Inter-B-NHL Ritux 2010: a phase 3 trial to find out if adding rituximab to chemotherapy improves outcomes for people under 18 with advanced-stage B-cell non-Hodgkin lymphoma or B-cell leukaemia

This trial is now closed. It is not recruiting new participants. 

Results were published part-way through the trial. Read our news update for more information.


Purpose of trial

Note: this is a trial in children and young people under 18 and the information here is aimed at parents and carers. However, you may also find this information useful if you are a young person with lymphoma or you may wish to share this information with your child if you are a parent or carer.

Lymphoma can develop from a B lymphocyte (B cell) or a T lymphocyte (T cell) . Rituximab targets a protein on B cells and is widely used for B-cell lymphomas in adults. It is not yet approved for use in people under 18. Most children and young people with B-cell lymphomas or leukaemia can be successfully treated with chemotherapy, but researchers want to find out if adding rituximab to chemotherapy could improve outcomes for those with advanced stage disease.

There are 2 parts to this trial: Part 1 needs around 40 children and young people with primary mediastinal large B-cell lymphoma. Part 2 needs around 600 children and young people with a B-cell lymphoma, like Burkitt lymphoma or diffuse large B-cell lymphoma, or Burkitt type acute lymphoblastic leukaemia.


Treatments

In Part 1, all children and young people with primary mediastinal large B-cell lymphoma receive rituximab together with the chemotherapy drugs cyclophosphamide, vincristine, prednisolone, doxorubicin and etoposide. The drugs are given in 3-weekly cycles with treatment on some days and a rest period to allow time to recover. Participants have up to 6 cycles of treatment. This part of the trial is not open to new participants as enough children and young people have already been recruited.

In Part 2, children and young people with other types of B-cell lymphoma or leukaemia who entered the trial initially were randomised to decide whether or not they receive rituximab alongside their chemotherapy. However, data from these people were analysed part-way through the trial and the results show that rituximab improves outcomes. All new participants now receive rituximab and chemotherapy. Read our news update for more information.

The chemotherapy your child has depends on the type of lymphoma or leukaemia they have. Your doctor will give you more information about the chemotherapy plan for your child. Most of the drugs are given intravenously (by injection into a vein).

Your child has 6 treatments of rituximab during their chemotherapy. Rituximab is given intravenously.


Who can enter

Your consultant can give you advice on whether this trial might be suitable for you.

Around 640 people are needed for this trial.

You may be able to enter if:

  • They have a B-cell cancer like Burkitt lymphoma, Burkitt-type acute lymphoblastic leukaemia or diffuse large B-cell lymphoma, confirmedwith a biopsy.
  • They have advanced-stage lymphoma: any stage 4 disease or stage 3 together with high levels of a chemical known as ‘LDH’ in their blood.
  • (If sexually active) They and their partner use reliable contraception during treatment and for up to 12 months after treatment if they are female and up to 5 months after treatment if they are male.
  • They are at least 6 months old but less than 18 years old.

You will not be able to enter if:


Further information

More information about this trial is available at clinicaltrials.gov.