A trial looking at selumetinib and dexamethasone for acute lymphoblastic leukaemia (SeluDex)

The following bullet points list 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.

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

• have acute lymphoblastic leukaemia (ALL) that has come back after treatment or got worse during treatment. If you are 18 years or older you must have had at least 1 treatment already, if you are younger than 18 years old you must have had 2 treatments already. If you have B cell ALL you must either have had CAR T cell therapy, be waiting to have CAR T cell therapy or not able to have CAR T cell therapy.
• have ALL that has a gene change in the RAS-pathway, you will have a test for this as part of the trial
• have ALL that has come back or got worse after a stem cell transplant that was more than 100 days ago and you have no sign of graft versus host disease and you have stopped taking medication to damp down your immune system for at least a week
• have ALL that has come back or got worse after having CAR T cell therapy and it has been at least 4 weeks since you had the CAR T cells
• have satisfactory blood test results
• are at least able to be up and about for half the day and can look after yourself (performance status 0 to 2) if you are 18 years or older or you are at least up and about for most of the time, active play is minimal but you can mostly take care of yourself (Lansky play scale 60 or more; Karnofsky performance score 60 or more) if you are younger than 18 years old
• need to be a certain size to take part (your doctor will work this out)
• are willing to use reliable contraception during treatment and for at least 4 weeks afterwards for women and 12 weeks afterwards for men if there is any chance you or your partner could become pregnant
• are able to swallow the selumetinib capsules whole

You cannot join this trial if any of these apply.

Cancer related
You:

• have ALL that doesn’t have the gene change in the RAS-pathway
• have mature B cell leukaemia
• have ALL that has the Philadelphia chromosome
• still have moderate to severe side effects from any previous anti cancer treatment apart from hair loss
• have had an anti cancer drug that works in a similar way to selumetinib
• have had an experimental drug as part of a clinical trial or any other anti cancer treatment (apart from dexamethasone and hydroxycarbamide) that affects your whole body (systemic treatment) within the 4 weeks of joining the trial (6 weeks for nitrosoureas, suramin and mitomycin)
• have had radiotherapy within 4 weeks of joining the trial or within 7 days of starting your treatment if it is a small area of radiotherapy for relief of pain (palliative) 
• have any other cancer that your doctor think could affect you taking part

Medical condition
You:

• have severe heart problems such as angina, heart failure or your heart isn’t working well enough
• have or had eye problems such as an increased pressure in the eye, a blocked vein in the eye or glaucoma that isn’t controlled by medication
• have had major surgery within 4 weeks of joining the trial apart from surgery to put in a central line or similar device
• are allergic to selumetinib, dexamethasone, any of their ingredients or any similar types of drug
• have any problems with your digestive system, such as uncontrolled vomiting, irritable bowel syndrome or bowel surgery, that would affect how you absorb tablets or capsules
• have HIV, hepatitis B or hepatitis C
• have kidney problems or have had a kidney transplant
• have an infection needing treatment
• have a bleeding problem that isn’t controlled
• have any other medical or mental health condition that could affect you taking part

Other
You:

• are pregnant or breastfeeding