CLEAR: CLL Empirical Antibiotic Regimen (Version 1.0)

• Research type

  Research Study

• Full title

  A phase II trial of broad spectrum antibiotic therapy for early stage, non-progressive chronic lymphocytic leukaemia without adverse prognostic factors

• IRAS ID

  59948

• Contact name

  Stephen Devereux

• Sponsor organisation

  King's College Hospital NHS Foundation Trust

• Eudract number

  2010-022260-12

• ISRCTN Number

  n/a

• Research summary

  The aim 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 (“hidden” infections that produce no symptoms) are involved in the induction and maintenance of CLL. CLL is the commonest haematological malignancy in the western world. Based on epidemiological data from the US SEER study, there are approximately 2400 new cases of CLL diagnosed each year in the UK and about 900 deaths. In addition to its high prevalence, CLL is also notable because of its extreme clinical variability. When they do occur, the clinical features of CLL arise because of the accumulation of malignant B cells producing progressive immune dysfunction and tissue infiltration. Since the prevalence of CLL increases with advancing age and more than 50% of patients are older than 70, intensive and potentially curative therapies such as allogeneic bone marrow transplantation are not widely applicable. As CLL is presently incurable using all other drug or antibody based interventions, the development of non-toxic modes of treatment that prevent or delay the progression of early stage CLL is thus a highly desirable goal and is the objective of the current trial. Several lines of evidence support the theory that sustained antigenic stimulation by microbial or autoantigens (self- antigens) is involved in the pathogenesis of CLL. The antibiotic regimen administered in this study will comprise of a short (14 day) course of empirical broad spectrum antibiotics. Patients with previously untreated non-progressive early stage CLL will be eligible for this study. The study intends to recruit 71 patients over a period of 2 years from national CLL centres. It is expected that each participant will be in the study for 7 months.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  10/H0715/75

• Date of REC Opinion

  1 Feb 2011

• REC opinion

  Favourable Opinion