CLL Empirical Antibiotic Regimen

Chronic Lymphocytic Leukaemia (CLL) Clinical Trial

— CLEAR  

Official title:

A Phase II Trial of Broad Spectrum Antibiotic Therapy for Early Stage, Non-progressive Chronic Lymphocytic Leukaemia Without Adverse Prognostic Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279252
• Other study ID #: CLEAR
• Status: Completed
• Phase: Phase 2
• Start date: July 2011
• Est. completion date: March 2016

Study information

• Verified date: September 2015
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukaemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• metronidazole, clarithromycin, ciprofloxacin and lansoprazole

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate [Complete Remission (CR) + Partial Remission (PR)]		6 months
Secondary	Incidence of CTCAE grade 2 or above treatment related toxicity		From day 1 to 6 weeks
Secondary	Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR		6 months