A trial of rituximab with chemotherapy for children and teenagers who have B cell lymphoma (Inter-B-NHL Ritux 2010)

Cancer type:

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

Status:

Results

Phase:

Phase 2/3

This trial looked at a drug called rituximab alongside chemotherapy for B cell lymphoma in children and young people up to the age of 18. 

The trial was supported by Cancer Research UK. It was open for people to join between 2011 and 2017. The team published the results in 2020.

More about this trial

B cell lymphoma is a type of non Hodgkin lymphoma. When this trial was done, doctors usually used chemotherapy to treat it. Researchers wanted to find out if having rituximab as well would improve treatment.

Rituximab is type of a targeted cancer treatment called a monoclonal antibody. It can recognise and find specific proteins on cancer cells.

We already knew from research that this combination of treatment was useful for adults with certain types of B cell lymphoma. Researchers wanted to find out if this was the case for children.

This trial was for children with types of high grade B cell lymphoma such as Burkitt’s lymphoma and diffuse large B cell lymphoma.

The main aims of the trial were to find out:

  • if adding rituximab to chemotherapy improves treatment for B cell lymphoma in children and young people
  • more about any long term risks of rituximab for these patients

Summary of results

The results showed that rituximab and chemotherapy could be a useful treatment for children and young people with B cell lymphoma.

Trial design
This trial was for children and young people between 6 months and 18 years old, with B cell lymphoma. They hadn’t had treatment before. 

Some people taking part had chemotherapy as usual. And some people had chemotherapy and rituximab.

Results
A total of 362 children joined this trial. The research team were able to analyse the results for 328 of them. 

They were put into 1 of 2 treatment groups at random:

  • 164 had chemotherapy 
  • 164 had chemotherapy and rituximab 

The research team looked at how many people’s lymphoma had not gone away or had come back again, about 3 years after treatment. They found it was:

  • 23 people (14%) who had chemotherapy
  • 3 people (2%) who had chemotherapy and rituximab

 

They also looked at how many people were living, and found it was:

  • 144 people (88%) who had chemotherapy
  • 156 people (95%) who had chemotherapy and rituximab

 


Side effects
Most people who took part had at least 1 side effect. Some of them were mild or didn’t last long. But some people in each group had side effects that were more serious:

  • more than 3 out of 10 people (33%) who had chemotherapy
  • nearly 4 out of 10 people (38%) who had chemotherapy and rituximab

The most common more serious side effects were:

  • a high temperature and low white blood cells (febrile neutropenia)
  • an infection
  • a sore mouth (mucositis)

Some people in each group had low levels of a protein called immunoglobulin G (IgG). Immunoglobulin G is part of our immune system. It helps us fight bacteria and viruses. 

The trial team looked at how many people had low IgG levels a year after treatment. It was:

  • more than 2 out of 10 people (25%) who had chemotherapy
  • more than 5 out of 10 people (56%) who had chemotherapy and rituximab

Conclusion
The research team concluded that rituximab and chemotherapy helped children with B cell lymphoma live longer. But it did cause more side effects. 

They suggest that children and teenagers who have B cell lymphoma should have this combination of treatment.

They also found a way for research teams around the world to work together and run trials for children with rare cancers.

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

Dr Amos Burke

Supported by

Alex Hulme Foundation
Bloodwise
Cancer Research UK
Institute Gustave-Roussy
Roche 
Syneos Health (formerly InVentiv Health)
University of Birmingham

Other information

This is Cancer Research UK trial number CRUK/11/038.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

8275

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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