B-cell MalignanciesNCT03701438
Immune Response to Influenza Vaccine in Adults With B-cell Malignancies Treated With Idelalisib
An observational study of B-cell Malignancies, run by Gilead Sciences at 2 sites in 2 countries.
Trial summary
The primary objective of this study is to assess the immune response to an influenza vaccine in adults with B-cell malignancies who are currently receiving treatment with idelalisib in a Gilead-sponsored study (parent study). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Malignancies
- What is being tested?
- Influenza Vaccine
- Type of treatment
- Vaccines
- How many people
- 2 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Oct 2018to 9 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with B-cell malignancies currently receiving or initiating treatment with idelalisib in a Gilead-sponsored study.
Who may be able to join
- 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
- Will be receiving an influenza vaccine per standard of care
- Willing to comply with scheduled visits, laboratory tests, other study procedures, and study restrictions
- 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
Who cannot join
- 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 influenza vaccination. Topical and inhaled steroids are permitted
- 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
- Cytotoxic chemotherapy and chronic administration (more than 14 days) of immunosuppressants within 30 days of vaccination
- 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.
- 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
- 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
Show all 10Show fewer
- Acute disease and/or fever at the time of baseline blood draw (fever is defined as temperature ≥ 38°C in an oral setting)
- 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
- 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.
- Note: Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Czechia1 site
Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika
Prague, 100 34
About this study
Official title: Immune Response to Influenza Vaccine in Subjects With B-cell Malignancies Treated With Idelalisib
The primary objective of this study is to assess the immune response to an influenza vaccine in adults with B-cell malignancies who are currently receiving treatment with idelalisib in a Gilead-sponsored study (parent study).
- Conditions
- B-cell Malignancies
- Being tested
- Influenza Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccineBiological
Administered per standard of care using a vaccine licensed and recommended in the site's country
| Study group | Role | What they receive |
|---|---|---|
| Idelalisib | Participants currently enrolled in a Gilead-sponsored study, who are currently being treated with 100 or 150 mg of idelalisib twice daily for at least 7 consecutive days prior to receiving an influenza vaccine. Receives: Biological: Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion Rate: Proportion of Participants with Either a Pre-Vaccination Hemagglutination Inhibition (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
Measured: 28 days [± 7 days] post-vaccination
Secondary outcomes (3)
Seroprotection Rate: Proportion of Participants with HI titer ≥ 1:40 Post-Vaccination
Measured: 28 days [± 7 days] post-vaccination
Geometric Mean Titers (GMTs) of Antibodies: Pre- and Post-Vaccination GMTs of HI Antibodies Evaluated Prior to and 28 days (± 7 Days) After Vaccination
Measured: Prior to and 28 days (± 7 days) after vaccination
Percentage of Participants with Adverse Events or Serious Adverse Events From Time of Baseline Blood Draw Until Day 28 (Post Vaccination) Visit
Measured: Baseline Blood Draw; Day 28 (± 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start23 Oct 2018
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Why it stopped: The Swissmedic agency released Gilead from this post marketing requirement.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell MalignanciesStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701438
- Sponsor's protocol ID
- GS-US-313-4100
- Other IDs
- 2017-003055-30, 2017
- Status last verified
- Nov 2019
- First submitted
- 8 Oct 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Influenza Vaccine in Subjects With B-cell Malignancies Treated With Idelalisib
- ClinicalTrials.gov ID
- NCT03701438
- Acronym / sponsor ID
- GS-US-313-4100
- Conditions
- B-cell Malignancies
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Swissmedic agency released Gilead from this post marketing requirement.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 10 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the immune response to an influenza vaccine in adults with B-cell malignancies who are currently receiving treatment with idelalisib in a Gilead-sponsored study (parent study).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idelalisib | – | Biological: Influenza VaccineParticipants currently enrolled in a Gilead-sponsored study, who are currently being treated with 100 or 150 mg of idelalisib twice daily for at least 7 consecutive days prior to receiving an influenza vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with B-cell malignancies currently receiving or initiating treatment with idelalisib in a Gilead-sponsored study.
Key inclusion criteria (4 listed)
- 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
- Will be receiving an influenza vaccine per standard of care
- Willing to comply with scheduled visits, laboratory tests, other study procedures, and study restrictions
- 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
Key exclusion criteria (10 listed)
- 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 influenza vaccination. Topical and inhaled steroids are permitted
- 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
- Cytotoxic chemotherapy and chronic administration (more than 14 days) of immunosuppressants within 30 days of vaccination
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza VaccineAdministered per standard of care using a vaccine licensed and recommended in the site's country | Biological | Idelalisib |
Primary outcome
Seroconversion Rate: Proportion of Participants with Either a Pre-Vaccination Hemagglutination Inhibition (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
Time frame: 28 days [± 7 days] post-vaccination
3 secondary outcomes
Seroprotection Rate: Proportion of Participants with HI titer ≥ 1:40 Post-Vaccination
Time frame: 28 days [± 7 days] post-vaccination
Geometric Mean Titers (GMTs) of Antibodies: Pre- and Post-Vaccination GMTs of HI Antibodies Evaluated Prior to and 28 days (± 7 Days) After Vaccination
Time frame: Prior to and 28 days (± 7 days) after vaccination
Percentage of Participants with Adverse Events or Serious Adverse Events From Time of Baseline Blood Draw Until Day 28 (Post Vaccination) Visit
Time frame: Baseline Blood Draw; Day 28 (± 7 days)
Results and safety
The study was stopped early (reason given: The Swissmedic agency released Gilead from this post marketing requirement.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-cell Malignancies, run by Gilead Sciences at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The Swissmedic agency released Gilead from this post marketing requirement.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion Rate: Proportion of Participants with Either a Pre-Vaccination Hemagglutination Inhibition (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 (time frame: 28 days [± 7 days] post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.