CLL Empirical Antibiotic Regimen

NCT01279252 | Completed Phase 2

• 1 other identifier: CLEAR
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Overall response rate [Complete Remission (CR) + Partial Remission (PR)]

  6 months

Secondary Outcomes (2)

• 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

Study Arms (1)

Antibiotic regimen

EXPERIMENTAL

Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole

Interventions

metronidazole, clarithromycin, ciprofloxacin and lansoprazole DRUG

Antibiotic regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, B-Cell

Interventions

Metronidazole; Clarithromycin; Ciprofloxacin; Lansoprazole

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles

Study Officials

• Stephen Devereux, PhD, FRCP, FRCPath

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: January 19, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2016
• Last Updated: January 25, 2019

Record last verified: 2015-09

Locations

GB (1)