A trial looking at treatment for acute promyelocytic leukaemia (AML 17)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers




Phase 3

This trial is looking at the treatment for acute promyelocytic leukaemia (APL). This trial is supported by Cancer Research UK.

There are different parts to this trial that are looking at adult acute myeloid leukaemia (AML) and AML in children. There is information about the other parts of the trial listed separately.

This part of the trial is particularly focusing on those who are under 60 years old, although some people over 60 years old may take part. It will compare 2 treatments for APL

The aim is to find out which treatment is better for treating APL.

Who can enter

You can enter this trial if you

  • Have acute promyelocytic leukaemia (APL)
  • Are well enough to be up and about for at least half of the day (performance status 0,1,2)
  • Have satisfactory blood results
  • Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
  • Are at least 16 years of age

You cannot enter this trial if you

  • Have another type of cancer at the same time as your leukaemia
  • Have another serious medical condition including infection, lung disease and heart disease that cannot be controlled by medication
  • Have damage to your nerves (neuropathy Open a glossary item)
  • Are pregnant or breastfeeding

Trial design

This is a large national trial that aims to recruit 2,800 patients, in total, with AML and high risk MDS. About 300 of these patients will have acute promyelocytic leukaemia (APL). It is a randomised trial. Neither you nor your doctor will be able to choose which treatment you have.

There are 2 treatment groups in this trial. Both have an induction course and a consolidation course.

If you are in group 1, you will have ATRA and idarubicin in the induction course.

ATRA is a capsule you take twice a day. After about a month of treatment, you will have a bone marrow test to find out how well it is working. If the leukaemia is not in complete remission Open a glossary item, you continue taking ATRA for a total of 60 days.

You start idarubicin on the second day and have it every other day for a total of 4 doses. You have idarubicin through a drip into a vein over about 20 minutes.

In group 1 the consolidation courses are

  • ATRA twice a day for 15 days and idarubicin on days 1 to 4
  • ATRA twice a day for 15 days and mitoxantrone on days 1 to 5
  • ATRA daily for 15 days and idarubicin on day 1

You have mitoxantrone as a drip into a vein over about 30 minutes.

If you are in group 2, the induction course includes ATRA and arsenic trioxide.

You will be asked to fill in questionnaires before you start treatment and at 3, 6, 12 and 24 months after treatment. They will ask how you are feeling and about side effects you have had. This is called a quality of life study.

If you take part in this trial, the researchers will ask your permission to store some of your blood and bone marrow samples. These samples will be stored safely and may be used in the future for research purposes. Studying these samples may help researchers learn more about leukaemia.

If you don’t wish to have your blood and bone marrow samples stored for research, you don’t have to. You can still take part in the trial.

Hospital visits

Before you start treatment you see the doctor and have various tests. These tests will include blood tests, bone marrow tests and scans.

You will have blood tests before each course of treatment.

You will possibly have a bone marrow test after each course of treatment and then every 3 months for 3 years.

You should be able to have all your treatment as an outpatient in this trial, but it is possible that you may have to come into hospital for some of the treatment through a drip.

Side effects

The most common side effects of the drugs used in this trial are

Idarubicin may turn your urine pink or red because it is coloured red. This may happen about 1 to 2 hours after you have the drug and can last for up to 2 days.

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 A K Burnett
Professor N H Russell

Supported by

Cancer Research UK
Cardiff University
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/08/025.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 2410

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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