Acute Lymphoblastic Leukaemia - CategoryCiproPALNCT04678869
CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)
A study testing Ciprofloxacin and Antibiotic in people with Acute Lymphoblastic Leukaemia - Category, run by University College, London at 14 sites in United Kingdom.
Trial summary
CiproPAL is a randomised trial comparing daily ciprofloxacin with local standard care during the induction phase of paediatric ALL treatment, and aims: 1. To assess the efficacy of ciprofloxacin prophylaxis in the reduction of infection during the induction phase of treatment for paediatric Acute Lymphoblastic… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukaemia - Category
- What is being tested?
- Ciprofloxacin and Antibiotic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- 29 Jun 2022to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Paediatric patients (1-17 years inclusive) with de-novo Acute Lymphoblastic Leukaemia treated on ALLTogether-1 in the UK in the first 5 days of therapy, up to 14 days is acceptable.
- Written informed consent
Who cannot join
- Non-participants of the ALLTogether-1 trial
- Patients with Down syndrome who already receive ciprofloxacin prophylaxis
- Chronic active arthritis
- Other contraindication to fluoroquinolones
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
Royal Aberdeen Children's Hospital
Aberdeen
Bristol Royal Hospital for Children
Bristol
Addenbrookes Hospital
Cambridge
Leeds General Infirmary
Leeds
Leicester Royal Infirmary
Leicester
Alder Hey Children's Hospital
Liverpool
Great Ormond Street Hospital
London
Univeristy College Hospital London
London
Royal Manchester Children's Hospital
Manchester
Royal Victoria Infirmary
Newcastle
Nottingham Children's Hospital
Nottingham
John Radcliffe Hospital
Oxford
Sheffield Children's Hospital
Sheffield
Southampton General Hospital
Southampton
About this study
Official title: 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 ALLTogether-1 Treatment Protocol
CiproPAL is a randomised trial comparing daily ciprofloxacin with local standard care during the induction phase of paediatric ALL treatment, and aims:
- To assess the efficacy of ciprofloxacin prophylaxis in the reduction of infection during the induction phase of treatment for paediatric Acute Lymphoblastic Leukaemia within the ALLTogether-1 Trial.
- To evaluate the impact of ciprofloxacin prophylaxis on antimicrobial resistance, both of invasive infections and colonising organisms.
Read the detailed description
This is a multi-centre randomised trial of prophylactic ciprofloxacin (10mg/kg BD, enteral/IV) versus standard of care during the neutropenic period of induction (with an internal pilot study) in patients aged 1-17 years with de-novo ALL treated on ALLTogether-1. Exclusion criteria include: patients with Down syndrome (who already receive ciprofloxacin prophylaxis), contraindication to fluoroquinolones, non-consent to ALLTogether-1 or CiproPAL. AMR of colonising organisms will be assessed with stool or peri-rectal swab cultures performed at five timepoints within the first year. Longer term invasive infection AMR monitoring will include sensitivity testing of all organisms isolated in confirmed infection for the duration of ALLTogether-1.
The primary outcome is the rate of sterile site bacterial infections during induction, evaluated by intention to treat analysis. Secondary outcomes include rates of febrile episodes, febrile neutropenia, severe infection and infection-related death; rates of AMR; antibiotic exposure; secondary infections; and quinolone side effects. A model-based health economic analysis will be undertaken. Using a conservative effect estimate of 40% reduction in bacteraemia (i.e. a reduction from 15% to 9%) 1052 patients randomised 1:1 gives 85% power with a 5% 2-sided alpha.
- Conditions
- Acute Lymphoblastic Leukaemia - Category
- Being tested
- Ciprofloxacin, Antibiotic
- Keywords
- antibiotic prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)
AntibioticDrug
Standard of care antibiotic as per local policy
| Study group | Role | What they receive |
|---|---|---|
| Cirprofloxacin prophylaxis | Experimental | prophylactic ciprofloxacin (10mg/kg BD, enteral/IV) Receives: Drug: Ciprofloxacin |
| Standard of care | Active comparator | standard of care Receives: Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of sterile site bacterial infections during induction
rate of sterile site bacterial infections during induction
Measured: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
Secondary outcomes (7)
rates of febrile episodes
rates of febrile episodes
Measured: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of febrile neutropenia
rates of febrile neutropenia
Measured: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of severe infection and infection-related death
severe infection rates and deaths from infection
Measured: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of AMR (antimicrobial resistance)
rates of AMR
Measured: Until the end of trial approx 10 years (from randomisation until the end of trial declaration in 2031)
rates of antibiotic exposure
rates of antibiotic exposure
Measured: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of secondary infections
rates of secondary infections
Measured: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
quinolone side effects
quinolone side effects
Measured: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start29 Jun 2022
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukaemia - CategoryStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised trial of prophylactic ciprofloxacin (10mg/kg BD, enteral/IV) versus standard of care during the neutropenic period of induction (with an internal pilot study) in patients aged 1-17 years with de-novo ALL treated on ALLTogether-1. Exclusion
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Robert Phillips, Principal investigator, University of York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678869
- Sponsor's protocol ID
- CiproPAL (129038)
- Acronym
- CiproPAL
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2020
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for de-identified data should be made in writing to the relevant trials group lead at the CR UK and UCL Cancer Trials Centre (https://www.ctc.ucl.ac.uk/DataSampleSharing.aspx)
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ALLTogether-1 Treatment Protocol
- ClinicalTrials.gov ID
- NCT04678869
- Acronym / sponsor ID
- CiproPAL / CiproPAL (129038)
- Conditions
- Acute Lymphoblastic Leukaemia - Category
- Keywords
- antibiotic prophylaxis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 313 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CiproPAL is a randomised trial comparing daily ciprofloxacin with local standard care during the induction phase of paediatric ALL treatment, and aims:
- To assess the efficacy of ciprofloxacin prophylaxis in the reduction of infection during the induction phase of treatment for paediatric Acute Lymphoblastic Leukaemia within the ALLTogether-1 Trial.
- To evaluate the impact of ciprofloxacin prophylaxis on antimicrobial resistance, both of invasive infections and colonising organisms.
Detailed description
This is a multi-centre randomised trial of prophylactic ciprofloxacin (10mg/kg BD, enteral/IV) versus standard of care during the neutropenic period of induction (with an internal pilot study) in patients aged 1-17 years with de-novo ALL treated on ALLTogether-1. Exclusion criteria include: patients with Down syndrome (who already receive ciprofloxacin prophylaxis), contraindication to fluoroquinolones, non-consent to ALLTogether-1 or CiproPAL. AMR of colonising organisms will be assessed with stool or peri-rectal swab cultures performed at five timepoints within the first year. Longer term invasive infection AMR monitoring will include sensitivity testing of all organisms isolated in confirmed infection for the duration of ALLTogether-1.
The primary outcome is the rate of sterile site bacterial infections during induction, evaluated by intention to treat analysis. Secondary outcomes include rates of febrile episodes, febrile neutropenia, severe infection and infection-related death; rates of AMR; antibiotic exposure; secondary infections; and quinolone side effects. A model-based health economic analysis will be undertaken. Using a conservative effect estimate of 40% reduction in bacteraemia (i.e. a reduction from 15% to 9%) 1052 patients randomised 1:1 gives 85% power with a 5% 2-sided alpha.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised trial of prophylactic ciprofloxacin (10mg/kg BD, enteral/IV) versus standard of care during the neutropenic period of induction (with an internal pilot study) in patients aged 1-17 years with de-novo ALL treated on ALLTogether-1. Exclusion
| Arm | Type | Receives |
|---|---|---|
| Cirprofloxacin prophylaxis | Experimental | Drug: Ciprofloxacinprophylactic ciprofloxacin (10mg/kg BD, enteral/IV) |
| Standard of care | Active comparator | Drug: Antibioticstandard of care |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Paediatric patients (1-17 years inclusive) with de-novo Acute Lymphoblastic Leukaemia treated on ALLTogether-1 in the UK in the first 5 days of therapy, up to 14 days is acceptable.
- Written informed consent
Key exclusion criteria (4 listed)
- Non-participants of the ALLTogether-1 trial
- Patients with Down syndrome who already receive ciprofloxacin prophylaxis
- Chronic active arthritis
- Other contraindication to fluoroquinolones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofloxacinprophylactic ciprofloxacin (10mg/kg BD, enteral/IV) | Drug | Cirprofloxacin prophylaxis |
| AntibioticStandard of care antibiotic as per local policy | Drug | Standard of care |
Primary outcome
rate of sterile site bacterial infections during induction
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rate of sterile site bacterial infections during induction
7 secondary outcomes
rates of febrile episodes
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of febrile neutropenia
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of severe infection and infection-related death
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of AMR (antimicrobial resistance)
Time frame: Until the end of trial approx 10 years (from randomisation until the end of trial declaration in 2031)
rates of antibiotic exposure
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of secondary infections
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
quinolone side effects
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. Requests for de-identified data should be made in writing to the relevant trials group lead at the CR UK and UCL Cancer Trials Centre (https://www.ctc.ucl.ac.uk/DataSampleSharing.aspx)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Phillips principal investigator
University of York
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ciprofloxacin and Antibiotic in people with Acute Lymphoblastic Leukaemia - Category, run by University College, London at 14 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of sterile site bacterial infections during induction (time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.