CLL Empirical Antibiotic Regimen (CLEAR)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Lymphocytic Leukaemia (CLL)
• Intervention / Treatment: Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole

• Study Type: Interventional
• Enrollment (Anticipated): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antibiotic regimen	Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rate [Complete Remission (CR) + Partial Remission (PR)]	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of CTCAE grade 2 or above treatment related toxicity	From day 1 to 6 weeks
Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR	6 months

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Stephen Devereux, PhD, FRCP, FRCPath, King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 17, 2011
• First Submitted That Met QC Criteria: January 17, 2011
• First Posted (Estimate): January 19, 2011

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Metronidazole; Dexlansoprazole; Lansoprazole; Ciprofloxacin; Clarithromycin
• Other Study ID Numbers: CLEAR