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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-019562-91
    Sponsor's Protocol Code Number:GS-EU-131-0247
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-019562-91
    A.3Full title of the trial
    A Phase 3, Double-Blind, Multicenter, Randomized, Placebo Controlled Study to Assess the Efficacy, Safety and Tolerability of Prophylactic Liposomal Amphotericin B (AmBisome®) for the Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Remission Induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the ability of AmBisome to prevent the development
    of serious invasive infections caused by fungi in patients diagnosed with
    acute lymphoblastic leukemia receiving the initial phase of their
    chemotherapy treatment.
    A.3.2Name or abbreviated title of the trial where available
    AmbiGUARD
    A.4.1Sponsor's protocol code numberGS-EU-131-0247
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01259713
    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 International Ltd
    B.1.3.4CountryUnited Kingdom
    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 International Ltd
    B.4.2CountryUnited Kingdom
    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 Information
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington
    B.5.3.3Post codeCambridge
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4412238973004496
    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 AmBisome 50 mg Pulver zur Herstellung einer Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAmBisome
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMPHOTERICIN B
    D.3.9.1CAS number 1397-89-3
    D.3.9.3Other descriptive nameAMPHOTERICIN B
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Invasive fungal infections (IFI) in subjects with Acute Lymphoblastic Leukemia (ALL) undergoing remission induction chemotherapy
    E.1.1.1Medical condition in easily understood language
    Serious infections caused by fungi in patients receiving early, high dose
    chemotherapy for the treatment of acute lymphoblastic leukaemia.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10017533
    E.1.2Term Fungal infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To determine the prophylactic efficacy of AmBisome compared to placebo in preventing IFIs in subjects with ALL undergoing remission-induction chemotherapy.
    E.2.2Secondary objectives of the trial
    • To determine the safety and tolerability of prophylactic AmBisome in subjects with ALL
    undergoing remission-induction chemotherapy.
    • To determine the impact of IFI prevention on the efficacy of remission-induction
    chemotherapy in subjects with ALL.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Randomized subjects from a subset of sites will be given the option to consent to a 40 subject PK sub-study to determine the minimum levels of AmBisome during the twice weekly dosing. The PK monitoring will consist of drawing an additional blood sample to assess AmBisome levels just prior to each infusion of study drug for four weeks (8 study drug infusions), starting just prior to the second infusion. With the 2:1 randomization schedule this is expected to provide minimum concentration levels of AmBisome obtained with twice weekly dosing, for approximately 26 subjects.
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
    • Newly diagnosed ALL receiving an ALL chemotherapy regimen that typically induces at least 10 days of neutropenia, defined as an absolute neutrophil count (ANC) < 500 cells/mm3 or 0.5x109 cells/L
    Note: Subjects with lymphoblastic lymphoma or any malignancy other than ALL are NOT eligible for this study.
    • Age ≥ 18 years
    • Able to have all screening tests performed quickly to ensure results can be obtained and evaluated before randomization so that the first dose of randomized study drug for IFI prophylaxis can be administered no later than 5 days after the start of remission-induction chemotherapy
    Note: With respect to this timing, pre-remission induction treatment (i.e. pre-phase) with a minimally or non-myelosuppressive regimen for up to one week is not considered to constitute the beginning of remission induction chemotherapy.
    • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
    • Known hypersensitivity to amphotericin B or AmBisome, the metabolites or formulation excipients, in particular known history of anaphylactic reaction to amphotericin B or AmBisome or any of its metabolites or formulation excipients.
    • Known hypersensitivity to the excipients of the placebo formulation
    • Current fever (≥38°C) unless fungal causes have clearly been
    excluded, e.g. negative lung and sinus imaging, documented drug-fever,
    or response to anti-bacterial antibiotic treatment.
    • Subjects with proven, probable or possible IFI (according to EORTC/MSG criteria) at screening or in subject history
    • Pulmonary infiltrates
    • Concomitant or previous treatment with an antifungal drug within the previous 30 days unless the plasma level is below the limit of detection or at least 5 half-lives of the antifungal has elapsed since the treatment was given
    • Serum creatinine > 2 x the upper limit of the normal range (ULN)
    • Grade 3 Liver function test results (prior to starting remission induction chemotherapy): alanine aminotransferase or aspartate aminotransferase > 5 x ULN; total bilirubin > 2.5 x ULN
    • Any severe co morbidity other than underlying hematological disease (ALL), which in the investigator’s judgment may interfere with study evaluations or affect the subject’s safety.
    • Subjects who have taken any investigational drug in the last 30 days prior to screening, with the exception of ALL chemotherapy investigational products being used as part of the subject’s current ALL treatment protocol.
    • Pregnant or nursing females.
    • Subjects with a prior history of a malignancy that was treated with a myeloablative chemotherapy regimen are NOT eligible for this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to assess antifungal prophylaxis efficacy of AmBisome 5 mg/kg compared to placebo.
    The primary efficacy endpoint in support of this objective is the proportion of subjects with proven or probable IFIs during remission-induction chemotherapy for ALL.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interim analysis for efficacy when 50% of subjects have completed the study.
    Final analysis when all subjects have completed the protocol defined last patient last visit.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints to be assessed during remission induction chemotherapy for ALL are as follows:
    • The proportion of subjects with pulmonary infiltrates
    • The proportion of subjects diagnosed with proven or probable IFIs according to the EORTC/MSG criteria, as assessed by the investigator.
    • Time to diagnosis of proven or probable IFIs according to the EORTC/MSG criteria, as assessed by the IDRB
    • The proportion of subjects diagnosed with proven invasive fungal infections, according to the EORTC/MSG criteria as assessed by the
    IDRB.
    • The proportion of subjects diagnosed with probable invasive fungal infections, according to the EORTC/MSG criteria as assessed by the IDRB.
    • The proportion of subjects requiring antifungal treatment according to the protocol guidelines prior to starting consolidation chemotherapy.
    • The proportion of subjects who die due to fungal infection; causality as assessed by the IDRB.
    • The proportion of subjects who die due to fungal infection; causality as assessed by the investigator.
    Secondary endpoints to evaluate the potential impact of IFI prevention on the efficacy of remission induction chemotherapy for ALL are as follows:
    • The median duration of remission induction chemotherapy (i.e., the time from beginning of remission induction chemotherapy until the beginning of consolidation therapy)
    • The proportion of subjects with complete remission at the end of remission induction
    E.5.2.1Timepoint(s) of evaluation of this end point
    Final analysis when all subjects have completed the protocol defined last patient last visit.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    Belgium
    France
    Greece
    Italy
    Austria
    Portugal
    Argentina
    Brazil
    Germany
    Spain
    Israel
    Switzerland
    Turkey
    E.8.7Trial has a data monitoring committee Yes
    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
    Last patient, last visit.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 344
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 258
    F.4.2.2In the whole clinical trial 354
    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)
    Eligible subjects will be able to start consolidation therapy. If a subject is still neutropenic, the site should continue to monitor and treat the subject according to their normal clinical practice.
    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 Decision2010-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-29
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