An interim analysis part-way through a phase 3 trial testing the safety and effectiveness of adding rituximab to chemotherapy for under-18s with advanced-stage (widespread) B-cell NHL and acute leukaemia has shown practice-changing results.
Rituximab is an antibody therapy that targets a protein on B-cells and is widely used for B-cell lymphomas in adults. The Inter-B-NHL Ritux 2010 trial was designed to test whether rituximab could also benefit children and adolescents with advanced-stage, aggressive (fast-growing) B-cell blood cancers.
Around 600 under-18s with a B-cell lymphoma like Burkitt lymphoma or diffuse large B-cell lymphoma or Burkitt type acute lymphoblastic leukaemia are needed for the trial. A total of 310 people had been randomised at the time of the interim analysis; half received chemotherapy and the other half received chemotherapy and rituximab. Most of the people recruited (more than 8 in 10; 85%) had Burkitt lymphoma.
After 1 year:
- More than 9 in 10 (94.2%) of people who had rituximab were still in remission, compared with around 8 in 10 (81.5%) of those who didn’t receive rituximab.
- Only 1 person who had rituximab relapsed, compared with 12 people who didn’t have rituximab.
- There was little difference in side effects between the groups, although more people in the rituximab group had febrile neutropenia (infection associated with low white blood cells).
Because of the very high probability that the final results will confirm the benefit of rituximab, new participants in this trial are not being randomised. Everyone entering the trial will have rituximab with chemotherapy.
Results of the interim analysis were presented at the 2016 ASCO (American Society of Clinical Oncology) meeting in June 2016. The abstract is available at http://meetinglibrary.asco.org/content/164975-176.