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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
January 17, 2011
January 19, 2011
September 2, 2015
July 2011
January 2015   (Final data collection date for primary outcome measure)
Overall response rate [Complete Remission (CR) + Partial Remission (PR)] [ Time Frame: 6 months ]
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 ]
  • Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR [ Time Frame: 6 months ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Unknown status
71
December 2015
January 2015   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01279252
CLEAR
No
Not Provided
Not Provided
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
September 2015

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