
"I am glad that taking part in a trial might help others on their own cancer journey.”
This study is looking at blinatumomab for people with acute myeloid leukaemia (AML). It is for people with AML that came back after induction chemotherapy and has a certain chromosome change.
Doctors can treat AML with chemotherapy. There are 2 phases to the chemotherapy. The first phase is to get rid of the leukaemia cells. This is induction chemotherapy. The second phase is to stop AML coming back. This is consolidation chemotherapy.
Unfortunately sometimes the induction and consolidation chemotherapy doesn’t get rid of all of the leukaemia cells.
Inside every cell are that contain the
of the cell. Some leukaemia cells have changes to the chromosomes. One change is when chromosome 8 breaks apart and chromosome 21 breaks apart. And then these 2 chromosomes join up. Doctors call this translocation 8;21 or t(8;21).
People who have this translocation have an abnormal gene within their leukaemia cells. Doctors can track the gene and detect the leukaemia coming back at a very early stage. If this happens they would usually need more intensive chemotherapy. And they might have . This treatment has significant side effects.
Blinatumomab is a called a
. It works by helping the
recognise the leukaemia cells and attack them.
Researchers think that blinatumomab might help people whose leukaemia:
Everyone in this study has blinatumomab. The aim of this study is to find out how well blinatumomab works for people in this situation.
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You:
This is a phase 2 study. The team need 17 people to join. Everyone has blinatumomab.
You have blinatumomab as a drip into a vein through a .
You have dexamethasone through the central line before starting blinatumomab. This is to help reduce the side effects of blinatumomab.
You have the treatment in cycles. Each is 6 weeks. You have blinatumomab as a continuous infusion over 4 weeks. Then you don’t have blinatumomab for the next 2 weeks.
For the 1st cycle of treatment, you are in hospital for 3 days after starting blinatumomab. For the rest of the treatment cycles you are in hospital for 2 days at the start of treatment.
This is so the nurses can monitor you for any side effects that might happen at the start of each cycle of treatment.
After leaving hospital you have a Continuous Ambulatory Delivery Device (CADD) pump attached to your central line. This delivers the blinatumomab continuously for the remainder of the treatment cycle. The nurses will tell you how to look after the CADD pump. Do not stop the pump or disconnect it from the central line. Contact your health care team or advice line if the pump isn’t working properly or you are concerned about it.
During treatment, you see the doctor often. This is to see how well the blinatumomab is working. You have between 1 and 4 cycles of treatment. How many cycles you have depends on:
When you stop blinatumomab your doctor will talk to you about what treatment you might have next.
You see the doctor to have tests before taking part. These tests include:
You see the doctor once a week for the 4 weeks you are having blinatumomab and at the end of each cycle of treatment. This is to see how you are and for blood tests.
You don’t see the doctor during the 2 weeks you aren’t having blinatumomab.
You will usually have a bone marrow test after each cycle of treatment. And you may have this test again at some of your follow up appointments. You would have these as part of your routine care anyway. There are no extra bone marrow tests as part of this trial.
You see the doctor 3 months after your last cycle of treatment. This is to see how you are and for:
You then see the doctor every 3 months for a year and then every 6 months for the second year.
The study 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.
We have more information about blinatumomab and its side effects.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Richard Dillon
Amgen
Guy's and St Thomas' NHS Foundation Trust
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”