A trial looking at nemtabrutinib, ibrutinib or acalabrutinib for chronic lymphocytic leukaemia or small lymphocytic lymphoma (BELLWAVE-011)

The following bullet points are a summary of 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. 

Who can take part

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

• have CLL or SLL that needs treatment. Your doctor will know this. 
• have swollen lymph nodes  that measure more than 1.5cm across on a CT or MRI scan, the number of platelets  or red blood cells  in your blood is getting lower or the number of white blood cells  in your blood is getting higher. Your doctor will know this. 
• have changes in the TP53 gene or part of chromosome 17 is missing (deleted). Your doctor will know this. 
• can swallow medication and keep it down 
• have satisfactory blood test results 
• are up and about for at least half the day. You can look after yourself but might not be able to work (performance status of 0, 1 or 2). 
• are willing to use reliable contraception during the trial and for a time after if there is any chance you or your partner could become pregnant 
• are at least 18 years old 

Who can’t take part

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

• have already had cancer treatment that reaches the whole body (systemic cancer treatment ) for CLL or SLL 
• have Richter’s syndrome or Richter’s transformation. Your doctor will know this.
• have CLL or SLL that has spread to the brain or spinal cord 
• have had recent radiotherapy or any radiotherapy side effects that need steroid treatment . You can take part if you had radiotherapy to help with symptoms and it wasn’t treatment to the brain.
• are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 4 weeks of being put into a treatment group for this trial.
• have had another cancer in the last 2 years unless it has been successfully treated and there have been no signs of it since. You can join if you have non melanoma skin cancer  or carcinoma in situ . This doesn’t apply if you have CIS of the bladder. 

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

• have a problem with your digestive system (gut) that means you can’t absorb medication 
• have a problem with your heartbeat. The trial team check if you have a heart condition before you join the trial. 
• have a severe bleeding problem 
• have a problem with how your immune system  works or you have had treatment that damps down the immune system. This includes steroid treatment within 2 weeks of starting trial treatment unless it was a low dose.
• have an autoimmune condition  that needed treatment in the last 2 years apart from certain ones. Your doctor will know about this. 
• are taking medication that affects body substances called CYP enzymes. Your doctor will know this. 
• have HIV unless you are having treatment and it is under control. You can’t take part if you have HIV and you developed an illness that occurs more often and is more severe in people with HIV.
• have active hepatitis B or hepatitis C unless you have had or are having treatment and it is under control or you have another active infection that needs treatment
• have had major surgery and you aren’t better yet
• have any other medical condition or mental health problem that could affect you taking part in the trial

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

• are pregnant or breastfeeding 
• are allergic to nemtabrutinib or you can’t have ibrutinib or acalabrutinib for any reason 
• have had a live vaccine  within 30 days of starting trial treatment. Please note that the COVID-19 vaccine is allowed as it isn’t a live vaccine.
• have a problem with drugs or alcohol