Immune Response to Influenza Vaccine in Adults With B-cell Malignancies Treated With Idelalisib

February 18, 2020 updated by: Gilead Sciences

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague 10, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika
  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with B-cell malignancies currently receiving or initiating treatment with idelalisib in a Gilead-sponsored study.

Description

Key Inclusion Criteria:

  • 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:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: Influenza Vaccine
Administered per standard of care using a vaccine licensed and recommended in the site's country

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
28 days [± 7 days] post-vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Seroprotection Rate: Proportion of Participants with HI titer ≥ 1:40 Post-Vaccination
Time Frame: 28 days [± 7 days] post-vaccination
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
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)
Baseline Blood Draw; Day 28 (± 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-313-4100
  • 2017-003055-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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