A trial looking at improving chemotherapy for children with acute myeloid leukaemia (MyeChild01)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Children's cancers
Leukaemia
Myelodysplastic syndrome (MDS)

Status:

Open

Phase:

Phase 3

This trial is looking at using liposomal daunorubicin, mitoxantrone, fludarabine and cytarabine to improve chemotherapy for acute myeloid leukaemia. It is open to children and young people with:

This summary is 1 of 3 summaries of the MyeChild01 trial. We have information on:

Cancer Research UK supports the MyeChild01 trial.

This study is for children and young people who haven’t reached their 18th birthday. We use the term ‘you’ in the summary but if you are a parent we are referring to your child. 

More about this trial

When treating AML with chemotherapy there are 2 stages. The 1st stage is to get rid of the leukaemia cells in the bone marrow. This is called induction chemotherapy. The 2nd stage is to stop it coming back. This is called consolidation chemotherapy. 

The combination of mitoxantrone and cytarabine is one of the standard treatments Open a glossary item used for induction chemotherapy. This works but researchers are always looking for ways to improve treatment. 

One way might be to increase the dose of chemotherapy. But this could increase the side effects caused by the chemotherapy. 

Liposomal daunorubicin is a chemotherapy drug that is very similar to mitoxantrone. It was developed to be given in higher doses without increasing the side effects. But we don’t know if this is the case. So the researchers will compare:

  • mitoxantrone and cytarabine
  • liposomal daunorubicin and cytarabine

High dose cytarabine (HD Ara-C) is one of the standard treatments that doctors use for consolidation chemotherapy. It works but researchers are always looking for new ways to improve consolidation chemotherapy.

They think that the combination of fludarabine and cytarabine might work better as consolidation chemotherapy than HD Ara-C for people who have standard risk of their leukaemia coming back. So they want to compare 

The aims of the trial are to:

  • find which combination is best for induction chemotherapy and compare the side effects 
  • find if fludarabine and cytarabine is better than high dose cytarabine as consolidation chemotherapy to stop leukaemia coming back

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

You may be able to join this trial if all of the following apply. You have one of the following:

And all of the following must apply:

  • your heart works well enough, you will have a test for this
  • you can get dressed but need help with care or can take part in quiet play but need to lie down a lot (Karnofsky performance scale 50 or greater, Lansky performance scale 50 or greater)
  • you have satisfactory blood test results
  • you are willing to use reliable contraception if you are sexually active and there is any chance you or your partner could become pregnant
  • you are under 18 years old

For consolidation chemotherapy part of the trial all of the following must also apply:

  • you have had induction chemotherapy as part of this MyeChild01 trial or you have had 2 courses of mitoxantrone and cytarabine as induction chemotherapy outside of the MyeChild01 trial
  • after induction chemotherapy your risk of AML coming back is either low or average

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

  • have AML that has come back after treatment (relapsed) or continued to get worse during treatment (refractory) 
  • have acute promyelocytic leukaemia (APL)
  • have chronic myeloid leukaemia (CML) that is in blast crisis
  • have a disease where your bone marrow Open a glossary item can’t make blood cells (bone marrow failure syndromes)
  • have already had treatment with chemotherapy or a biological therapy Open a glossary item that could affect you taking part in this study for example previous treatment with an anthracycline chemotherapy drugs such as doxorubicin and idarubicin 
  • have Down’s syndrome Open a glossary item 
  • are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. In the UK the trial team need 300 people to join the MyeChild01 trial. 

Induction chemotherapy
This is a randomised trial. People taking part are put into treatment groups by a computer. Neither you nor your doctor can choose which group you are in. 

The 2 groups for induction chemotherapy are:

•    mitoxantrone and cytarabine
•    liposomal daunorubicin and cytarabine

Diagram for MyeChild01 induction chemotherapy

Before stating treatment you have a central line put in. You have most of your treatment as a drip through the central line. You have the cytarabine as an injection into the fluid around the spinal cord (intrathecal injection Open a glossary item). You have 1 or 2 treatments of induction chemotherapy. 

Everyone has cytarabine twice a day for 10 days.

Those having mitoxantrone have it once a day for 4 days.

Those having liposomal daunorubicin have on the 1st, 3rd and 5th days of treatment.

After the 1st treatment the trial team will assess how well your leukaemia has responded and what the risk is of your leukaemia coming back. 

Those who are at a high risk of their leukaemia coming back are considered for a stem cell transplant. Open a glossary item Your doctor will talk to you about this. 

Those who aren’t at a high risk of their leukaemia coming back have a 2nd treatment to complete their induction chemotherapy. It will be the same as the first. 

After completing your induction chemotherapy the team will again assess the risk of your leukaemia coming back. Those who don’t have a high risk of their leukaemia coming back will have consolidation chemotherapy. Those who have a high risk of their leukaemia coming back will be considered for a stem cell transplant instead. 

You might be asked to join another part of the MyeChild01 trial that is looking at consolidation chemotherapy or stem cell transplants. Your doctor will talk to you about this.  

Consolidation chemotherapy
In the UK the trial team need 180 children and young people to join this part of the trial. 

This part is also randomised. People taking part are put into treatment groups by a computer. Neither you nor your doctor can choose which group you are in. 

The 2 groups are:

  • high dose cytarabine (HD Ara-C) 
  • fludarabine and cytarabine (FLA)

Diagram for MyeChild01 consolidation chemotherapy

You have most of your treatment as a drip into a central line. You have some of the cytarabine as an injection into the fluid around the spinal cord (intrathecal injection).

You have HD Ara-C twice a day on days 1, 3 and 5. 

You have FLA once a day for 5 days. 

Each 5 day period is called a course of treatment. You have 2 courses of treatment. 

Tissue and blood samples
The trial team will ask for extra blood samples and bone marrow samples Open a glossary item. These will be taken at the same time as the routine samples are taken.

They use some of the samples to look at different ways to measure how the leukaemia has responded to treatment. They hope this will help them identify people who are at a greater risk of their leukaemia coming back after treatment. 

They also ask for a sample of cells from the inside of your cheek. They do this by wiping the inside of the cheek with a swab. This is used to look at the DNA Open a glossary item in the cells. They also hope it will help them identify people who are at a greater risk of their leukaemia coming back after treatment. You don’t have to agree to this. You can still take part in the trial.

In the induction part of the trial the researchers also want to find out what happens to mitoxantrone and liposomal daunorubicin in the body. For this they take 8 or 9 extra blood samples over 5 to 7 days from your central line. You don’t have to agree to this. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part. These include:

You have all your treatment (induction and consolidation chemotherapy) as an inpatient in the hospital. 

After your 1st treatment of induction chemotherapy you have the same tests as above apart from the lumbar puncture. 

After you have completed all your treatment you see the doctor:

  • every 3 months for a year 
  • every 6 months in year 2
  • once a year for at least another 3 years

And you have the following tests:

  • a physical examination
  • blood tests
  • an echocardiogram (ECHO) 1, 3, 5 and 10 years after diagnosis

Side effects

The most common side effects of cytarabine, mitoxantrone, fludarabine and liposomal daunorubicin include:

We have more information about 

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

Location

Aberdeen
Belfast
Birmingham
Bristol
Cambridge
Cardiff
Edinburgh
Glasgow
Leeds
Liverpool
London
Manchester
Newcastle upon Tyne
Nottingham
Oxford
Sheffield
Sutton

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 Brenda Gibson

Supported by

Cancer Research UK
Pfizer
University of Birmingham

Other information

This is Cancer Research UK trial number CRUK/14/013.

You can read more information about the trial on the MyeChild01 website

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12053

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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