A trial looking at different treatments for acute myeloid leukaemia and high risk myelodysplastic syndrome (AML 19)

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
Leukaemia
Myelodysplastic syndrome (MDS)

Status:

Closed

Phase:

Phase 3

This trial is looking at different treatments for acute myeloid leukaemia (AML). 

It is for people who are fit enough to have intensive treatment. 

This trial is supported by Cancer Research UK.

Please note: previous versions of the protocol included people who had a type of blood disorder called myelodysplastic syndromes (MDS). But the new version is only for people who have AML. 

More about this trial

Doctors usually treat AML with chemotherapy and other drugs to get rid of the leukaemia cells (getting it into remission). This first part of treatment is called induction therapy.

If induction treatment is successful, you usually have treatment to lower the chances of the leukaemia coming back. This is called consolidation treatment. Some people may then have a transplant using the stem cells or bone marrow of a donor.

This trial is trying to answer a number of questions about the treatment of AML. These include trying to find out 

  • Which combination of chemotherapy works best in induction treatment 
  • If 1 or 2 courses of consolidation chemotherapy improve treatment for AML 
  • Whether adding a targeted drug can further reduce the risk of the leukaemia coming back
  • Whether extra monitoring of some people is useful in trying to work out who has a higher chance of their leukaemia coming back

If you have a type of AML called acute promyelocytic leukaemia (APL) you have different treatment. This is described in A trial looking at treatment for acute promyelocytic leukaemia (AML 19). This trial is now closed to recruitment. 

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 myeloid leukaemia
  • Have the CD33 protein on the leukaemia cells. The team test your chromosomes Open a glossary item to find this out. This is cytogenetics. Open a glossary item You might be suitable to take part if you have favourable, standard risk or unknown cytogenetics. The trial team can explain this to you in more detail.
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2
  • Are suitable for intensive treatment
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during treatment and for a period of time after if there is any chance that you or your partner could become pregnant
  • Are aged between 16 and 60 years, older people may be able to take part if your doctor thinks you can have intensive treatment (you need to be at least 18 years old if you are going to have a drug called midostaurin)
  • Have the FLT3 gene change on your leukaemia cells if you are going to have midostaurin

You cannot join this trial if any of these apply. You

  • Have already had chemotherapy to treat your AML, you can still take part if you have had hydroxycarbamide, or a similar low dose treatment to control your white blood cells
  • Have acute promyelocytic leukaemia, myelodysplastic syndrome that changed into AML, secondary AML, high risk myelodysplastic syndrome with less than 20% blasts in the bone marrow or newly diagnosed AML with unfavourable gene changes on the leukaemia cells
  • Are in the blast phase of chronic myeloid leukeamia 
  • 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 about 2,000 people in total to join AML19.

In 2020 the team amended the protocol Open a glossary item . For the current version of the protocol they need 250 people to join. There are a number of different treatments described in this trial summary, not all are relevant to your situation. 

Your treatment depends on:

  • The type of leukaemia you have
  • How well your first induction chemotherapy works
  • Certain features of your leukaemia

You have most of your treatment through a drip into a vein. Your medical team will explain your individual treatment in more detail and how and when you have your drugs. 

At different points in the trial, people with AML are put into groups by computer. Neither you, nor your doctors can decide which group you are in. This is called randomisation.

Doctors look closely at the chromosomes in leukaemia cells. This is called cytogenetics. They know that people with an abnormal chromosome will need different treatment to those who don’t have the abnormality.

Treatment for AML that has no chromosomal abnormality (this part of the trial is open)
If your AML does not have a chromosomal abnormality you are put into 1 of 2 groups at random. You have 1 of the following:

  • DA (Daunorubicin and Ara-C) and 1 dose of gemtuzumab ozogamicin (Mylotarg)
  • DA and 2 doses of gemtuzumab ozogamicin

You have treatment over 10 days. This is your first course of induction treatment. The team then look to see if you have a gene change (mutation Open a glossary item) called FLT3 on your leukaemia cells.

People with the FLT3 gene change have a drug called midostaurin. It is a targeted drug. It is a capsule you take by mouth. The team let you know how many to take and how often to take them. You don’t have this treatment if you don’t have the gene change. 

The team look at samples of your blood and bone marrow to look at factors such as the cytogenetics of your leukaemia. This helps to decide the risk of your leukaemia coming back (relapse).  

If you have high risk disease your doctor decides the best treatment you should have. This might be a stem cell transplant. But this won’t be as part of the trial. If you don’t have high risk AML you continue with treatment as part of the trial. 

Not high risk AML (this part of the trial is open)
If you do not have high risk disease, you have a second course of induction chemotherapy. This will be DA. 

People with the FLT3 gene change have more midostaurin. The trial team let you know how many capsules to take and how often to take them. 

The team then look at blood and bone marrow samples to work out:

  • if you have any leukaemia cells left behind (minimal residual disease)
  • your risk of the AML coming back 

If you have high risk disease then you stop treatment as part of the trial. If your leukaemia isn’t high risk have you have consolidation treatment. Your consolidation treatment is 2 courses of high dose Ara-C. 

People with the FLT3 mutation might have more midostaurin after consolidation treatment. The team let you know how long to take this for. 

You have tests during consolidation treatment to check if your AML has become high risk. You might need to have some treatment that isn’t part of the trial. Your doctor will talk to you about this if it applies. 

Extra monitoring randomisation (closed to recruitment)
If you joined the trial after the closure, you will not be part of this randomisation. You have close monitoring as part of your routine care

Groups closed to recruitment
The following groups are also part of this trial but have now closed to recruitment:

  • treatment for AML that has a chromosomal abnormality
  • high risk AML 
  • extra monitoring randomisation 

Quality of life 
The trial team ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.

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.

Your treatment is very intensive and so you will spend a lot of time at hospital. You usually stay in hospital to have your chemotherapy, for at least 1 to 2 weeks each time, sometimes longer. 

If you are able to have your treatment as an outpatient, you will need to go to hospital quite often (for example 2 to 3 times a week) to have blood tests and to check how you are. 

If you were having treatment that wasn’t part of this trial you would have a similar number of hospital visits as part of your routine care. 

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 chemotherapy include

Mylotarg is a new drug and there might be side effects we don’t know about yet. The trial team monitor you closely during the time you have the drug. It can sometimes cause:

  • infusion reactions which can cause fever and chills - you might have some drugs before you have Mylotarg  to prevent this
  • changes to the way your liver works – you  have regular blood tests to check this

The most common side effects of  Midostaurin include:

  • feeling sick
  • a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness 

Your doctor will talk to you about the side effects before you agree to take part.

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 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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11756

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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