Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial of rituximab with chemotherapy for children and teenagers who have B cell lymphoma or leukaemia (Inter-B-NHL Ritux 2010)
This trial is looking at a drug called rituximab alongside chemotherapy for B cell lymphoma or leukaemia in children and young people. The trial is supported by Cancer Research UK.
Children and young people up to the age of 18 can take part in this trial. We use the term ‘you’, but of course if you are a parent, we are referring to your child.
More about this trial
One way of classifying non Hodgkin lymphoma and certain types of
Doctors treat B cell lymphoma and leukaemia in children with chemotherapy. This often works well, but researchers are looking for ways to improve treatment. In this trial, they are looking at a drug called rituximab.
We know from research that adding rituximab to chemotherapy can improve the treatment of certain types of B cell lymphomas in adults. In this trial, the researchers want to see whether adding rituximab to standard chemotherapy will improve the treatment for children and teenagers
There are 2 parts to the trial. The 1st part is for children and young people who have a type of non Hodgkin lymphoma that starts in
The 2nd part of the trial is for children and young people who have a B cell lymphoma such as Burkitt’s lymphoma or diffuse large B cell lymphoma. Children with a type of leukaemia called Burkitt type acute lymphoblastic leukaemia can also take part.
The aims of the trial are to
- See if adding rituximab to chemotherapy improves treatment for B cell lymphomas and leukaemia in children and young people
- Learn more about any long term risks of rituximab for these patients
Who can enter
You may be able to join the 1st part of this trial if you have a type of B cell lymphoma called primary mediastinal B cell lymphoma and it has not spread to your brain or spinal cord. Please note the 1st part of this trial has now closed.
If you have lymphoma, you must be in 1 of the following situations
- Your lymphoma is in
lymph nodeson both sides of your diaphragm (stage 3) and there is a high level of a substance called LDH in your blood
- Your lymphoma has spread outside your lymph nodes (stage 4)
As well as the above, the following must apply
- You are at least 6 months old but have not yet reached your 18th birthday
- If you are sexually active, you are willing to use reliable contraception during the trial and for up to a year afterwards if there is any chance you or your partner could become pregnant
You cannot join this trial if any of these apply. You
- Have follicular lymphoma, MALT lymphoma or nodular marginal zone lymphoma
- Have lymphoma that does not have a protein called CD20 on the cells (the trial team will test for the CD20 protein and if the test is negative you won’t be able to join the trial. If they can’t get a result for some reason, you may be able to take part)
- Have had an organ transplant or have other problems with your immune system (the trial team can advise you about this)
- Have already had rituximab
- Have had any other type of cancer
- Are having an experimental treatment as part of another clinical trial
- Are known to be HIV or hepatitis B positive
- Have a serious viral infection
- Are pregnant or breastfeeding
The researchers need 40 children and young people to join the 1st part of the trial and 600 to join the 2nd part. The 1st part of this trial has now closed.
In the first part of the trial, everybody had rituximab alongside chemotherapy.
When it started the 2nd part of the trial was randomised. The people taking part were put into treatment groups by a computer. Half the people taking part had chemotherapy and rituximab. The other half had chemotherapy alone. Now everybody in the 2nd part of this trial is having chemotherapy and rituximab.
In this part of the trial, the chemotherapy you have will depend on the type of lymphoma or leukaemia you have. There are 3 different chemotherapy treatment plans which include some or all of the following drugs
The trial team will give you more information about which of these drugs you will have and when you have them. Depending on the chemotherapy plan you have, the treatment will last 4 or 6 months.
You have rituximab 6 times during your chemotherapy. You have it through a drip into a vein. It takes a few hours each time.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Bone marrow test
- Lumbar puncture
- CT scan
- Ultrasound scan
- Heart scan (
You see the trial doctors regularly during your chemotherapy. They will explain which other tests and scans you need to have during your treatment.
When you finish treatment, you see the trial team once a month for the first year, every 3 to 6 months for the next 2 years and then once a year for 2 years after that.
The side effects of the chemotherapy drugs in this trial include
- Hair loss
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Sore mouth
- Tummy (abdominal) pain
The side effects of rituximab include
- Feeling sick
- Tummy pain
- Indigestion and loss of appetite
- Night sweats
- Skin rash
- Low blood pressure
- A drop in the number of white blood cells causing an increased risk of infection
Occasionally, people have a reaction to rituximab causing a fever, chills and shivering (rigors), a headache and feeling sick. If this happens, the trial team will slow down or stop the drip.
Rituximab has been linked to a rare viral infection in the brain called PML or progressive multifocal leukoencephalopathy. The trial doctor will monitor you very carefully for any signs of PML.
We have more information about the side effects of
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.
Dr Amos Burke
Alex Hulme Foundation
Cancer Research UK
University of Birmingham
This is Cancer Research UK trial number CRUK/11/038.