A study of blinatumomab for acute myeloid leukaemia (BlinAML)

Cancer type:

Acute leukaemia

Blood cancers

Leukaemia

Status:

Open

Phase:

Phase 2

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.

More about this trial

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 chromosomes Open a glossary item that contain the genes 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 stem cell transplant Open a glossary item . This treatment has significant side effects.

Blinatumomab is a targeted drug Open a glossary item called a monoclonal antibody . It works by helping the immune system recognise the leukaemia cells and attack them.

Researchers think that blinatumomab might help people whose leukaemia:

has come back after induction therapy and
has the t(8;21) chromosome change and
has been detected at a very early stage

Everyone in this study has blinatumomab. The aim of this study is to find out how well blinatumomab works for people in this situation.

Who can enter

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:

have acute myeloid leukaemia (AML) that has the 8;21 translocation of the chromosomes
have a bone marrow test that shows there are less than 5% immature cells (blasts cells) in the bone marrow (a haematological response ). And it also shows that the 8;21 translocation has come back, or it is still present.
have AML that has come back after induction chemotherapy. And this included at least 2 courses of treatment with an anthracycline chemotherapy or 1 course of treatment with an anthracycline and 1 course of treatment with high dose cytarabine (HDAC).
have a bone marrow test result or blood test result from when you were diagnosed that shows your AML has the CD19 protein
have satisfactory blood test results
are up and about for at least half the day but might not be able to work (performance status 0, 1 or 2)
are willing to use contraception during treatment and for a time after. This is if there is any chance you or your partner could become pregnant.
are at least 18 years old

Who can’t take part

Cancer related
You cannot join this study if any of these apply. You:

have 5% or more blast cells in the bone marrow
have blast cells in the blood
have AML in the body as a solid mass outside of the bone marrow (extramedullary AML)
have AML in the fluid surrounding the brain and spine
have had another cancer within the past 5 years. This is apart from non melanoma skin cancer and in situ carcinoma of the cervix.
have had a stem cell transplant from a donor (allogeneic transplant) within 3 months of starting study treatment
have had chemotherapy that reaches your whole body (systemic treatment) within 2 weeks of starting study treatment
have had radiotherapy within 4 weeks of starting study treatment
have had an experimental drug or used a device as part of a clinical trial within 4 weeks of stating study treatment
are taking part in another clinical trial or study
have had blinatumomab before

Medical conditions
You cannot join this study if any of these apply. You:

weigh less than 45kg (7st)
have or had certain autoimmune diseases . Talk to your doctor they will know which ones these are.
have or had problems with your brain or spinal cord. This includes seizures (fits), problems speaking, dementia, injuries, problems with walking and coordination, muscle weakness, Parkinson’s disease or mental health problems. You doctor will know which problems can affect you taking part.
have HIV, hepatitis B or an active infection. You could join if you have hepatitis C as long as you have had it for a long time and it is well controlled.
have any other medical condition or social situation that could affect you taking part

Other
You cannot join this study if any of these apply. You:

are allergic or sensitive to the treatments or any of their ingredients
are pregnant or breastfeeding

Trial design

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 central line Open a glossary item .

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 cycle of treatment Open a glossary item 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.

Diagram 1

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:

how well treatment is working
your side effects

When you stop blinatumomab your doctor will talk to you about what treatment you might have next.

Hospital visits

You see the doctor to have tests before taking part. These tests include:

a physical examination
blood tests
urine test
test to check how well your brain and nervous system are working (neurological examination), this includes a writing test
heart trace (ECG )
bone marrow test

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:

a physical examination
blood tests
urine test
heart trace

You then see the doctor every 3 months for a year and then every 6 months for the second year.

Side effects

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.