A trial looking at ibrutinib and standard treatment for children and young adults with B cell non-Hodgkin lymphoma (SPARKLE)

Cancer type:

Blood cancers
Children's cancers
High grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 3

This trial is for children and young people whose lymphoma has come back or treatment has stopped working.

It is a trial in children and young adults up to the age of 30 who were diagnosed with B cell non-Hodgkin lymphoma under the age of 18. 

We use the term ‘you’ in this summary. But if you are a parent, we are referring to your child.

More about this trial

You might have a combination of chemotherapy and rituximab to treat B cell non-Hodgkin lymphoma that has come back. Or if treatment has stopped working. Usual treatment (standard treatment Open a glossary item) might include 1 of the following combinations:
RVICI is the name of a combination of the drugs that includes:
  • rituximab 
  • vincristine
  • ifosfamide
  • carboplatin
  • idarubicin
RICE is name of the combination of drugs that includes:
  • rituximab
  • ifosfamide
  • carboplatin
  • etoposide
But sometimes these treatments stop working or the lymphoma comes back. So, doctors are trying to improve treatment. In this trial, they are looking at a drug called ibrutinib. 
 
Ibrutinib is a targeted drug called a cancer growth blocker. It stops signals that cancer cells use to divide and grow. Doctors think that adding it to RICE or RVICI will improve treatment. But they aren’t sure, so want to find out more. 
 
The trial is in 2 parts. Part 1 has closed. It looked at the best dose of ibrutinib to have alongside RICE and RVICI. Researchers have found this dose. 
 
Part 2 is open. It is for children and young adults aged between 1 and 30 years old. Everyone has RICE or RVICI. And some have ibrutinib and some don’t. 
 
The aims of the trial are to find out:
  • how safe treatment is
  • if adding ibrutinib to RICE or RVICI improves treatment 
  • more about the side effects

Who can enter

 
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 may be able to join this trial if all of the following apply. 
 
You:
  • have B cell non-Hodgkin lymphoma (NHL) such as Burkitt lymphoma, diffuse large B cell lymphoma (DBCL) or other childhood B cell lymphomas
  • have had your first treatment but the lymphoma has come back, or the standard treatments have stopped working   
  • have an area of lymphoma that measures at least 1cm across on a scan, you have bone marrow involvement or you have lymphoma in the spinal fluid (CSF Open a glossary item)
  • have satisfactory blood test results  
  • need quite a lot of help to care for yourself (Karnofsky performance scale 50 or more) or you get dressed but need to lie down for much of the day and only take part in quiet play and activities (Lansky play scale 50 or more)
  • are willing to use reliable contraception during treatment and for 3 months after the last dose of ibrutinib if you are sexually active and there is any chance you or your partner could become pregnant or for at least 1 year after the last dose of RICE or RVICI
  • are between 1 years old and 30 to join part 2 if you were diagnosed with NHL under the age of 18 
Who can’t take part
 
You cannot join this trial if any of these apply. 
 
Cancer related
You:
  • have had ibrutinib in the past 
  • have had a stem cell transplant in the last 6 months 
  • developed lymphoma after having a stem cell transplant or an organ transplant (this is called post transplant lymphoproliferative disease or PTLD)
  • have had an experimental treatment or device within 30 days of starting trial treatment 
Medical conditions
You:
  • are having treatment to thin the blood such as warfarin 
  • have a problem with how your blood clots
  • you take medication that blocks a substance called CYP3A4/5
  • have problems with your heart, such as an abnormal heart rhythm or it is weak 
  • have a problem with your digestive system Open a glossary item that means you can’t absorb ibrutinib properly
  • have had major surgery within 4 weeks of joining the trial, have surgery planned during the trial or you haven’t fully recovered from an operation
  • 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 pregnant or breastfeeding or planning a pregnancy within 3 months of stopping ibrutinib or within a year of stopping the other drugs in the trial
  • are allergic to ibrutinib, any of the other drugs in the trial or anything they contain

Trial design

This is a phase 3 trial. It is taking place worldwide. The researchers need 96 children and young adults to take part in total. They need 72 people to join part 2 including 7 from the UK. 
 
Part 1
Part 1 is now closed. Researchers looked at the best dose of ibrutinib to have alongside RICE or RVICI.
 
Part 2 
Part 2 is open. This part of this trial is randomised. This means that everyone is put into 1 of the following 2 treatment groups by computer.  Neither you nor your doctor will be able to decide which group you are in. 2 out of every 3 people will have ibrutinib. 
 
You have 1 of the following:
  • standard treatment only (group 1)
  • standard treatment and ibrutinib
    (group 2)
The standard treatments are RICE or RVICI. Your doctor will decide which treatment is best for you.


 
You have treatment in cycles. Each 28 day period is 1 cycle of treatment. You have up to 3 cycles of treatment. This takes about 12 weeks.
 
Standard treatment only (group 1)
You have RICE or RVICI as a drip into a vein. You have these drugs in the first week of each treatment cycle. The trial team will give you the exact timings of these. 
 
Standard treatment and ibrutinib (group 2)
You have RICE or RVICI as a drip into a vein. 
 
Ibrutinib is a capsule or a liquid (suspension). You take this at home once a day, every day. There are certain days that you take your ibrutinib at the hospital. Your doctor will tell you when this applies. 
 
If you take ibrutinib and it works well, you might have 3 more cycles of it. You won’t be able to have this if you had RICE or RVICI only. The trial team can tell you more about this. 
 
Samples for research
You give some extra blood samples and tissue samples during treatment. You give the samples at specific times and the trial team will give you more information about this. 
 
They plan to use the samples to:
  • see how well the treatment is working
  • find out what happens to the drugs in the body
  • look for biomarkers Open a glossary item to predict who will benefit from treatment

Hospital visits

You see a doctor and have some tests before you can take part. These include:
The trial team might also ask you to give a tissue sample (biopsy Open a glossary item) of a lymph node Open a glossary item.  
 
You might need to stay in hospital for up to a week when you have RICE or RVICI. The trial team can tell you more about this. 
 
You stop treatment if it isn’t working. Your doctor will talk to you about other treatment options. 
 
Follow up
When you stop treatment, you see the trial team 1 month later for a check up. They’ll see everyone who had had ibrutinib for a check up after treatment:
  • every 3 months in the first year
  • every 6 months in the second and third year
If you didn’t have ibrutinib you’ll have routine follow up appointments. Your doctor can tell you more about this. 

 

Side effects

Having ibrutinib alongside RICE or RVICI is a new treatment for NHL. So, there may be some side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything. 
 
The most common side effects of ibrutinib include:
  • diarrhoea or constipation
  • muscle pain, bone pain and joint aches
  • feeling or being sick 
  • an increased risk of infection
  • skin rash or skin infections
  • an increased risk of bruising and bleeding
  • high temperatures
  • colds 
  • pneumonia
  • swelling of the hands or feet
  • muscle spasms
  • sores in the mouth 
  • headache
  • high blood pressure
  • sinus infection
You doctor will talk to you about the possible side effects of RICE or RVICI. 
 
We have information about RICE and the possible side effects. We also have information about the drugs included in the combination of RVICI. They are:
  • rituximab
  • vincristine
  • ifosfamide
  • carboplatin
  • idarubicin

Location

Birmingham
Cambridge
Leeds
Liverpool
London
Manchester
Newcastle upon Tyne
Sheffield
Sutton

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Prof Amos Burke

Supported by

Janssen-Cilag Limited

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15661

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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