E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Early stage (Binet stage A) Patients with chronic lymphocytic leukaemia and control group of age and sex matched healthy volunteers |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008968 |
E.1.2 | Term | Chronic lymphocytic leukaemia stage A(0) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008969 |
E.1.2 | Term | Chronic lymphocytic leukaemia stage A(I) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008970 |
E.1.2 | Term | Chronic lymphocytic leukaemia stage A(II) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with Chronic lymphocytic leukaemia stage A who have not been treated with corticosteroids, chemotherapy or monoclonal antibodies. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
+/- Application of imiquimod to vaccination site |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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If investigators or REC felt that the trial should be stopped prematurely due to suspected unexpected serious adverse events (SUSARs) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |