
"He went through six operations and was placed on a clinical trial so he could try new treatments.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is for children and young adults whose cancer has come back after treatment (relapsed) or continued to get worse during or after treatment (refractory).
This trial is for children and young people up to and including the age of 25. We use the term 'you' in this summary, but if you are a parent, we are referring to your child.
Venetoclax is a . It works by blocking a certain protein that cancer cells need to stay alive.
Doctors in the UK use venetoclax to treat adults with chronic lymphocytic leukaemia (CLL).
Researchers want to find out if it can help children and young adults with cancer when their cancer comes back or has continued to get worse during treatment.
The aims of the study are to find out:
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.
Who can take part
You may be able to join this study if all of the following apply. You:
Please note depending on what type of cancer you have there are other entry conditions that apply for you to join. Your doctor will talk to you about these.
Who can’t take part
You cannot join this study if any of these apply.
Cancer related
You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is an international phase 1 study. The team need 10 children and young people from the UK to join and they need 165 worldwide to join.
Venetoclax is a tablet. Your doctor will tell you how many venetoclax tablets to take.
There are 2 types of tablet:
You have tablets you swallow whole if you can do so. You take them once a day with a glass of water. You take the tablets within 30 minutes of eating a meal. You cannot chew, crush or breakup the tablets.
For those who cannot swallow whole tablets you have venetoclax tablets that you dissolve in water, grape juice or apple juice. You take these tablets once a day within 60 minutes of eating a meal.
You might stay in hospital for 2 or 3 days when you start taking venetoclax. This is so your doctor can monitor you. During this time the doctor increases the dose of venetoclax to find the best dose for you.
You might have chemotherapy with venetoclax. Depending on your cancer this might start any time after having 3 or 4 doses of venetoclax. You will stay in hospital for at least a day if you start chemotherapy. This is so the doctor can monitor you.
You continue to have venetoclax as long as it is still working.
Diary and questionnaire
You have a diary to write down:
For those who are having the tablets that dissolve you fill in a questionnaire during treatment at:
The questions ask:
Samples for research
What tests you have will depend on your cancer type. The study team will take an additional sample if you have any of these tests:
The team use these samples:
You see the doctor to have tests before taking part. These tests include:
During treatment you see the doctor often for the first 3 months. You then see then see them every 3 months for the rest of the time you’re having treatment and at the end of treatment.
After you have finished treatment the study doctor will phone you every 3 months for 5 years. This is to see how you are and if you are having any other treatment. You do not have to agree to this.
Extra tests
Depending on your cancer type you might also have one or more of the following:
You have these:
Your doctor will tell you which extra tests you have and when you have them.
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The common side effects of venetoclax include:
Your doctor or a member of the study team will talk to you about the possible side effects of venetoclax before you agree to join the study.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Quentin Campbell-Hewson
AbbVie
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"He went through six operations and was placed on a clinical trial so he could try new treatments.”