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CLL Empirical Antibiotic Regimen (CLEAR)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by King's College Hospital NHS Trust.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01279252
First Posted: January 19, 2011
Last Update Posted: September 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
King's College Hospital NHS Trust
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279252


Locations
United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
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
ClinicalTrials.gov Identifier: NCT01279252     History of Changes
Other Study ID Numbers: CLEAR
First Submitted: January 17, 2011
First Posted: January 19, 2011
Last Update Posted: September 2, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Anti-Bacterial Agents
Clarithromycin
Ciprofloxacin
Antibiotics, Antitubercular
Metronidazole
Lansoprazole
Dexlansoprazole
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