A trial of barasertib and low dose cytosine arabinoside for acute myeloid leukaemia in older people (The SPARK study)

Cancer type:

Acute leukaemia

Acute myeloid leukaemia (AML)

Blood cancers

Leukaemia

Status:

Results

Phase:

Phase 2

This trial was comparing a drug called barasertib (also known as AZD1152) with a low dose of cytosine arabinoside chemotherapy for people over 60 who had acute myeloid leukaemia (AML) and couldn’t have intensive treatment.

Doctors usually treat AML with chemotherapy. Treatment that aims to get rid of all the leukaemia cells in your blood and bone marrow Open a glossary item is called induction treatment. It is quite intensive treatment and is not suitable for everyone.

People who are less fit, or who have other medical problems may have less intensive treatment. One of the treatments doctors use is a low dose of the chemotherapy drug cytosine arabinoside. This treatment is known as LDAC. It helps some people, but researchers were looking for ways to improve treatment.

In this study they were looking at a drug called barasertib. It targets a substance called aurora kinase. This is a protein involved when cells divide and grow. Researchers hoped that barasertib would switch off the activity of aurora kinase and stop leukaemia cells growing.

The aim of the study was to see if barasertib worked better than low dose cytosine arabinoside for older people who couldn’t have intensive treatment for AML.

Summary of results

The trial team found that leukaemia responded to treatment in more people who had barasertib than people who had low dose cytosine arabinoside.

The trial recruited 77 people over 60 years of age who had acute myeloid leukaemia and were not fit enough to have intensive treatment. Their average age was 76. The researchers put 74 of the people into 1 of 2 treatment groups at random.

48 people had barasertib
26 people had low dose arabinoside (LDAC)

Everybody had 4 week cycles of treatment.

People having barasertib had it through a drip into a vein via a small portable pump, over 7 days. Then they had 3 weeks without treatment.

People having LDAC had it as an injection under the skin (subcutaneous injection) twice a day for the first 10 days of each treatment cycle. They then had 2½ weeks with no treatment.

The researchers looked at the number of people whose leukaemia completely disappeared (a complete response). They found this was

17 out of 48 people who had barasertib (35%)
3 out of 26 people who had LDAC (12%)

The percentage of people who had serious side effects was higher in the barasertib group. The most common side effects were

But overall, side effects got better and only led to the dose being reduced or treatment being stopped in a small number of people in both treatment groups.

In this trial, having barasertib improved the response rate when compared to low dose cytosine arabinoside. But the pharmaceutical company who ran this trial have told us that further development of barasertib is on hold and it is not currently available as a treatment option.

We have based this summary on information from the team who ran the trial. 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. We have not analysed the data ourselves.