The trial team found that blinatumomab worked for some people with ALL whose TKI treatment hadn’t worked. And the side effects were manageable.
The trial team recruited people between 2014 and 2015. The researchers published the results in 2017.
Treatment
Everyone had blinatumomab. They had treatment in cycles. Each 4 week period was 1
cycle of treatment. Everyone had at least 2 cycles of treatment.
Results
The trial team looked at how well treatment worked. To do this they looked at the results after 2 cycles of treatment. They looked at:
- whose ALL had either gone away completely or had gone away but their blood test results hadn’t fully recovered
They found that this happened in 16 people out of the 45 . Of those:
- 14 had no signs of leukaemia in their blood tests - this is called minimal residual disease
- 2 had some signs of leukaemia in their blood tests
7 out of the 16 went on to have a stem cell transplant with somebody else’s cells (
allogenic transplant 
).
The researchers also looked at how long people lived. This is called overall survival. On average this was about 7 months.
Side effects
The most common side effects of blinatumomab were:
- high temperatures (fever)
- an increased risk of infection (neutropenia) with a fever
- headaches
The more serious side effects were an increased risk of:
- infection (neutropenia) with a fever
- bleeding
- tiredness and breathlessness (anaemia)
The researchers also found that:
- 3 people developed mild problems from a side effect called cytokine release syndrome – this causes fever, sickness, headache, rash, rapid heartbeat, low blood pressure, and trouble breathing
- 3 people had problems with their central nervous system
including 1 person who had difficulty speaking. Their treatment was stopped for a short time and this side effect got better.
Conclusion
The trial team concluded that blinatumomab worked for some people with acute lymphoblastic leukaemia that has the
Philadelphia chromosome 
. And the side effects were manageable.
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (
peer reviewed 
) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.