“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at treatment for acute promyelocytic leukaemia (AML 19)
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.
Before January 2019 everyone in this trial had the same treatment. People now have one of two treatments depending on the risk of your APL coming back.
When a leukaemia comes back it is called relapse. Your doctor uses a number of factors to work out your risk. They look at samples of your blood and bone marrow as well as looking at the chromosomes in your leukaemia cell (cytogenetics).
The aims of this trial are to find the best treatment for people with standard risk and high risk APL.
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
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).
Standard risk APL
If you have a standard risk of your APL coming back you have 2 drugs called
You have tretinoin as tablets every day for about 60 days. You have arsenic trioxide drip into a vein every day for the first 5 days. Then twice a week for the next 7 weeks.
This is the 1st course of treatment. You then have further treatment with tretinoin and arsenic trioxide for about 6 months. Your medical team will tell you when and how often you have these drugs.
High risk APL
If you have high risk APL, you have treatment called AIDA. This includes the drugs
- Tretinoin (ATRA)
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. Your medical team will tell you when and how often you have these drugs.
You then finish treatment as part of this trial. Your doctor will discuss further appointments and treatment with you.
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.
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
- Sore mouth
- Loss of appetite
We have more detailed information about
How to join a clinical trial
Professor Nigel Russell
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/13/35