A randomized phase II trial to determine whether the application of imiquimod cream to the vaccination site can improve the immune responsiveness to influenza vaccination in patients with untreated stage A CLL. - CLLIFVAC
- Conditions
- Early stage (Binet stage A) Patients with chronic lymphocytic leukaemia and control group of age and sex matched healthy volunteersMedDRA version: 9.1Level: LLTClassification code 10008968Term: Chronic lymphocytic leukaemia stage A(0)MedDRA version: 9.1Level: LLTClassification code 10008969Term: Chronic lymphocytic leukaemia stage A(I)MedDRA version: 9.1Level: LLTClassification code 10008970Term: Chronic lymphocytic leukaemia stage A(II)
- Registration Number
- EUCTR2006-004902-16-GB
- Lead Sponsor
- Royal Bournemouth Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 102
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method