A study of gemtuzumab ozogamicin with chemotherapy for children with AML (MyeChild01)

Cancer type:

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

Status:

Open

Phase:

Phase 3

This study is to find how many doses of gemtuzumab ozogamicin (Mylotarg) to give with chemotherapy for children with acute myeloid leukaemia (AML). 

This summary is 1 of 3 summaries of the MyeChild01 trial. 

To take part in this study you must have agreed to join the improving chemotherapy for AML part of the MyeChild01 trial.

Further in your treatment if you are suitable, you might be asked to take part in the stem cell transplant part of the trial. . 

Cancer Research UK supports this study and 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

Doctors treat AML with chemotherapy to get rid of the leukaemia cells. This is called induction chemotherapy. But the amount of chemotherapy can be limited because of a risk of damaging the heart. 

Mylotarg is a biological therapy called a monoclonal antibody. Researchers want to add it to induction chemotherapy. They hope it can help without increasing the risk of damage to the heart. 

The aim of this study is to find the safest number of doses of Mylotarg to give with induction chemotherapy. 

The researchers will then use the best number of doses in another part of the MyeChild01 trial.

Who can enter

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

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

And all of the following must apply

  • your heart works well enough, your doctor will 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

You cannot join this study 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 drug such as doxorubicin, epirubicin or daunorubicin 
  • have Down’s syndrome Open a glossary item
  • are pregnant or breastfeeding 

Trial design

This is a dose finding study. The study team need about 62 children and young people to join. 

Researchers want to find the safest number of doses of Mylotarg to give with your induction chemotherapy. Depending on when you join the study you might have 1, 2 or 3 doses of Mylotarg. 

You have Mylotarg as a drip through a central line before having chemotherapy. 

Those having 1 dose have it on the 4th day of chemotherapy.

Those having 2 doses have it the 4th and 7th day of chemotherapy.

Those having 3 doses have it on the 4th, 7th and 10th day of chemotherapy.

Blood samples
The team will ask for up to 11 extra blood samples if you agree to take part. The number they will take depends on how many doses of Mylotarg you have. They will take these using your central line. 

A final sample is taken 1 month after your 1st dose of Mylotarg. 

Researchers will use these samples to find out more about how Mylotarg works in the body. 

Hospital visits

You stay in hospital during your treatment with Mylotarg and afterwards while you are still having chemotherapy. Your doctors can explain how long this is likely to be. 

 

Side effects

Mylotarg is a new drug and there might be side effects we don’t know about yet. The study team will monitor you closely during the time you have the drug. 

Side effects can happen during treatment and after treatment. 

During treatment

  • an allergic reaction 
  • feeling or being sick
  • flu like symptoms 
  • a change in blood pressure which can make you feel faint

You have drugs before and after you have the Mylotarg to reduce the risk of these side effects happening.

After treatment

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

Location

Birmingham
Bristol
Cambridge
Glasgow
Leeds
Liverpool
London
Manchester
Newcastle upon Tyne
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.

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

Last reviewed:

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