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Completed

NCT Number: NCT01279252

CLL Empirical Antibiotic Regimen

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.

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Key information

Conditions

Chronic Lymphocytic Leukaemia (CLL) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metronidazole, clarithromycin, ciprofloxacin and lansoprazole

Drug

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Incidence of CTCAE grade 2 or above treatment related toxicity

    Time frame: From day 1 to 6 weeks

  2. Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

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

Acronym: CLEAR

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jan 19, 2011
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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