Inclusion criteria, exclusion criteria and study summary
Acute Lymphoblastic Leukaemia (ALL) is the commonest cancer of children and young adults with over 400 cases diagnosed each year in the UK. While over 90% of children with ALL are cured, some people’s disease is harder to treat than others. ALLTogether1 investigates whether treatment can be reduced for children with the highest chance of cure, and whether the addition of new drugs improves the chance of cure for those whose disease is most likely to relapse. In the UK, ALLTogether1 will be open to patients aged 1-29 with newly-diagnosed ALL. Initially, patients will have standard chemotherapy and be registered for data collection only. Based on routine tests carried out before and during the early stages of chemotherapy, patients will be put into one of four risk groups based on how likely their disease is to relapse, for whom standard treatment and the questions that we want to ask will differ. There will also be further research questions for patients with specific needs, such as those whose leukaemia has genetic changes that can be targeted with particular drugs and patients with down syndrome. Children with standard risk and intermediate risk-low disease can take part in randomisations about whether one or two drugs can safely be removed from their standard treatment. Patients with intermediate risk-high disease can take part in a randomisation about whether adding Inotuzumab Ozogamicin to treatment can safely improve their chance of cure. We will be collaborating with researchers undertaking CAR-T cell trials and will aim to signpost young people with high risk disease to such studies. The trial will recruit approximately 8000 children and young people across Europe over a six-year period. Each patient will be on trial for at least 5 years (2 years of treatment, then a minimum of 3 years follow-up).
