A multitude of novel agents exist within the industry pipeline that may potentially be of benefit in treating paediatric mature B-cell malignancies. Whilst many agents have shown promising results in adult settings, none have been sufficiently assessed in children for them to be incorporated into standard paediatric relapse strategies.
In contrast to the plethora of potentially beneficial new agents, there are comparatively few children available to participate in clinical trials for the treatment of relapsed/refractory B-NHL. The international incidence of relapsed/refractory paediatric B-NHL is around 50-70 children per year. Therefore, the 2nd Paediatric Strategy Forum of the international multi-stakeholder platform ACCELERATE concluded that an international approach to conducting clinical trials and a robust prioritisation of novel agents to ensure only those showing the maximum potential are taken forward for investigation in paediatrics were critical in this rare cancer.
Glo-BNHL is a prospective early phase international multicentre platform clinical trial, developed as a partnership between Innovative Therapies for Children with Cancer (ITCC) and European Intergroup for Childhood NHL (EICNHL) in Europe; Children’s Oncology Group (COG) and C17 in North America; and the Australia and New Zealand Children’s Haematology and Oncology Group (ANZCHOG). The trial will evaluate the safety and efficacy of priority novel agents, alone or in combination with existing therapies, for the treatment of children, adolescents and young adults with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL).
The platform regularly seeks advice from regulatory agencies to ensure the platform generates data that can be used for medical licencing purposes, if a novel agent is successful, and has received a letter of support from the European Medicines Agency (downloadable below).