A new nationwide trial has launched in the UK for children with acute lymphoblastic leukaemia (ALL). The CiproPAL trial (Ciprofloxacin Prophylaxis in Acute Leukaemia) serves as an add-on randomised trial to the ALLTogether1 trial (which is Sponsored by Karolinska University Hospital and coordinated in the UK by the CR UK and UCL Cancer Trials Centre). 

The trial aims to assess the effectiveness of giving a low dose of the antibiotic Ciprofloxacin in reducing infections during the first stage, referred to as the “induction stage”, of ALL treatment in children who are being treated on the ALLTogether-1 trial. It will do this by comparing the treatment arm of the study (Ciprofloxacin) with a control arm (standard of care).

It also aims to evaluate the impact of these antibiotics on antimicrobial resistance, via the collection of stool samples or peri-rectal swabs. The trial design as an add-on optimises data collection and the efficacy of research; only the additional data required for CiproPAL will be collected onto an electronic database, removing duplicate data entry and outcome collection.

CiproPAL is being funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA). The trial is being coordinated by the Cancer Research UK & UCL Cancer Trials Centre and plans to recruit 1052 patients from 20 hospitals across the UK over a period of three and a half years.

Dr Bob Phillips, chief investigator of the trial and Senior Lecturer and Honorary Consultant in Paediatric Oncology at the University of York said “As about half of the deaths in children’s leukaemia come from infection we believe a rapid increase in survival, combined with an improvement in quality of life and reduction in traumatic periods of hospitalisation, could be achieved with this trial. The first step on the 1000 mile journey has been taken!”

The current National Institute of Health and Care Excellent guidelines on neutropenic sepsis (a serious and potentially fatal reaction to an infection), state that the use of antibiotics as prophylaxis to prevent infection should be offered only to adult patients with acute leukaemia, of which there is a reported benefit. The CiproPAL trial is keen to see if this benefit will be seen in children, where the nature of the disease and its treatment are different, and currently CiproPAL is the only randomised trial addressing the issue of infection-related ALL deaths in children.  

This trial has heavily relied upon our patient and public involvement (PPI) group, which consists of parents of children with diagnosed with ALL. They highlighted the importance of reducing serious infections given the impact on patients’ health and family experiences, demonstrating a clear requirement for this trial in this area. 

Recruitment began at Leicester Royal Infirmary on 29/06/2022, with our first patient randomised on the 13/07/2022. We are looking forward to working with all of our participating sites on this important journey to reduce infection-related ALL deaths.