A trial looking at blinatumomab for acute lymphoblastic leukaemia (ALL)

Cancer type:

Acute leukaemia

Acute lymphoblastic leukaemia (ALL)

All cancer types

Blood cancers

Leukaemia

Status:

Results

Phase:

Phase 2

This trial used blinatumomab to reduce the small number of leukaemia cells left in the blood after treatment for B cell acute lymphoblastic leukaemia.

This trial was open for people to join between 2010 and 2013. The researchers published the results in 2018.

More about this trial

Doctors usually treat acute lymphoblastic leukaemia (ALL) with different chemotherapy drugs.

When you finish chemotherapy, you have tests to see how it has worked. But sometimes there are a small number of leukaemia cells still in the blood. This is minimal residual disease (MRD). The leukaemia will come back (recur) if these cells start to grow again. Doctors hoped that blinatumomab would prevent or delay this happening.

Blinatumomab is a type of targeted drug called a monoclonal antibody. Monoclonal antibodies seek out cancer cells by looking for certain proteins on the cells’ surface.

The aim of this trial was to find out how well blinatumomab worked for people who had MRD.

Summary of results

The trial team found that blinatumomab worked well for people who had minimal residual disease after chemotherapy for ALL. Although some of the side effects were quite bad.

About this trial

This phase 2 trial took place worldwide. 116 people joined the trial. Everyone had blinatumomab. They had up to 4 cycles of treatment.

Results

Researchers looked to see if there were any leukaemia cells left in the bone marrow or the blood after blinatumomab. To do this, everyone had a bone marrow test and a blood test.

They had the results for 113 people. They found:

88 people had no leukaemia cells - they were MRD negative after 1 cycle
2 people had no leukaemia cells - they were MRD negative after 2 cycles
23 people had leukaemia cells after treatment - they were still MRD positive

The trial team looked at whose leukaemia hadn’t come back. This analysis included 110 people. At 18 months, this was just over 5 out of every 10 people (54%).

The researchers also looked at how long people lived after treatment. On average this was about 36 months.

Side effects

84 people had a serious side effect. These included:

high temperature (fever)
headache
a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
problems with the central nervous system such as tremors, dizziness or confusion
liver changes

36 people had their treatment interrupted due to side effects. This was mainly due to flu-like symptoms and problems such as tremors or dizziness. Most of these problems resolved quickly after stopping blinatumomab for a short time.

Conclusion

The trial team found that blinatumomab worked well for people who had minimal residual disease after chemotherapy. In most people, it got rid of the MRD. This reduced the risk of the leukaemia relapsing. And increased the length of time people lived.

Where do these results come 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 Open a glossary item

) 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.