
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
This trial was for people whose acute myeloid leukaemia had not responded to treatment or had come back after the first treatment.
Chemotherapy is one of the usual first treatments for acute myeloid leukaemia (AML). But sometimes, the treatment doesn’t work or the leukaemia comes back. When this trial was done, doctors weren’t sure of the best way to treat this. So researchers were looking at new treatments.
In this trial, they looked at a new chemotherapy drug called vosaroxin. They wanted to see how well it worked alongside a standard chemotherapy drug for AML called cytarabine.
The trial compared the following treatments:
The aims of the trial were to:
The trial team found that on average, there was no benefit to adding vosaroxin to cytarabine. It did not increase the length of time that people lived after treatment (overall survival). However there was some suggestion that it might help people over 60 years old.
711 people with AML took part.
Everyone was put into 1 of 2 groups at .
They looked at how long people lived for after treatment. On average this was:
Although these numbers look different, this difference wasn’t when tested mathematically
The researchers did some more analysis on the results of AML subgroups. These groups were based on;
The researchers found in people over the age of 60, overall survival was:
The researchers say this suggests that adding vosaroxin to cytarabine might help people aged 60 years or older.
They also looked at how well treatment worked. They looked at whose leukaemia went away completely. This is called complete remission. This happened in:
Even though more people had remission with the combination, the number of people who went on to have a was similar in each group. This might be because more people whose AML has come back or stopped responding to treatment are having stem cell transplants than in the past.
People who had vosaroxin had more serious side effects that included:
But the trial team say the side effects were manageable and the increased side effects did not outweigh the benefit of having treatment.
The trial team concluded that there was no difference in overall survival. Although, having vosaroxin and cytarabine might be a useful treatment for people aged 60 years or older.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists () 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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Jonathan Kell
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Sunesis Pharmaceuticals Inc
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”