Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study looking at treatment for older adults with acute lymphoblastic leukaemia (UKALL60+)
This is a study to find the best way to treat acute lymphoblastic leukaemia in people over the age of 60.
Cancer Research UK supports this study.
More about this trial
The aim of this study is to find a standard treatment for ALL in adults over the age of 60. Researchers can then use this in the future as a comparison when looking at any new treatments in clinical trials.
Who can enter
You may be able to enter this study if you
- Have been diagnosed with acute lymphoblastic leukaemia and have not had any treatment yet
- Are over 60 years old (or over 55 if you cannot take part in another trial called UKALL14 or HOVON 100)
Male patients must be willing to use reliable contraception during the trial and for a year afterwards if there is any chance their partner could become pregnant.
You cannot enter this study if you
- Have a type of acute lymphoblastic leukaemia called mature B cell
- Are pregnant or breastfeeding
- Are known to be HIV positive
This phase 2 study will recruit about 148 people. Everybody joining the trial takes steroid tablets for up to a week. During this time, your doctor will decide the best chemotherapy treatment for you to have. There are 4 different treatment plans you can have as part of this trial and each plan is made up of different phases. The possible phases are
- Induction – this aims to get rid of the leukaemia cells
- Intensification – this aims to stop leukaemia cells getting into the fluid around your brain and spinal cord
- Consolidation – this aims to stop the leukaemia coming back
- Maintenance treatment – this aims to stop leukaemia coming back in the long term
The details of each treatment plan are too complicated to go into detail about here. The outlines of the different plans are below. The study team will tell you more about the drugs you will have and how you have them.
People who have ALL with a change to a specific gene which doctors describe as being
If your ALL is not Philadelphia positive, you have 1 of the other 3 treatment plans. Two of the plans are very similar and are called intensive treatments.
In one of them you have induction treatment for 8 weeks, intensification for 4 weeks, consolidation for 12 weeks and then maintenance treatment for 2 years.
In the other one, you have induction treatment for 8 weeks, no intensification treatment, consolidation for just 8 weeks and then maintenance treatment for 2 years.
The 4th treatment plan is less intensive and may be suitable for you if your doctors don’t think you are well enough to have either of the treatments above. With this plan, you have induction treatment for 8 weeks, consolidation for 4 weeks and then 2 years of maintenance treatment.
Some people joining the study will not have any of the treatment plans above. They will have the treatment that people usually have for ALL at the hospital where they are being treated. By joining the study, they allow the researchers to collect information about the treatment they have and how they get on.
The study team will ask you to fill out 4 questionnaires before you start treatment, at different times during treatment and after you finish treatment. The questionnaires will ask about side effects and how you’ve been feeling. The questionnaires are called quality of life studies.
The study team will also ask if you would be willing to have a swab taken from the inside of your cheek (a buccal swab). This provides them with a sample of cells so they can look at your
You have a diary and the trial team will ask you to keep a record of when you take each drug. You return the diary to the trial team when you finish the trial.
You see the study doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Bone marrow test
You may also need to have a lumbar puncture.
You will be in hospital for some of your treatment. The trial team can tell you more about this.
You will have regular physical examinations and blood tests throughout your treatment. You will also have 3 more bone marrow tests.
After you finish treatment, you will see the trial team once a year for 5 years.
The most common side effects of the chemotherapy drugs in this trial include
- Hair loss
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Sore mouth
If you have Philadelphia positive ALL, your treatment will include a drug called imatinib. The side effects of imatinib include
- Feeling or being sick
- Swelling in your face or legs
- Muscle cramps
If you have intensive treatment one of the drugs that can be used is pegylated asparaginase. Side effects of this drug can include
- Blood clots (thrombosis)
- High temperature (fever)
- Changes to the way your liver, kidneys, pancreas and thyroid work
- Confusion, hallucinations, loss of consciousness and more rarely fits (seizures)
How to join a clinical trial
Professor Adele Fielding
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)