Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
29/06/2022
Funder:
NIHR/HTA
Sponsor:
UCL
Chief Investigator:
Dr Bob Phillips
Recruitment target:
566
EudraCT number:
2021-000341-40
Contact details:
ctc.cipropal@ucl.ac.uk
Note: For enquiries only. DO NOT use for clinical referrals.
Lay summary:
CiproPAL
CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia): A randomised trial to assess the use of ciprofloxacin prophylaxis to prevent bacterial infection in children treated on the induction phase of the ALLTogether1 treatment protocol.
Description
Design: Multi-centre, randomised open-label trial.

NOTE: This trial halted to recruitment early on 23-Jan-2026.
Treatment:

Eligible patients who consent to take part in CiproPAL and who are already enrolled in ALLTogether1 will be randomised (1:1) to the interventional arm or control arm of the trial.

Patients randomised to the interventional arm will receive prophylactic ciprofloxacin (10mg/kg twice a day, enteral or intravenously) from randomisation to the end of induction. Specifically, prophylactic ciprofloxacin should commence as soon as possible after randomisation (within the first 5-8 days of induction therapy) and continue until neutrophil recovery sufficient for the commencement of consolidation (ANC >0.5x109/L).

Patients randomised to the control arm will receive no additional treatment during induction. Such patients should receive the standard of care, as per local policy.

Any febrile episodes should be treated according tolocal guidelines. For patients in the interventionalarm (receiving prophylactic ciprofloxacin),ciprofloxacin prophylaxis should be stopped for theduration of any treatment with broad spectrumantibiotics, empirically or for a defined infection, andre-started afterwards. If antibiotic coverage isrationalised to treat a specific infection, for exampleteicoplanin for a Coagulase negativeStaphylococcus central line infection, thenciprofloxacin should be restarted. If there are anyuncertainties regarding restarting ciprofloxacinplease contact UCL CTC who will enquire with thetrial management group (TMG).

Key inclusion/exclusion criteria:

Inclusion:

• Paediatric patients (1-17 years inclusive) withde-novo Acute Lymphoblastic Leukaemiatreated on ALLTogether1 in the UK in the first 5-8 days of therapy.

• Written informed consent.

Exclusion:

• Non-participants of the ALLTogether1 trial.

• Patients with Down syndrome.

• Patients with chronic active arthritis.

• Patients with any other contraindication tofluoroquinolones.

Duration of recruitment: 42 months
Aim

1. To assess the efficacy of ciprofloxacin prophylaxisin reducing infections during the induction phase ofthe ALLTogether1 Trial.

2. To evaluate the impact of ciprofloxacin prophylaxison antimicrobial resistance, both of invasiveinfections and colonising organisms.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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