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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukaemia (CLL)

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Stephen Devereux, PhD, FRCP, FRCPath

Investigator Role:

Principal Investigator

Investigator Affiliation:

King's College Hospital NHS Trust

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CLEAR

NCT ID:

NCT01279252

Start Date:

July 2011

Completion Date:

October 2013

Related Keywords:

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

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