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    Summary
    EudraCT Number:2017-003055-30
    Sponsor's Protocol Code Number:GS-US-313-4100
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-07-31
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-003055-30
    A.3Full title of the trial
    Immune Response to Influenza Vaccine in Subjects with B-cell Malignancies Treated with Idelalisib
    Respuesta inmunitaria a la vacuna de la gripe en pacientes con neoplasias malignas de células B tratados con idelalisib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of how body's defense system against infection responds to the flu vaccine in cancer patients being treated with idelalisib
    Evaluación de como el sistema immunitario responde a la vacuna de la gripe en pacientes con cancer tratados con Idealisib
    A.4.1Sponsor's protocol code numberGS-US-313-4100
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Zydelig 100 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIdelalisib
    D.3.2Product code IDELA, GS-1101
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIDELALISIB
    D.3.9.1CAS number 870281-82-6
    D.3.9.2Current sponsor codeGS-1101
    D.3.9.3Other descriptive nameIDELA
    D.3.9.4EV Substance CodeSUB126168
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Zydelig 150 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIdelalisib
    D.3.2Product code IDELA, GS-1101
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIDELALISIB
    D.3.9.1CAS number 870281-82-6
    D.3.9.2Current sponsor codeGS-1101
    D.3.9.3Other descriptive nameIDELA
    D.3.9.4EV Substance CodeSUB126168
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    To assess the immune response to an influenza vaccine in subjects with B-cell malignancies treated with idelalisib
    Evaluar la respuesta inmunitaria a la vacuna de la gr4ipe en pacientes con neoplasias malignas de células B tratados con idelalisib
    E.1.1.1Medical 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
    Evaluar cómo el sistema inmunitario responde a la vacuna de la gripe en pacientes con cancer tratados con Idelaisib
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10065856
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology indolent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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
    El objetivo principal de este estudio es evaluar la respuesta inmunitaria a una vacuna de la gripe en pacientes con neoplasias malignas de células B que están siendo tratados con idelalisib
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    1) >= 18 años de edad.
    2) Incluido actualmente en un estudio promovido por Gilead, está recibiendo o tiene previsto iniciar el tratamiento con idelalisib durante al menos 7 días consecutivos antes de recibir una vacuna de la gripe.
    3) Recibirá una vacuna de la gripe conforme a la práctica clínica habitual
    4) Dispuesto a cumplir con las visitas programadas, los análisis de laboratorio, otros procedimientos del estudio y las restricciones del mismo.
    5) Ha firmado el formulario de consentimiento informado, que indica que el paciente ha sido informado de los procedimientos que debe seguir, los posibles riesgos y molestias, y de otros aspectos pertinentes a la participación en el estudio.
    E.4Principal 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).
    1) Administración de esteroides sistémicos durante más de 2 semanas consecutivas en los 3 meses (es decir, 12 semanas) anteriores a recibir una vacunación contra la gripe. Se permiten hasta 3 dosis únicas de corticosteroides sistémicos (p. ej., administrados como premedicación) en los 30 días anteriores a recibir una vacuna de la gripe, sin embargo, ninguna de esas dosis podrá administrarse en los 7 días previos a la vacunación contra la gripe. Se permiten los esteroides tópicos e inhalados.
    2) Tratamiento con inmunoglobulina intravenosa (IGIV) en los 3 meses previos (es decir, 12 semanas) a recibir una vacuna de la gripe y/o tiene prevista dicha administración durante el periodo del estudio.
    3) Quimioterapia citotóxica y administración crónica (durante más de 14 días) de inmunosupresores en los 30 días antes de la vacunación.
    4) Vacunación contra la gripe en las últimas 24 semanas antes de la vacunación en este estudio, y/o tiene prevista la administración de una segunda dosis de vacuna de la gripe durante el periodo del estudio.
    5) Administración de cualquier vacuna en las 4 semanas anteriores a la vacunación del ensayo o administración programada de cualquier vacuna en las 4 semanas posteriores a la vacunación del ensayo.
    6) Antecedentes de reacción alérgica o de hipersensibilidad grave que probablemente empeore con algún componente de una vacuna de la gripe, incluida la proteína de huevo y pollo, o antecedentes de hipersensibilidad a una dosis previa de una vacuna de la gripe.
    7) Enfermedad aguda y/o fiebre en el momento de la extracción de sangre inicial (la fiebre se define como una temperatura ≥38 °C medida en la boca).
    8) Presencia de cualquier afección que pudiese, en opinión del investigador, menoscabar la capacidad del paciente para participar en el estudio, incluidos antecedentes de toxicomanía o de enfermedad psiquiátrica.
    9) Mujeres que están embarazadas o en periodo de lactancia (véase la definición de “capacidad de concebir” del estudio original promovido por Gilead para determinar si es necesaria la prueba de embarazo. Si se ha realizado una prueba de embarazo en el estudio original promovido por Gilead ≤6 semanas antes de la extracción de sangre inicial, podrá usarse con fines de selección. Si no se ha realizado una prueba de embarazo en más de 6 semanas, deberá hacerse una prueba de embarazo en orina a nivel local).
    E.5 End points
    E.5.1Primary 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
    •Tasa de seroconversión: proporción de pacientes con un título de IH previo a la vacuna <1:10 y un título de IH posterior a la vacuna >=1:40, o con un título de IH previo a la vacuna >=1:10 y un aumento >=4 veces en el título de IH posterior a la vacuna.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Seroconversion rate: at 28 days [± 7 days] post-vaccination
    • Tasa de seroconversión: a los 28 días [±7 días] después de la vacuna)
    E.5.2Secondary 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
    • Tasa de seroprotección: proporción de pacientes con un título de IH ≥1:40 después de la vacuna.
    • Títulos medios geométricos (TMG) de anticuerpos: TMG previos y posteriores a la vacuna de los anticuerpos IH evaluados antes y después de la vacuna.
    • Seguridad: acontecimientos adversos que se consideren relacionados con los procedimientos asociados al protocolo
    E.5.2.1Timepoint(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
    • Tasa de seroprotección: a los 28 días [±7 días] después de la vacuna
    • Títulos medios geométricos (TMG) de anticuerpos: evaluados antes y 28 días (±7 días) después de la vacuna.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other 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.
    El objetivo de este estudio es determinar si la vacunación contra la gripe es efectiva para provocar una respuesta inmune protectora en pacientes con neoplasias malignas de células B que reciben idelalisib
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other 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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LVLS
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 22
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After a patient has completed / terminated their study participation, long term care for the participant will remain the responsibility of their primary treating physician
    Despues de que el paciente haya completado/terminado su participacion en el estudio, los cuidados a largo plazo seran responsabilidad de su medico de atencion primaria
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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