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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:2012-000233-39
    Sponsor's Protocol Code Number:IIBSP-CSF-2011-141
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-000233-39
    A.3Full title of the trial
    Tratamiento de la leucemia mieloide aguda de novo con la combinación de idarrubicina en dosis creciente, citarabina y sensibilización (?priming?) con G-CSF. Estudio prospectivo en fase I/II de toxicidad y eficacia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tratamiento de la leucemia mieloide aguda de novo con la combinación de idarrubicina en dosis creciente, citarabina y G-CSF.
    A.4.1Sponsor's protocol code numberIIBSP-CSF-2011-141
    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 SponsorInstitut de Recerca de l?Hospital de la Santa Creu i Sant Pau
    B.1.3.4CountrySpain
    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 supportBeca Ministerio de Salud
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca HSCSP
    B.5.2Functional name of contact pointRomy Rodriguez
    B.5.3 Address:
    B.5.3.1Street AddressC. Sant Antoni Mª Claret, 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number349329190001969
    B.5.5Fax number34935537812
    B.5.6E-mailrrodriguezmu@santpau.cat
    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 Zavedos
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameZavedos
    D.3.2Product code PR 1
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    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 INNIDARUBICIN
    D.3.9.1CAS number 58957-92-9
    D.3.9.2Current sponsor codePR1
    D.3.9.3Other descriptive nameZalvedos
    D.3.9.4EV Substance CodeSUB08111MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Leucemia Mieloide Aguda de novo
    E.1.1.1Medical condition in easily understood language
    Leucemia Mieloide Aguda en primer diagnóstico
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000835
    E.1.2Term Acute leukemia
    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
    Principal:
    Identificar la dosis máxima de idarrubicina en combinación con citarabina y G-CSF que origina una tasa de RC igual o superior al 65% con toxicidad tolerable.
    E.2.2Secondary objectives of the trial
    Toxicidad hematológica
    Toxicidad gastrointestinal y hepática
    Toxicidad cardiaca
    Fiebre e infecciones
    Complicaciones pulmonares
    Duración de la hospitalización
    Mortalidad en inducción y causas de muerte
    Recaídas a los 6 meses de obtenida la RC
    Supervivencia a los 9 meses del diagnóstico
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Se recogerán células y suero para almacenarlas en el Banco de Tumores y en la seroteca, de cara a futuros estudios, previo consentimiento por parte de los pacientes.
    E.3Principal inclusion criteria
    Firma del consentimiento informado
    Pacientes con LMA de nuevo diagnóstico, clasificada según los criterios de la OMS.
    Edad mayor o igual a 18 años y menor o igual a 70 años.
    E.4Principal exclusion criteria
    Pacientes tratados previamente por su LMA con quimioterapia distinta de hidroxiurea.
    Leucemia promielocítica aguda con t(15;17).
    Crisis blástica de la leucemia mieloide crónica.
    Leucemias que aparecen después de otras neoplasias mieloproliferativas.
    Leucemias que sobrevienen después de síndromes mielodisplásicos de más de 6 meses. presencia de otras enfermedades neoplásicas en actividad.
    LMA secundarias a tratamiento quimio-radioterápico por otras neoplasias.
    Funciones renal y hepática anormales, con cifra de creatinina y/o bilirrubina 2 veces superior al valor límite normal, excepto cuando la alteraciones sean atribuibles a la leucemia.
    Pacientes con fracción de eyección muy disminuida (inferior al 45%), insuficiencia cardiaca sintomática, o ambas del valor normal del centro.
    Pacientes con enfermedad neurológica o psiquiátrica grave concomitante.
    Positividad para el VIH.
    Pacientes embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Obtención de la remisión completa (RC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Día + 28 Post primera y segunda inducción (cuando aplique)
    E.5.2Secondary end point(s)
    Toxicidad secundaria a la administración de idarrubicina:
    Toxicidad hematológica (OMS)
    Toxicidad gastrointestinal y hepática (OMS)
    Toxicidad cardiaca (OMS)
    Fiebre e infecciones
    Complicaciones pulmonares (OMS)
    Duración de la hospitalización
    Mortalidad en inducción (MRT)
    Recaídas a los 6 meses de la RC (incidencia acumulada) (RI)
    Supervivencia a los 9 meses del diagnóstico (probabilidad actuarial) (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Post inducción (1º y 2º cuando aplique, recaída), Mes 3, Mes 6 y visitas de seguimiento
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Ensayo clínico fase I/II prospectivo, abierto, simple, multicéntrico, no aleatorizado, en 3 cohortes
    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 concerned5
    E.8.5The trial involves multiple Member States No
    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
    Última de visita de seguimiento del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned 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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state45
    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)
    Tratamiento postremisión habitual, según protocolo LMA-12 del grupo CETLAM
    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 Decision2012-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-13
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA