A trial of clofarabine for older people with acute myeloid leukaemia (AML) who cannot have intensive treatment (BIOV-121)

This trial was looking at a new chemotherapy drug called clofarabine, to see how well it worked for older people who could not have intensive treatment for their acute myeloid leukaemia (AML).

Doctors often treat acute myeloid leukaemia (AML) with chemotherapy and possibly a bone marrow or stem cell transplant. But this treatment is very intensive, and people often have serious side effects. Because of this, people are not always fit enough to have intensive treatment.

Clofarabine is quite a new chemotherapy drug. It is similar to other drugs called fludarabine and cladribine. Doctors hoped that clofarabine would be useful for treating older people with AML who were not able to have more intensive treatment. But they were not sure how well it would work.

The aims of this trial were to find out

How well clofarabine worked for older people with AML who were not able to have more intensive treatment
More about the side effects

Recruitment

Start 01/06/2004

End 14/11/2005

Phase

Phase 2

Summary of results

The trial team found that clofarabine worked well for older people with acute myeloid leukaemia (AML) who are not able to have intensive treatment.

Everyone taking part in this trial had clofarabine.

Of the 106 people recruited, 51 had no sign of AML in their blood tests after treatment. This is called a complete remission.

Overall the average amount of time people lived was 19 weeks. For people who had a complete remission the average amount of time they lived was 45 weeks.

The most common side effects were

A drop in white blood cells causing an increased risk of infection
Kidney problems
Liver problems

The researchers concluded that clofarabine worked well for older people with AML who could not have intensive treatment. And that it was well tolerated with few side effects. Researchers are now trying to find out if clofarabine is better than other treatments for older people with AML in trials such as AML 16.

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) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.