Back to resultsCLL Empirical Antibiotic Regimen (CLEAR)
Primary Purpose
Chronic Lymphocytic Leukaemia (CLL)
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
metronidazole, clarithromycin, ciprofloxacin and lansoprazole
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukaemia (CLL)
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- King's College Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Antibiotic regimen
Arm Description
Outcomes
Primary Outcome Measures
Overall response rate [Complete Remission (CR) + Partial Remission (PR)]
Secondary Outcome Measures
Incidence of CTCAE grade 2 or above treatment related toxicity
Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR
Full Information
NCT ID
NCT01279252
First Posted
January 17, 2011
Last Updated
January 24, 2019
Sponsor
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01279252
Brief Title
CLL Empirical Antibiotic Regimen
Acronym
CLEAR
Official Title
A Phase II Trial of Broad Spectrum Antibiotic Therapy for Early Stage, Non-progressive Chronic Lymphocytic Leukaemia Without Adverse Prognostic Factors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
King's College Hospital NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukaemia (CLL)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antibiotic regimen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
metronidazole, clarithromycin, ciprofloxacin and lansoprazole
Primary Outcome Measure Information:
Title
Overall response rate [Complete Remission (CR) + Partial Remission (PR)]
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of CTCAE grade 2 or above treatment related toxicity
Time Frame
From day 1 to 6 weeks
Title
Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Devereux, PhD, FRCP, FRCPath
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
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CLL Empirical Antibiotic Regimen
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