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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03701438
Recruitment Status : Enrolling by invitation
First Posted : October 10, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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).

Condition or disease Intervention/treatment
B-cell Malignancies Biological: Influenza Vaccine

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Study Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immune Response to Influenza Vaccine in Subjects With B-cell Malignancies Treated With Idelalisib
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Seroprotection Rate: Proportion of Participants with HI titer ≥ 1:40 Post-Vaccination [ Time Frame: 28 days [± 7 days] post-vaccination ]
  2. 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 ]
  3. 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) ]

Biospecimen Retention:   Samples With DNA
Blood Samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with B-cell malignancies currently receiving or initiating treatment with idelalisib in a Gilead-sponsored study.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701438


Locations
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Czechia
Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika
Prague 10, Czechia, 100 34
Fakultni nemocnice v Motole, Onkologicka klinika 2. LF UK a FN Motol
Prague 5, Czechia, 150 06
France
Centre Hospitalier Le Mans
Le Mans, France, 72037
Saint-Antoine Hospital Department of Hematology and Cell Therapy
Paris, France, 75012
Centre Hospitalier Universitaire de Poitiers Service d'Hematologie et Therapie Cellulaire
Poitiers, France, 86021
Centre Hospitalier Regional et Univeritaire de Tours
Tours, France, 37044
Poland
Malopolskie Centrum Medyczne
Kraków, Poland, 30-510
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
Warszawa, Poland, 02-781
Spain
Hospital del Mar (Servei d'Hematologia Clinica)
Barcelona, Spain, 08003
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Son Llatzer
Palma de Mallorca, Spain, 07198
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03701438     History of Changes
Other Study ID Numbers: GS-US-313-4100
2017-003055-30 ( EudraCT Number )
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasms
Vaccines
Idelalisib
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action