or had a heart attack in the last year, you cannot have AC220, tosedostat or ganetespib but you may still be able to take part in this trial and have one of the other new drugs.
This is a phase 2/3 trial. It will recruit 1,000 people.
It is a randomised trial. You are put into a treatment group by a computer. Neither you nor your doctor can choose which group you are in. The groups are
- Cytarabine and AC220
- Cytarabine (which is the
- Cytarabine and vosaroxin
- Cytarabine and ganetespib
- Cytarabine and tosedostat
- Cytarabine and selinexor
- Cytarabine and lenalidomide
Please note: People are no longer been put into the vosaroxin, sapacitabine and, cytarabine and vosaroxin treatment groups.
Not all of these treatment groups will be available at every centre, all of the time. Your doctor will tell you which ones are available to you.
The treatments repeat every 4 to 6 weeks, depending on the treatment you are having and how your AML responds to treatment. Each 4 to 6 week period is called a cycle of treatment.
You have cytarabine as an injection under the skin. You have it twice a day for 10 days every 4 to 6 weeks. You may be able to have this at home. You can talk to your doctor about this.
AC220 is a tablet. You take it for the first 3 weeks of each cycle of treatment. You take this at home.
You have ganetespib as a drip into a vein. You have it on days 1, 8, 15, 22 and 29 of each cycle of treatment. It takes 1 hour to have.
Tosedostat is a capsule which you take every day for 6 months. You take it at home. After completing cytarabine, you can continue to take tosedostat as above.
Selinexor is a tablet which you take twice a week between each treatment of cytarabine. After completing cytarabine, you can continue taking selinexor once a week.
Lenalidomide is a capsule you take once a day for 3 weeks. You take this at home.
You have at least 4 cycles of treatment. You may continue having treatment as long as it is helping you.
You fill in a questionnaire before starting treatment and at 3, 6 and 12 months. It will ask about how you have been and any side effects you have. This is called a quality of life study.
The researchers will also ask your permission to store blood and bone marrow samples. They will take the blood samples when you have your routine samples taken. And the bone marrow samples from when you had your bone marrow test done. These samples will be used in future to find out more about AML. You don’t have to agree to these if you don’t want to. You can still take part in the main trial.
The researchers may also ask for additional blood samples if you are having one of the new drugs. This is to find out more about the how the drug is working.
You will see the doctor and have some tests before starting treatment. These may include
- Blood tests
- Heart trace (
When you have started your treatment you have blood tests and if taking AC220 a heart trace (ECG).
The most common side effects of the drugs used in this trial are
- Feeling or being sick
- Sore mouth
- Hair loss
- A drop in blood cells causing an increased risk of infection, bleeding or bruising
- Liver changes
- Heart changes
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.
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer