A study looking at venetoclax for children and young adults with cancer

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:

• have cancer that has come back after treatment (relapsed) or continued to get worse during treatment (refractory) 
• have satisfactory blood test results 
• are under 16 years old and might not play as actively as before your cancer but take part in quiet play and activities (Lansky performance score 50 and above) or are over 16 years old and you might need quite a lot of help to care for yourself (Karnofsky performance score 50 and above)
• are willing to use contraception if you are a woman who is sexually active while having venetoclax and for 30 days after your last venetoclax dose if there is any chance you could become pregnant. If you have chemotherapy with venetoclax your doctor will tell you how long after your last treatment you need to continue using contraception.
• are willing to use contraception if you are a man who is sexually active while having venetoclax and for 90 days after the last dose if there is any chance your partner could become pregnant. If you have chemotherapy with venetoclax your doctor will tell you how long after your last treatment you need to continue using contraception.  You are also willing not to store your sperm while having treatment.
• are younger than 25 years old

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:

• have cancer that started in the brain (primary brain tumour)
• have cancer that has spread to the brain
• need to have radiotherapy to your head due to disease of the central nervous system (CNS)
• have had a monoclonal antibody (MAB) including inotuzumab ozogamicin within 30 days of starting treatment
• have had an immunotherapy treatment called adoptive cell therapy  for example CAR-T cell therapy within 30 days of starting study treatment
• have any other cancer treatment including blinatumomab within 2 weeks of starting study treatment unless you have acute lymphoblastic leukaemia (ALL) with the Philadelphia chromosome  change and you were taking a tyrosine kinase inhibitor  (TKI) when asked to join the study
• are taking steroids to treat your cancer unless you have stopped taking them at least 5 days before starting study treatment 
• are taking hydroxycarbamide (hydroxyurea) unless you can stop taking while in the study
• had a bone marrow transplant  less than 100 days ago 
• had a bone marrow transplant more than a 100 days ago and have active graft versus host disease  (GvHD) or you are still taking medication after the transplant to damp down your immune system  within 7days of starting study treatment
• have neuroblastoma and had a type of radiation therapy called MIBG less than 6 weeks ago

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

• have hepatitis
• have an active infection. If you had a COVID-19 test or have been in contact with someone who had COVID-19 or someone who has symptoms of COVID-19 you must have at least 2 tests showing you don't have COVID-19 before joining the trial. 
• have ongoing moderate to severe side effects from previous treatment
• have problems with your digestive system  that affects how well you absorb medication into your body
• had medication that affects the CYP enzymes within 7 days of starting study treatment

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

• had fruits such as grapefruit, grapefruit juice, Seville oranges including marmalade and star fruit within 3 days of starting study treatment
• are pregnant or breastfeeding