A trial looking at daratumumab and standard treatment for children and young adults with acute lymphoblastic leukaemia or lymphoblastic lymphoma (Delphinus trial)

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. 

Who can take part
You might be able to join if you have:

• T cell ALL or LL that has come back after the first treatment or treatment has stopped working 

As well as the above, the following must also apply. 

• More than 5 out of every 100 cells (5%) in the bone marrow are made up of immature blood cells (blasts) or there is a tissue sample confirming the diagnosis and the doctor can measure the ALL or LL on a scan. 
• You can care for yourself but can’t carry on with all your normal activities or do active work (Karnofsy scale 70 or more) or your child can't play as actively  as normal and spends less time than usual in play activity (Lansky scale of 70 or more).
• You have satisfactory blood test results. 
• Teenagers and young adults who are sexually active must be willing to use reliable contraception during treatment and for 6 months to 1 year afterwards if there is any chance they or their partner could become pregnant. 

Who can’t take part
You cannot join this trial if any of these apply. 

Cancer related
You:

• were diagnosed with leukaemia under the age of 1
• have had a transplant with somebody else’s cells (allogeneic transplant ] in the last 3 months
• have had treatment to damp down your immune system  after a stem cell transplant within 1 month of joining the trial
• ALL that is Philadelphia positive  and this means you are suitable to have a treatment with a tyrosine kinase inhibitor drug  such as imatinib
• have T cell ALL or LL and you have already had a lot of treatment with the chemotherapy drug doxorubicin
• have a condition where the cells from your stem cell transplant are attacking your own cells (Graft versus Host Disease  or GvHD) and this is causing moderate to severe symptoms 
• have already had daratumumab or a similar drug in the past
• have had immunotherapy such as CAR T-cell therapy within 4 weeks of joining the trial or a drug called blinatumomab within 2 weeks
• have had an experimental drug or used an experimental device within 4 weeks of having the first dose of daratumumab

Medical conditions
You:

• have shortness of breath at rest, low levels of oxygen or moderate to severe asthma 
• have Down’s syndrome  or certain other conditions such as Fanconi anaemia or any other bone marrow failure syndrome
• have a heart trace (ECG) that shows a slow heart rhythm (severe QT prolongation)
• have had major surgery within 2 weeks of joining the trial or you haven’t fully recovered from surgery
• have HIV
• have an active hepatitis B or hepatitis C infection
• have any other medical condition or mental health problem that the trial team think would affect you taking part

Other
You:

• are allergic to any of the drugs used in the trial
• have had a live vaccine  within 4 weeks of the first dose of the trial drug
• have a problem with drugs or alcohol or any other problem that might affect your ability to stick to the trial visits
• are pregnant, breastfeeding or planning to become pregnant within 12 months after the last dose of daratumumab 
• are a sexually active male and planning to father a child within 6 months after the last dose of daratumumab