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CLL Empirical Antibiotic Regimen (CLEAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by King's College Hospital NHS Trust.
Recruitment status was  Recruiting
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

January 17, 2011
August 16, 2011
July 2011
October 2013   (final data collection date for primary outcome measure)
Overall response rate [Complete Remission (CR) + Partial Remission (PR)] [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01279252 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
CLL Empirical Antibiotic Regimen
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukaemia (CLL)
Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole
Experimental: Antibiotic regimen
Intervention: Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
71
October 2013
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
United Kingdom
 
NCT01279252
CLEAR
No
Dr Stephen Devereux, King's College Hospital NHS Foundation Trust
King's College Hospital NHS Trust
Not Provided
Principal Investigator: Stephen Devereux, PhD, FRCP, FRCPath King's College Hospital NHS Trust
King's College Hospital NHS Trust
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP