Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-020814-27
    Sponsor's Protocol Code Number:65091-06093
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-14
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2010-020814-27
    A.3Full title of the trial
    Empirical versus pre-emptive (diagnostic-driven) antifungal therapy of patients treated for haematological malignancies or receiving an allogeneic stem cell transplant. A therapeutic open label phase III strategy study of the EORTC Infectious Diseases and Leukemia Groups
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Empirical versus pre-emptive (diagnostic-driven) antifungal therapy of patients treated for haematological malignancies or receiving an allogeneic stem cell transplant. A therapeutic open label phase III strategy study of the EORTC Infectious Diseases and Leukemia Groups
    A.4.1Sponsor's protocol code number65091-06093
    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 SponsorEORTC
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisation for Research and Treatment of Cancer
    B.5.2Functional name of contact pointMedical Department
    B.5.3 Address:
    B.5.3.1Street AddressAvenue E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number3227741611
    B.5.5Fax number3227713545
    B.5.6E-maileortc@eortc.be
    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 Cancidas 50mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme 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.3.4Pharmaceutical 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 INNCASPOFUNGIN ACETATE
    D.3.9.1CAS number 179463-17-3
    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) 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 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 Yes
    D.3.11.13.1Other medicinal product typeSemi-synthetic lipopeptide synthesized from a fermentation product of Glarea lozoyensis
    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
    Invasive fungal infection in patients with hematological malignancies.
    E.1.1.1Medical condition in easily understood language
    Invasive fungal infection in patients with hematological malignancies.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10017544
    E.1.2Term Fungemia
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is to compare two strategies, namely an empirical approach (fever driven) (EAT, arm A) versus pre-emptive (diagnostic driven) (PAT, Arm B) approach, for starting antifungal therapy (with caspofungin) for managing patients treated with chemotherapy for attaining remission induction of acute myeloid leukemia or myelodysplastic syndrome or myeloablation to prepare for an allogeneic HSCT, by assessing the survival rates 42 days (6 weeks) after initial randomization. The intent is to show the non-inferiority of the pre-emptive approach.
    E.2.2Secondary objectives of the trial
    Secondary objectives are linked to Translational Research:
    - To evaluate clinical validity and utility of a standardized Aspergillus PCR proposed by the ISHAM Working Group EAPCRI.
    - To evaluate clinical validity and utility of beta-D-glucan.
    - To determine the occurrence of SNP and the predictive value of SNP for identifying patients at higher risk of developing invasive fungal infection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18 years or older.
    - Start within 3 days before randomization, remission induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is newly diagnosed or in first relapse after hematological remission lasting for a minimum duration of 6 months OR start within 3 days before randomization, myeloablative conditioning regimen to prepare for an allogeneic HSCT. Permissible conditioning regimens are outlined in Appendix E.
    - Planned hospital admission for the duration of the neutropenic phase (ANC< 0.5 x 109 /L).
    - Planned oral or intravenous (I.V.) fluconazole for Candida prophylaxis at the dose of 400 mg/day; no other antifungal systemic prophylaxis is allowed.
    - Patients with childbearing potential must have a negative serum pregnancy test and use effective contraceptive methods during the treatment period and for at least 3 months after the last study treatment.
    - Female subjects who are lactating should discontinue nursing prior to the first dose.
    - Adequate contraception in men.
    - Patients of childbearing/ reproductive potential should use adequate birth control measures as defined by the investigator. By adequate birth control measures should be understood highly effective methods as defined by the Note 3 of the note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95):"A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
    such as implants, injectables, combined oral contraceptives, some IDUs, sexual abstinence or
    vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on contraceptives should be addressed."
    - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
    - Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
    E.4Principal exclusion criteria
    - Previous or current history of proven or probable IFD.
    - Current clinical diagnosis of pneumonia.
    - Serious uncontrolled concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol.
    - History of allergy or any adverse reaction to echinocandin drugs (caspofungin, micafungin, or anidulafungin).
    - Inadequately treated infection at study entry.
    - Documented HIV infection.
    - Concomitant inclusion on other clinical trial using an investigational drug for infectious disease.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival at 42 days i.e. 6 weeks after randomization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    42 days i.e. 6 weeks after randomization
    E.5.2Secondary end point(s)
     Overall survival at 84 days after randomization.
     Development of proven or probable IFD during the 42 days (6 weeks) and 84 days (12 weeks)
    following randomization.
     Correct management, according to allocated treatment arm (i.e. appropriate administration of
    caspofungin in compliance to protocol, and compliance to the treatment strategy) during the 42 days (6
    weeks) and 84 days after randomization.
     Survival free of fungal infection during the 42 and the 84 days following randomization.
     Safety as evaluated by AEs and SAEs by CTCAE criteria v4.0.
     Number of days under caspofungin treatment or under another antifungal treatment administered after
    caspofungin (evaluation will be done at day 42 and day 84 after randomization).
     Costs related to the strategy for initiating antifungal treatment and monitor antifungal treatment during
    the 42 days and the 84 days following randomization.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All endpoints will be assessed at 2 specific time points: 42 days after randomization and 84 days after randomization.
    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 Yes
    E.6.13.1Other scope of the trial description
    translational research and cost-effectiveness
    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 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 Yes
    E.8.2.3.1Comparator description
    Comparing both methods
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Croatia
    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
    End of study occurs when both of the following criteria have been satisfied:
    1. All randomized patients have been followed up until day 84.
    2. The database has been fully cleaned and frozen for this analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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.1.1.2Preterm 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: 556
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 504
    F.4.2.2In the whole clinical trial 556
    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)
    At physician's discretion, in the best interest of the patient.
    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 Decision2012-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-04
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 23:38:05 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA