CLL Empirical Antibiotic Regimen

NCT ID: NCT01279252

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukaemia (CLL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antibiotic regimen

Group Type: EXPERIMENTAL

metronidazole, clarithromycin, ciprofloxacin and lansoprazole

Intervention Type: DRUG

Interventions

metronidazole, clarithromycin, ciprofloxacin and lansoprazole

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College Hospital NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

King's College Hospital NHS Foundation Trust

Principal Investigators

Stephen Devereux, PhD, FRCP, FRCPath

Role: PRINCIPAL_INVESTIGATOR

King's College Hospital NHS Trust

Locations

King's College Hospital NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

CLEAR

Identifier Type: -

Identifier Source: org_study_id