A trial looking at treatment for acute promyelocytic leukaemia (AML 19)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at treatment for a type of acute myeloid leukaemia called acute promyelocytic leukaemia (APL). It is for people who are fit enough to have treatment. This trial is supported by Cancer Research UK.
More about this trial
The treatment of acute promyelocytic leukaemia (APL) is part of a larger trial looking at many different treatments for other types of AML (not APL) and high risk Myelodysplastic syndromes (MDS). High risk MDS may develop into AML over time.
The treatment for people with other types of AML and MDS is explained in A trial looking at different treatments for acute myeloid leukaemia and high risk myelodysplastic syndromes.
Everyone with APL in this trial has the same treatment. This treatment was looked at in an earlier trial and worked very well.
Everyone is followed closely by their doctor during and after their treatment. Doctors also want to see what effect your treatment and monitoring has on your quality of life.
Who can enter
The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.
You may be able to join this trial if all of the following apply. You
- Have acute promyelocytic leukaemia (APL)
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
- Are aged over 16 years
- Are willing to use reliable contraception during treatment and for 1 month afterwards if there is any chance that you or your partner could become pregnant
You cannot join this trial if any of these apply. You
- Have certain heart problems
- Have problems with numbness and tingling in your hands and feet (peripheral neuropathy) unless this is only mild
- Have any other cancer that needs treatment
- Are HIV (Human Immunodeficiency Virus) positive
- Are pregnant or breastfeeding
Trial design
This is a phase 3 trial. The researchers need 3000 people to join the whole of the AML 19 trial (including people with AML and high risk MDS).
In this trial you have treatment called AIDA. This includes the drugs
You have tretinoin as tablets every day for 60 days. You have idarubicin through a drip into a vein on 4 different occasions over a period of about 1 week.
This is the 1st course of treatment.
You have 3 further courses of AIDA, each about 1 month apart. For these courses you have
- Tretinoin tablets twice a day, every day for 15 days
- 4 or 5 treatments with idarubicin (or a similar drug) over a period of 7 days
Everyone having AIDA will be asked to fill out a questionnaire at the start of treatment and on 2 more occasions during treatment. This will ask you about your quality of life.
You then finish treatment as part of this trial. Your doctor will discuss further appointments and treatment with you.
Hospital visits
You will see the doctors and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination
- Bone marrow test
You have the above tests again during and after your treatment.
You may be able to have some of your treatment as a day patient, so you go home the same day. You still need to go to hospital quite often (for example 2 to 3 times a week) to see a doctor, have tests and have your treatment, if it is due.
Your doctor or nurse will explain how often you need to visit hospital during and after your treatment.
Side effects
The most common side effects of treatment with AIDA includes
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Tiredness (fatigue)
- Hair loss
- Diarrhoea
- Constipation
- Sore mouth
- Loss of appetite
We have more detailed information about
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.
Chief Investigator
Professor Nigel 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/13/35
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
