E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To assess the immune response to an influenza vaccine in subjects with B-cell malignancies treated with idelalisib |
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E.1.1.1 | Medical condition in easily understood language |
To evaluate how the body's defense system against infection responds to the flu vaccine in cancer patients being treated with idelalisib |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10065856 |
E.1.2 | Term | Non-Hodgkin's lymphoma unspecified histology indolent |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
The primary objective of this study is to assess the immune response to an influenza vaccine in subjects with B-cell malignancies who are being treated with idelalisib |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) ≥ 18 years of age;
2) Currently enrolled in a Gilead-sponsored study, receiving or scheduled to initiate treatment with idelalisib for at least 7 consecutive days prior to receiving an influenza vaccine;
3) Will be receiving an influenza vaccine per standard of care;
4) Willing to comply with scheduled visits, laboratory tests, other study procedures, and study restrictions;
5) Signed informed consent form, indicating that the subject has been informed of the procedures to be followed, potential risks and discomforts, and other pertinent aspects of study participation. |
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E.4 | Principal exclusion criteria |
1) Administration of systemic steroids for more than 2 consecutive weeks within the past 3 months (i.e., 12 weeks) prior to receiving an influenza vaccination. Up to 3 single doses of systemic corticosteroids (e.g., given as a premedication) are permitted within 30 days prior to receiving an influenza vaccine, however none of these doses may be administered within 7 days prior to vaccination. Topical and inhaled steroids are permitted.
2) Intravenous immunoglobulin (IVIG) therapy within the past 3 months (i.e., 12 weeks) prior to receiving an influenza vaccination, and/or planned administration during the study period.
3) Cytotoxic chemotherapy and chronic administration (more than 14 days) of immunosuppressants within 30 days of vaccination.
4) Vaccination against influenza within the last 24 weeks prior to vaccination in this study, and/or planned administration of a second dose of influenza vaccine during the study period.
5) Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination.
6) History of severe allergic or hypersensitivity reaction that is likely to be exacerbated by any component of an influenza vaccine including egg and chicken protein, or history of hypersensitivity to a previous dose of an influenza vaccine.
7) Acute disease and/or fever at the time of baseline blood draw (fever is defined as temperature
≥ 38°C in an oral setting).
8) Presence of any condition that could, in the opinion of the investigator, compromise the subject’s ability to participate in the study, such as history of substance abuse or psychiatric condition.
9) Females who are pregnant or lactating (refer to the Gilead-sponsored parent study’s definition of ‘child-bearing potential’ to determine if pregnancy testing is required. If a pregnancy test has been performed in the Gilead-sponsored parent study ≤ 6 weeks prior to the baseline blood draw, it may be used for eligibility purposes. If a pregnancy test has not been performed in > 6 weeks, a urine pregnancy test should be performed locally). |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Seroconversion rate: Proportion of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination HI titer ≥1:40, or a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in post-vaccination HI titer
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Seroconversion rate: at 28 days [± 7 days] post-vaccination |
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E.5.2 | Secondary end point(s) |
- Seroprotection rate: Proportion of subjects with HI titer ≥1:40 post-vaccination
- GMTs of antibodies: pre- and post-vaccination GMTs of HI antibodies evaluated prior to and after vaccination
-Safety: includes AEs deemed to be related to protocol-associated procedures |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
-Seroprotection rate: at 28 days [± 7 days] post-vaccination
- GMTs of antibodies: evaluated prior to and 28 days (± 7 days) after vaccination |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
The aim of this study is to determine whether influenza vaccination is effective in eliciting a protective immune response in patients with B-cell malignancies receiving idelalisib. |
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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 | No |
E.8.1.1 | Randomised | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 | No |
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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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 | |
E.8.9.2 | In all countries concerned by the trial years | 2 |