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CLL Empirical Antibiotic Regimen (CLEAR)

This study is ongoing, but not recruiting participants.
Information provided by:
King's College Hospital NHS Trust Identifier:
First received: January 17, 2011
Last updated: September 1, 2015
Last verified: September 2015
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.

Condition Intervention Phase
Chronic Lymphocytic Leukaemia (CLL) Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Broad Spectrum Antibiotic Therapy for Early Stage, Non-progressive Chronic Lymphocytic Leukaemia Without Adverse Prognostic Factors

Resource links provided by NLM:

Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • Overall response rate [Complete Remission (CR) + Partial Remission (PR)] [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 71
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antibiotic regimen Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01279252

United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
Principal Investigator: Stephen Devereux, PhD, FRCP, FRCPath King's College Hospital NHS Trust
  More Information

Responsible Party: Dr Stephen Devereux, King's College Hospital NHS Foundation Trust Identifier: NCT01279252     History of Changes
Other Study ID Numbers: CLEAR
Study First Received: January 17, 2011
Last Updated: September 1, 2015

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors processed this record on August 22, 2017