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    Summary
    EudraCT Number:2009-009422-92
    Sponsor's Protocol Code Number:PRODECYTE
    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:2010-02-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-009422-92
    A.3Full title of the trial
    Ensayo clínico multicéntrico, prospectivo, abierto y con control histórico para determinar la eficacia y seguridad de la administración de DepoCyte (citarabina liposómica inyectable) como profilaxis de la infiltración neuromeníngea en pacientes entre 16 y 30 años con leucemia aguda linfoblástica de riesgo estándar
    A.4.1Sponsor's protocol code numberPRODECYTE
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundación PETHEMA
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCITARABINA
    D.3.9.1CAS number 147-94-4
    D.3.9.2Current sponsor codePRODECYTE
    D.3.9.3Other descriptive nameCYTARABINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Profilaxis de la infiltración neuromeníngea en pacientes entre 16 y 30 años con leucemia aguda linfoblástica de riesgo estándar
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    lDeterminar la eficacia y seguridad de DepoCyte® como única profilaxis por vía IT de la recaída neuromeníngea de los pacientes entre 16 y 30 años diagnosticados de LAL de riesgo estándar tratados con el esquema de quimioterapia del protocolo PETHEMA LAL-RI-08
    E.2.2Secondary objectives of the trial
    -Evaluar tolerabilidad de DepoCyte® como profilaxis del SNC por vía IT en pacientes entre 16 y 30 años con LAL de riesgo estándar
    -Comparar frecuencia de recaída en SNC en pacientes entre 16 y 30 años con LAL de riesgo estándar tratados con esquema de quimio del prot PETHEMA LAL-RI-08 y que reciben DepoCyte® como profilaxis única del SNC por vía IT con la observada en un grupo histórico de pacientes de idéntico riesgo que fueron tratados con el prot PETHEMA LAL-RI/96 que incluye misma quimio sistémica y doble de administraciones quimio intratecal triple
    -Evaluar frecuencia de recaídas sistémicas en pacientes entre 16 y 30 años con LAL de riesgo estándar tratados con el esquema de quimio del prot PETHEMA LAL-RI-08 y que reciben DepoCyte® como profilaxis única del SNC por vía IT y compararla con la observada en los pacientes de idéntico riesgo tratados con el prot PETHEMA LAL-RI/96 que incluye la misma quimio sistémica y el doble de administraciones de quimio intratecal triple
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •El paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo clínico.
    •El paciente, o su representante legal, debe firmar voluntariamente el consentimiento informado antes de la realización de cualquier prueba del ensayo que no forme parte de su atención habitual.
    •Edad entre 16 y 30 años
    •Diagnosticados de LAL de riesgo estándar no tratados previamente. La LAL de riesgo estándar está definida por todos los siguientes criterios:
    -Leucocitos < 25x109/L
    -Ausencia de alteraciones citogenéticas que comporten mal pronóstico:
    * t(9;22) o demostración del reordenamiento BCR-ABL
    * Alteraciones en 11q23, o demostración del reordenamiento ALL1-AF4
    •En caso de mujer en edad fértil, el test de embarazo debe ser negativo y la paciente debe comprometerse a seguir un método de contracepción seguro
    E.4Principal exclusion criteria
    •Infiltración inicial de SNC (definida como presencia de blastos en el examen tras citocentrifugación de una muestra de LCR con un recuento celular de más de 5 células/microL, en ausencia de punción traumática [más de 10 hematíes/mL], o bien como clínica neurológica sugestiva de infiltración neuromeníngea y prueba de imagen compatible, en ausencia de blastos en el LCR)
    •LAL tipo L3 con fenotipo B maduro (sIg +) o con las alteraciones citogenéticas características de la LAL de Burkitt (t[8;14], t[2;8], t[8;22]).
    •LAL con t(9;22) o reordenamiento BCR-ABL.
    •Leucemias agudas bifenotípicas y bilineales.
    •Leucemias agudas indiferenciadas.
    •Pacientes con antecedentes de enfermedad coronaria, valvular o cardiopatía hipertensiva.
    •Pacientes con hepatopatía crónica
    •Pacientes con insuficiencia respiratoria crónica
    •Pacientes con insuficiencia renal no debida a la LAL
    •Pacientes con trastornos neurológicos graves, no debidos a la LAL
    •Pacientes con un estado general afectado (grados 3 y 4 de la escala de la OMS), no atribuible a la LAL.
    •Mujeres embarazadas o en periodo de lactancia
    •Pacientes que estén actualmente en otro ensayo clínico o hayan recibido cualquier agente en investigación en los 30 días previos a la inclusión en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Para evaluar la eficacia se valorará la frecuencia de recaídas neuromeníngeas, durante el primer año de tratamiento (en el que se administra el fármaco experimental), durante el segundo año de tratamiento y durante el año después de finalizado el tratamiento de la LAL. El análisis de eficacia consistirá en una comparación de la probabilidad actuarial de recidiva en el sistema nervioso central de los pacientes del estudio con las del grupo control histórico
    Así mismo, la evaluación de la seguridad se basará en la comparación de las toxicidades observadas durante la administración de Depocyte con las del grupo control histórico. Se realizará un seguimiento de los efectos adversos acontecidos durante el estudio.
    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 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
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 Yes
    E.8.1.7.1Other trial design description
    controlado con control histórico
    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
    Grupo histórico pacientes idéntico riesgo con tto misma quimio sistemica y doble ad quimio IT triple
    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 concerned22
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    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 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-02-23. Yes
    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 state85
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 85
    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 Decision2009-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-07-31
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