Chronic Lymphocytic Leukaemia (CLL)Phase 2CLEARNCT01279252
CLL Empirical Antibiotic Regimen
A Phase 2 study testing metronidazole, clarithromycin, ciprofloxacin and lansoprazole in people with Chronic Lymphocytic Leukaemia (CLL), run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate whether patients with previously untreated, early stage CLL respond to empirical broad spectrum antibiotics and therefore test the hypothesis that occult bacterial infections are involved in the induction and maintenance of CLL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukaemia (CLL)
- What is being tested?
- metronidazole, clarithromycin, ciprofloxacin and lansoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- ECOG performance status of 2 or less.
- CLL with a diagnostic score of 4 or 5.
- Clinical stage A disease.
- No disease progression over a minimum of 1 month prior to commencement of therapy.
- Less than 2 adverse prognostic factors.
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- Absence of adverse cytogenetics.
- Expected survival > 6 months.
- Able to give informed consent.
- No clinical evidence of active infection at the time of study entry.
- No known allergy to any of the study medications.
- Renal and liver function tests within normal limits.
Who cannot join
- Disease progression during screening period.
- Known positivity for HIV types 1 or 2.
- Active infection at the time of screening.
- Pregnancy or lactation.
- Females of childbearing potential† and males not willing to practice an effective method of contraception whilst receiving the antibiotic regimen and for 4 weeks after the last dose.
- Concomitant medication likely to produce serious interaction with study drugs including warfarin type oral anticoagulants and anti-epileptics.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SE5 9RS
About this study
Official title: A Phase II Trial of Broad Spectrum Antibiotic Therapy for Early Stage, Non-progressive Chronic Lymphocytic Leukaemia Without Adverse Prognostic Factors
The purpose of this study is to evaluate whether patients with previously untreated, early stage CLL respond to empirical broad spectrum antibiotics and therefore test the hypothesis that occult bacterial infections are involved in the induction and maintenance of CLL.
- Conditions
- Chronic Lymphocytic Leukaemia (CLL)
- Being tested
- metronidazole, clarithromycin, ciprofloxacin and lansoprazole
- Medical subject headings
- Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metronidazole, clarithromycin, ciprofloxacin and lansoprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic regimen | Experimental | Not described Receives: Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate [Complete Remission (CR) + Partial Remission (PR)]
Measured: 6 months
Secondary outcomes (2)
Incidence of CTCAE grade 2 or above treatment related toxicity
Measured: From day 1 to 6 weeks
Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukaemia (CLL)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Stephen Devereux, PhD, FRCP, FRCPath, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279252
- Sponsor's protocol ID
- CLEAR
- Acronym
- CLEAR
- Status last verified
- Sep 2015
- First submitted
- 17 Jan 2011
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Broad Spectrum Antibiotic Therapy for Early Stage, Non-progressive Chronic Lymphocytic Leukaemia Without Adverse Prognostic Factors
- ClinicalTrials.gov ID
- NCT01279252
- Acronym / sponsor ID
- CLEAR / CLEAR
- Conditions
- Chronic Lymphocytic Leukaemia (CLL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Jan 2011 (estimated)
- 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.
The purpose of this study is to evaluate whether patients with previously untreated, early stage CLL respond to empirical broad spectrum antibiotics and therefore test the hypothesis that occult bacterial infections are involved in the induction and maintenance of CLL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antibiotic regimen | Experimental | Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age > 18
- ECOG performance status of 2 or less.
- CLL with a diagnostic score of 4 or 5.
- Clinical stage A disease.
- No disease progression over a minimum of 1 month prior to commencement of therapy.
Key exclusion criteria (6 listed)
- Disease progression during screening period.
- Known positivity for HIV types 1 or 2.
- Active infection at the time of screening.
- Pregnancy or lactation.
- Females of childbearing potential† and males not willing to practice an effective method of contraception whilst receiving the antibiotic regimen and for 4 weeks after the last dose.
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 |
|---|---|---|
| metronidazole, clarithromycin, ciprofloxacin and lansoprazole | Drug | Antibiotic regimen |
Primary outcome
Overall response rate [Complete Remission (CR) + Partial Remission (PR)]
Time frame: 6 months
2 secondary outcomes
Incidence of CTCAE grade 2 or above treatment related toxicity
Time frame: From day 1 to 6 weeks
Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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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.
Stephen Devereux, PhD, FRCP, FRCPath principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing metronidazole, clarithromycin, ciprofloxacin and lansoprazole in people with Chronic Lymphocytic Leukaemia (CLL), run by King's College Hospital NHS Trust at 1 site 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 12 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall response rate [Complete Remission (CR) + Partial Remission (PR)] (time frame: 6 months). 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 25 Jan 2019.