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    Summary
    EudraCT Number:2009-012973-37
    Sponsor's Protocol Code Number:IPR/21
    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:2010-12-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-012973-37
    A.3Full title of the trial
    TK008: Estudio aleatorizado de fase III sobre el trasplante de células hematopoyéticas haploidéntico con o sin una estrategia de apoyo con linfocitos HSV-TK donados, en pacientes con leucemia aguda de alto riesgo.
    A.3.2Name or abbreviated title of the trial where available
    TK008
    A.4.1Sponsor's protocol code numberIPR/21
    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 SponsorMolMed S.pA.
    B.1.3.4CountryItaly
    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 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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/03/168
    D.3 Description of the IMP
    D.3.1Product nameHSV-tk lymphocytes
    D.3.2Product code MM100
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeIPR/21
    D.3.10 Strength
    D.3.10.1Concentration unit EID50 50% Embryo Infective Dose
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.8 to 1.2
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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 Yes
    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
    Los pacientes aptos para HCT haploidéntico afectados por leucemias agudas en primera remisión completa o remisión completa subsiguiente y con alto riesgo de recaída.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10060930
    E.1.2Term Acute leukaemia in remission
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la incidencia acumulada a 1 año de mortalidad sin recidiva (MSR) en pacientes con leucemia de alto riesgo sometidos a trasplante de células hematopoyéticas haploidéntico seguido de una estrategia de apoyo con linfocitos HSV-TK donados o a trasplante de células hematopoyéticas haploidéntico estándar
    E.2.2Secondary objectives of the trial
    Comparar la supervivencia global (SG) en los dos grupos de tratamiento
    Comparar el tiempo hasta la reconstitución inmunitaria de los linfocitos T
    Comparar la tasa de injerto funcionante
    Comparar la incidencia acumulada de EICH (enfermedad del injerto contra el receptor) de grado II-IV
    Comparar la incidencia acumulada de EICH crónica extensa
    Comparar la incidencia acumulada de recidiva (IAR)
    Comparar la supervivencia libre de enfermedad (SLE)
    Comparar la incidencia y la duración de episodios infecciosos y la mortalidad asociada a infección
    Evaluar la toxicidad aguda y a largo plazo asociada a las infusiones de HSV-TK
    Evaluar la calidad de vida (CV) y la utilización de servicios sanitarios (USS) en los dos grupos
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Título: Farmacoeconomía
    Versión :A
    Fecha:2009-11-04
    Objetivo:resumir y evaluar las diferencias en los dos grupos de tratamiento con respecto a los recursos utilizados, en particular los utilizados para el diagnóstico, seguimiento y tratamiento de los eventos más importantes (EICH aguda y crónica, episodios infecciosos)

    Calidad de vida
    Título:Evaluación de la calidad de vida
    Versión:A
    Fecha:2009-11-04
    Objectivo: resumir y evaluar las diferencias entre los grupos de tratamiento en términos de ben
    E.3Principal inclusion criteria
    Edad ? 18 años
    *Cualquiera de las condiciones siguientes:
    - LMA y LLA en primera remisión completa (RC) con riesgo alto de recidiva basado en unos factores pronóstico negativos
    -LMA y LLA en segunda RC o RC subsiguiente
    -LMA secundaria en RC
    *Ausencia de donante emparentado o no emparentado HLA idéntico
    *Condiciones clínicas estables y esperanza de vida > 3 meses
    EF según la escala ECOG ? 2
    *Los pacientes, o tutores legales, y los donantes deben firmar un consentimiento informado en el que se indique que saben que se trata de un estudio de investigación y que se les ha informado de sus posibles efectos beneficiosos y reacciones adversas tóxicas
    E.4Principal exclusion criteria
    Criterios de exclusión:
    * Pacientes con una enfermedad o complicación potencialmente mortal diferente de la enfermedad de base
    *Contraindicación de un trasplante de células hematopoyéticas haploidéntico definida por el Investigador
    *Pacientes con enfermedad activa del SNC
    *Embarazo o lactancia. Los pacientes varones y mujeres con capacidad reproductora (es decir, menopáusicas durante menos de 1 año y sin esterilización quirúrgica) deben utilizar métodos anticonceptivos eficaces durante todo el estudio Las mujeres en edad fértil deben dar negativo en una prueba de embarazo (en suero u orina) realizada en los 14 días previos a su registro.

    Criterios de exclusión para la infusiónde HSV-Tk:
    1.Infecciones que requieran la administración de ganciclovir, valganciclovir o aciclovir en el momento de la infusión. Los linfocitos HSV-TK se pueden administrar 24 horas después de la suspensión del tratamiento antiviral
    2.EICH que requiera tratamiento inmunosupresor sistémico
    3.Tratamiento inmunosupresor sistémico en curso después de trasplante de células hematopoyéticas haploidéntico
    4.Administración de G-CSF (factor estimulante de colonias de granulocitos) después de trasplante de células hematopoyéticas haploidéntico
    5.Linfocitos CD3+ ? 100/µl el día de la infusión experimental prevista después de trasplante de células hematopoyéticas haploidéntico.
    E.5 End points
    E.5.1Primary end point(s)
    Comparar la incidencia acumulada a 1 año de mortalidad sin recidiva (MSR) en pacientes con leucemia de alto riesgo sometidos a trasplante de células hematopoyéticas haploidéntico seguido de una estrategia de apoyo con linfocitos HST-TK donados o a trasplante de células hematopoyéticas haploidéntico estándar.
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Evaluación de calidad de vida
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Haploidéntico trasplante de células madre hematopoyéticas (sin HSV-tk)
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    por fecha de finalización del estudio se entiende la última visita al centro solo cuando la visita de cierre se haya realice, todos los datos estén validados y la documentación del estudio haya sido revisada.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 2010-12-13. 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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 152
    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 Decision2011-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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