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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01279252

Acronym

CLEAR

Enrollment

Registered

2011-01-19

Start date

2011-07-31

Completion date

2016-03-31

Last updated

2019-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukaemia (CLL)

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.

Interventions

DRUGmetronidazole, clarithromycin, ciprofloxacin and lansoprazole

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026