ALLTogether1
Research type
Research Study
Full title
ALLTogether1– A Treatment study protocol of the ALLTogether Consortium for children and young adults (0-45 years of age) with newly diagnosed acute lymphoblastic leukaemia (ALL)
IRAS ID
272164
Contact name
John Moppett
Contact email
Sponsor organisation
Karolinska University Hospital
Eudract number
2018-001795-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
years, months, days
Research 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).
REC name
London - Brent Research Ethics Committee
REC reference
20/LO/0848
Date of REC Opinion
16 Oct 2020
REC opinion
Further Information Favourable Opinion