A trial looking at blinatumomab for children and teenagers with acute lymphoblastic leukaemia
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is for children and teenagers with a type of acute lymphoblastic leukaemia called pre cursor B cell ALL that has come back after initial treatment.
The trial is for children and teenagers up to the age of 18. We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.
More about this trial
Acute lymphoblastic leukaemia (ALL) is initially treated with chemotherapy. You have it in 2 stages. The first is to get rid of the leukaemia (induction stage). The second is to stop it coming back (consolidation stage).
If your ALL comes back you have more chemotherapy in the same way. You might also have a 
from a donor, if your doctor thinks you are suitable.
Blinatumomab is a type of targeted cancer drug (a biological therapy) called an immunotherapy. It works by helping the body’s immune system recognise and kill leukaemia cells.
Researchers think blinatumomab might help children and teenagers with ALL that has come back after their initial treatment. To find this out they want to compare blinatumomab with used for ALL that has come back.
The aims of the trial are to find:
- how well blinatumomab works for children and teenagers with ALL that has come back
- more about the side effects of blinatumomab
- how safe blinatumomab is
- how safe it is to give blinatumomab before a stem cell transplant
Who can enter
The following bullet points list 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.
You may be able to join this trial if all of the following apply.
- You have a type of acute lymphoblastic leukaemia called precursor B cell ALL
- Your leukaemia has come back after your initial treatment
- There are samples available to the researchers that confirm your leukaemia has come back – your doctor can let you know if these are available
- Your
bone marrow contains less than 25% leukaemia cells - You have satisfactory blood test results
- You are at least 28 days old and less than 18 years old
As well as the above, teenagers who are sexually active must be willing to use reliable contraception during the treatment phase of the trial and for 6 months to 1 year afterwards (depending on your treatment) if there is any chance they or their partner could become pregnant.
You cannot join this trial if any of these apply.
- Your leukaemia has the
Philadelphia chromosome - Your leukaemia has spread to your brain or spinal cord (central nervous system). You might be able to join if there were signs of ALL in your central nervous system when your ALL came back (relapsed) but you have had this successfully treated
- You have a condition that affects your central nervous system that is not well controlled, for example, you have epilepsy that is not stable
- You still have moderate to severe side effects from previous chemotherapy
- You have had an experimental drug or used a device as part of a clinical trial within the past 4 weeks
- You have a medical condition, such as seizures (fits), that affects your brain or spinal cord that isn’t controlled
- You have HIV
- You have any other medical or mental health condition that the trial team think could affect you taking part
- You are allergic to immune system proteins called immunoglobulins, any of the medications or their ingredients used in this trial
- You are pregnant or breastfeeding
Trial design
This is an international phase 3 trial. The researchers need a total of 202 children and teenagers worldwide to join. Of these, about 11 children and teenagers will be from the UK.
You have 2 courses of standard chemotherapy to get rid of the ALL. You then have either blinatumomab or standard chemotherapy.
This is a randomised trial. Everyone is put into 1 of 2 treatment groups by a computer:
- blinatumomab
- standard chemotherapy
Neither you or your doctor can choose which group you are in.
You have blinatumomab as a drip into a vein. A bag of fluid containing blinatumomab is attached to a . This gives a certain amount of blinatumomab continuously over 4 weeks. Your nurse or doctor will set the pump up.
During blinatumomab treatment you stay in hospital between 3 and 7 days when the treatment starts. This is to make sure you are all right and the pump is working. After this you can go home. You go back to the hospital when the bag of fluid needs changing. A member of your medical team will do this.
You have the standard chemotherapy treatment as a drip into a vein. You have 1 week of treatment. You may need to stay in hospital for 6 days during the treatment.
Everyone has treatment to stop ALL spreading to the brain and spinal cord. This is called CNS prophylaxis. You have this as an injection into your spine. This is the same as having a .
As part of your treatment you might have a donor stem cell transplant (an allogeneic transplant). You doctor will talk to you about this.
You have some extra blood samples taken when you have your routine blood tests. This is to:
- see how much blinatumomab is in your blood
- look for substances (biomarkers) that might show how well blinatumomab is working
- look for
antibodies to blinatumomab
Hospital visits
You see the doctor to have some tests before taking part. These tests include:
- a physical examination
- blood tests
- urine test
- lumbar puncture
- bone marrow test
- a test to see how your brain and nervous system are working (neurological test)
You see the doctor 2 weeks after starting treatment. This is to have:
- blood tests
- urine test
- bone marrow test - only for those having bilnatumomab
You see the doctor a month after starting treatment for:
- blood tests
- urine test
- bone marrow test and lumbar puncture. For those having a donor stem cell transplant (allogenic transplant) this is a week before your transplant
You see the doctor within 7 days before your transplant. This is to have:
- a physical examination
- a test to see how your brain and nervous system are working
You see the doctor after your treatment started or after your transplant at:
- 45 days
- 3 months
- 6 months
- 9 months
- 1 year
This is to have:
- a physical examination
- blood tests
- urine test
- bone marrow test
- a test to see how your brain and nervous system are working - only at the 3 month visit
After 1 year you are followed up every 3 months for 2 years to see how you are. You might go to the outpatients' clinic to see the doctor. Or the trial team will phone and, or email you.
Side effects
Blinatumomab is a new drug and there might be side effects we don’t know about yet. The most common side reported so far include:
- a drop in blood cells causing an increased risk of infection, breathlessness, bruising and bleeding
- tummy (abdominal) pain
- diarrhoea
- constipation
- tiredness
- chest pain
- bone and joint pain
- back pain
- pain in the arms, hands and legs
- cough
- skin rash
- difficulty sleeping including falling asleep and staying asleep
- weight gain
- general swelling
- increase in the level of sugar in your blood
- decrease in the level of magnesium and potassium in your blood
While having blinatumomab
Your body might release a large amount of a substance called cytokines. This is called cytokine release syndrome. You might have the following:
- high temperature (fever)
- chills
- headache
- low blood pressure
- increase in liver enzymes
- feeling or being sick
These are generally mild to moderate but can occasionally be serious or life threatening. You doctor might give you medication such as steroids to prevent or treat this.
Blinatumomab can also affect your nervous system. You might have problems such as:
- shaking
- feeling dizzy
- fits (seizures)
- feeling sleepy
- burning, prickling or tingling of the skin
- difficulty speaking or slurred speech
- difficulty understanding words
- difficulty walking
- memory loss
- confusion
- loss of balance
These can be serious or life threatening. Your doctor tests your nervous system before starting treatment and monitors you very closely during treatment. They might also give you steroids or other medication to treat this if it happens or consider stopping blinatumomab.
Your doctor will talk to you about the side effects of all the treatments used in this trial before you agree to take part.
We have information about the standard chemotherapy drugs used for ALL.
We have information about stem cell transplants.
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
Professor Ajay Vora
Supported by
Amgen
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
