A trial looking at acute lymphoblastic leukaemia that has not responded to treatment or has come back (Alcantara Study)

Cancer type:

Acute leukaemia

Acute lymphoblastic leukaemia (ALL)

Blood cancers

Leukaemia

Status:

Results

Phase:

Phase 2

This trial looked at a drug called blinatumomab for acute lymphoblastic leukaemia that has come back after or continued to get worse during treatment.

This study was for people with acute lymphoblastic leukaemia (ALL) that has the Philadelphia chromosome Open a glossary item .

More about this trial

The usual treatment for acute lymphoblastic leukaemia (ALL) is chemotherapy. Some people might have a type of targeted drug called a tyrosine kinase inhibitor such as imatinib or dasatinib. But these targeted drugs don’t work for some people and their ALL gets worse or comes back after treatment.

When the researchers did this trial, blinatumomab was a new drug. Doctors thought it might help people with ALL who’d already had a tyrosine kinase inhibitor (TKI).

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

The aims of this trial were to find out:

how well blinatumomab works for acute lymphoblastic leukaemia that has the Philadelphia chromosome
more about the side effects

Summary of results

The trial team found that blinatumomab worked for some people with ALL whose TKI treatment hadn’t worked. And the side effects were manageable.

45 people took part in this small phase 2 trial.

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 Open a glossary item

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 Open a glossary item

. 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 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.