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    Summary
    EudraCT Number:2015-000479-28
    Sponsor's Protocol Code Number:LTS13932
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-23
    Trial 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 ConcernedCzechia - SUKL
    A.2EudraCT number2015-000479-28
    A.3Full title of the trial
    A Phase II Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
    Otevřená studie fáze II hodnotící sargramostim u pacientů léčených myelosupresivní indukční chemoterapií pro akutní myeloidní leukémii
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
    A.4.1Sponsor's protocol code numberLTS13932
    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 SponsorGenzyme Corporation
    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 supportGenzyme Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenzyme Europe B.V.
    B.5.2Functional name of contact pointMedical Information Genzyme Europe
    B.5.3 Address:
    B.5.3.1Street AddressGooimeer 10
    B.5.3.2Town/ cityNaarden
    B.5.3.3Post code1411 DD
    B.5.3.4CountryNetherlands
    B.5.6E-maileumedinfo@genzyme.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 Leukine
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Corporation
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.2Product code GZ402664
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSARGRAMOSTIM
    D.3.9.1CAS number 123774-72-1
    D.3.9.2Current sponsor codeGZ402664
    D.3.9.4EV Substance CodeSUB10450MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/m2 microgram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Myeloid Leukemia NOS
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukemia NOS
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid leukaemia
    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
    Measure the proportion of patients who develop binding and neutralizing antibodies in the blood after treatment with sargramostim following induction/reinduction chemotherapy.
    E.2.2Secondary objectives of the trial
    Assess the time after treatment at which the antibodies develop and the level of
    antibodies is measured after the first dose.
    Measure the levels of immunoglobulin protein.
    Assess the impact of any immune response on safety and the duration of low
    white blood cell count.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Able to provide informed consent.
    Newly diagnosed acute myeloid leukemia (AML) to be treated with standard of care induction chemotherapy as per local policy.
    Patients 55 to 70 years of age (inclusive).
    Negative serum pregnancy test within 30 days prior to receiving the first dose of induction
    chemotherapy in female participants who are <2 years postmenopausal or who are of childbearing potential and have agreed to begin or continue using an adequate method of contraception.
    E.4Principal exclusion criteria
    Prior treatment with sargramostim or any leukocyte growth factor (LGF) product.
    Prior myelodysplastic syndrome (MDS).
    Known central nervous system (CNS) leukemic involvement diagnosed by cytologic findings in cerebrospinal fluid and/or by computed tomography (CT) or magnetic resonance imaging (MRI).
    Out of range (>2x normal) laboratory values.
    Clinically important medical conditions unrelated to AML as determined by the Investigator.
    Eastern Cooperative Oncology Group (ECOG) performance status >2.
    Bone marrow blasts ≥5% on marrow examination following induction or reinduction chemotherapy.
    History of allergy to yeast products, recombinant human granulocyte/macrophage-colony-stimulating factor, or any component of sargramostim.
    E.5 End points
    E.5.1Primary end point(s)
    a) Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
    b) Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
    c) Proportion of patients who develop antibodies (binding antibodies
    and neutralizing antibodies)
    d) Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
    E.5.1.1Timepoint(s) of evaluation of this end point
    a) 1 month after 1st dose of sargramostim
    b) 2 months after 1st dose of sargramostim
    c) 3 months after 1st dose of sargramostim
    d) 6 months after 1st dose of sargramostim. If positive at month 6, this will be continued every 6 months until the values return to baseline or up to 24 months
    E.5.2Secondary end point(s)
    a) Assessment of antibodies (antibody detection and antibody titers)
    b) Assessment of antibodies (antibody detection and antibody titers)
    c) Assessment of antibodies (antibody detection and antibody titers)
    d) Assessment of antibodies (antibody detection and antibody titers)
    e) Assessment of immunoglobulin levels
    f) Assessment of immunoglobulin levels
    g) Assessment of immunoglobulin levels
    h) Assessment of immunoglobulin levels
    i) Proportion of patients with adverse events
    l) Duration of neutropenia (time from initiation of sargramostim to recovery of ANC to ≥1500/mm^3)
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) 1 month after 1st dose of sargramostim
    b) 2 months after 1st dose of sargramostim
    c) 3 months after 1st dose of sargramostim
    d) 6 months after 1st dose of sargramostim. If positive at month 6, this will be continued
    every 6 months until the values return to baseline up to 24 months
    e) 1 month after 1st dose of sargramostim
    f) 2 months after 1st dose of sargramostim
    g) 3 months after 1st dose of sargramostim
    h) 6 months after 1st dose of sargramostim. If
    antibodies are positive at month 6, the level of immunoglubolins will be assesed every 6
    months until the antibodies level return to baseline or up to 24 months
    i) Up to 24 months
    l) Up to 42 days after first day of sargramostim administration
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 No
    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 Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Bulgaria
    Croatia
    Czech Republic
    Hungary
    Italy
    Romania
    Russian Federation
    Serbia
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 165
    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)
    none
    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 Decision2015-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-17
    P. End of Trial
    P.End of Trial StatusCompleted
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