"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study of gemtuzumab ozogamicin with chemotherapy for children with AML (MyeChild01)
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
- acute myeloid leukaemia (AML)
- high risk myelodysplastic syndrome (MDS)
- an isolated myeloid sarcoma (granulocytic sarcoma)
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 marrowcan’t make blood cells (bone marrow failure syndromes)
- have already had treatment with chemotherapy or a
biological therapythat could affect you taking part in this study for example previous treatment with an anthracycline chemotherapy drug such as doxorubicin, epirubicin or daunorubicin
- are pregnant or breastfeeding
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.
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.
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.
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.
- 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.
- a drop in blood cells causing an increased risk of infection, bruising or bleeding
- sore mouth
- a change to the way your liver works
Your doctor will talk to you about the side effects before you agree to take part.
How to join a clinical trial
Professor Brenda Gibson
Cancer Research UK
University of Birmingham