Early stage (Binet stage A) Patients with chronic lymphocytic leukaemia and control group of age and sex matched healthy volunteers MedDRA version: 9.1 Level: LLT Classification code 10008968 Term: Chronic lymphocytic leukaemia stage A(0) MedDRA version: 9.1 Level: LLT Classification code 10008969 Term: Chronic lymphocytic leukaemia stage A(I) MedDRA version: 9.1 Level: LLT Classification code 10008970 Term: Chronic lymphocytic leukaemia stage A(II)
Conditions
Interventions
Trade Name: Aldara 5 % cream (imiquimod cream)
Product Name: Aldara 5 % cream
Pharmaceutical Form: Cream
Sponsors
Royal Bournemouth Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with Chronic lymphocytic leukaemia stage A who have not been treated with corticosteroids, chemotherapy or monoclonal antibodies. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients with other malignancies 2.Patients receiving corticosteroids or other immunosuppressive drugs 3.Patients who have received vaccination against influenza in the past 6 months 4.Patients who have had an allergic reaction to a flu shot in the past, or have an allergy to eggs or who previously developed Guillain-Barré syndrome within 6 weeks of getting a flu shot 5.Patients failing to give informed consent. 6.Patients using homeopathic remedies such as echniaea cream.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To correlate any differences in immune response to prognostic factors in CLL (Immunoglobulin VH gene mutation status, CD38, ZAP_70, del 11q and del 17p) and to novel immune regulatory factors.;Main Objective: 1. To determine the antibody response rates to subcutaneous vaccination with influenza vaccine (current world health organization recommended trivalent influenza vaccine for Northern hemisphere) in patients with untreated stage A chronic lymphocytic leukaemia (CLL). 2. To determine whether subsequent application of Imiquimod cream to the vaccination site will enhance the antibody and T-cell responses to influenza vaccination in a cohort of CLL patients. 3. To determine the antibody response rates to subcutaneous vaccination with influenza vaccine in a control group of age and sex matched subjects.;Primary end point(s): 1.To determine the antibody response rates to subcutaneous vaccination with influenza vaccine in patients with untreated stage A chronic lymphocytic leukaemia compared to age matched healthy controls. 2. To determine whether subsequent application of Imiquimod cream to the vaccination site will enhance the antibody and T-cell response. | — |
Countries
United Kingdom
Outcome results
None listed