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

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 

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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

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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

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• 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 ) 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.