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CLL Empirical Antibiotic Regimen (CLEAR)

This study is currently recruiting participants.
Verified July 2011 by King's College Hospital NHS Trust
Sponsor:
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01279252
First received: January 17, 2011
Last updated: August 16, 2011
Last verified: July 2011
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of CTCAE grade 2 or above treatment related toxicity [ Time Frame: From day 1 to 6 weeks ] [ Designated as safety issue: Yes ]
  • Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 71
Study Start Date: July 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antibiotic regimen Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279252

Locations
United Kingdom
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Contact: Stephen Devereux, PhD, FRCP, FRCPath     020 3299 9000 ext 3880     stephen.devereux@kcl.ac.uk    
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

No publications provided

Responsible Party: Dr Stephen Devereux, King's College Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01279252     History of Changes
Other Study ID Numbers: CLEAR
Study First Received: January 17, 2011
Last Updated: August 16, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anti-Bacterial Agents
Clarithromycin
Ciprofloxacin
Lansoprazole
 Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013