"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at blinatumomab for people with acute lymphoblastic leukaemia (ALL)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called blinatumomab for people who have pre B cell acute lymphoblastic leukaemia (ALL).
Doctors usually treat ALL with different chemotherapy drugs.
When you finish chemotherapy you have tests to see how it has worked. Although these may show that your ALL has gone away (
The aim of this study is to find out if blinatumomab can help stop or slow down the growth of ALL.
Who can enter
You may be able to enter this trial if you
- Have pre B cell acute lymphoblastic leukaemia that has gone away but some cells remain in your bone marrow (MRD)
- Have satisfactory blood test results
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are willing to use reliable contraception during the study and for 3 months afterwards if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer
- Have any medical illness that is a cause for concern
- Have or have had
- Have had a stem cell transplant using donor cells in the past
- Have had a stem cell transplant using your own cells in the last 6 weeks
- Have had treatment with monoclonal antibodies eg rituximab and alemtuzumab in the last 4 weeks
- Have had any treatment in a trial in the last 4 weeks
- Know you are allergic to blinatumomab or immunoglobulin
- Have had chemotherapy in the last 2 weeks
- Have had radiotherapy in the last 4 weeks
- Have HIV, hepatitis B or hepatitis C
- Are pregnant or breastfeeding
The trial will recruit 100 people from around the world.
Everybody on the trial will have blinatumomab. You have it through a central line (a central venous catheter) into a vein in your chest for 4 weeks out of every 6. Each 6 week period is called a cycle of treatment.
You have blinatumomab through a pump. The pump gives you a continuous dose of blinatumomab over 4 weeks. You go home with the pump attached to you and can walk around as normal. The pump fits into a small bag that you can attach to a belt. You have up to 4 cycles of treatment.
You fill out a questionnaire before you start treatment and once during every cycle. Then you fill one out again a month after your treatment has finished and then every 3 months for a year. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.
You see the trial doctors and have some tests before you start treatment. The tests include
You have these tests repeated frequently while you are on the study.
Each time you have treatment you stay in hospital. This will be for 3 days for your first treatment and then for 2 days each time you have treatment after that. The pump will need changing twice a week. You can go to the hospital or a nurse may come to your home to change it.
You see the trial doctors a month after you finish treatment and then every 3 months for 2 years. The research team will then contact you every 6 months to see how you are.
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.
Professor Adele Fielding
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer