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

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Leukaemia

Status:

Results

Phase:

Phase 2

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

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 Open a glossary item.

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

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 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.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Alan Burnett

Supported by

Bioenvision Limited
Experimental Cancer Medicine Centre (ECMC)

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 389

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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