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    Summary
    EudraCT Number:2007-006416-32
    Sponsor's Protocol Code Number:GETH/GEL-RAP-2007-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-18
    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 number2007-006416-32
    A.3Full title of the trial
    Trasplante alogénico de progenitores hematopoyéticos de donante no emparentado tras acondicionamiento no mieloablativo e inmunosupresión postrasplante con Rapamicina

    Alogenic transplantation of unrelated donor hematopoyetic progenitors under nonmieloablative conditions and inmunosuppression with Rapamicina
    A.4.1Sponsor's protocol code numberGETH/GEL-RAP-2007-01
    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 GEL-TAMO
    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 Yes
    D.2.1.1.1Trade name Rapamune
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd.
    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 nameRapamicina/ Sirolimus
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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 No
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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
    Neoplasias hematológicas, mieloides y linfoides, susceptibles de ser tratadas con trasplante alogénico de células progenitoras de donante no emparentado.

    Podrán incluirse pacientes varones y mujeres entre 40 y 60 años de edad o aquellos que aun siendo más jóvenes tengan una condición comórbida que impida el uso del trasplante alogénico mieloablativo convencional y que cumplan los criterios de inclusión respecto a su estado o enfermedad
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018799
    E.1.2Term GVHD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Describir la incidencia acumulativa y características de la enfermedad de injerto contra huésped (EICH) agudo y crónico en el primer año, en pacientes sometidos a alo-TPH (trasplante alogénico de progenitores hematopoyéticos) con acondicionamiento de intensidad reducida (AIR) y profilaxis de EICH con rapamicina.
    E.2.2Secondary objectives of the trial
    1.Comparar los resultados con una serie de pacientes ya evaluados, que reciben una profilaxis para EICH basada en CsA y MMF. No solo nos centraremos en la incidencia de EICH sino específicamente evaluaremos la incidencia y severidad de EICH aguda y crónica.
    2.Describir la supervivencia global y la mortalidad relacionada con el trasplante a día 30, 100 y al año postrasplante.
    3.Describir la supervivencia libre de evento a 1 año. Definiendo como evento a la recaida, muerte o no respuesta.
    4.Describir la velocidad de injerto y los días de ingreso requeridos.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Pacientes mayores de 40 años de edad o aquellos que, con menos edad, presenten algún dato de comorbilidad pretrasplante que contraindique la realización de un trasplante alogénico mieloablativo.
    2. Edad inferior a 60 años.
    3. Ausencia de donante emparentado adecuado.
    4. Alguna de las siguientes patologías:
    - Síndromes linfoproliferativos crónicos tipo leucemia linfática crónica o linfoma no Hodgkin que puedan beneficiarse de recibir un trasplante alogénico y no dispongan de un donante emparentado histocompatible.
    - LMA en primera remisión completa con cualquiera de los siguientes factores pronósticos:
    a) Citogenética de mal pronóstico.
    b) Duplicación en tandem interna de FLT 3.
    c) Necesidad de 2 ciclos de inducción para llegar a la remisión completa.
    d) LMA secundaria.
    - LLA con t (9; 22) o alteraciones en 11q23.
    - Mieloma múltiple con deleción en el cromosoma 13, alteraciones en IgH [t(4,14), t(14,16), t(14,20)], a nivel de p53, cariotipo complejo o antecedente de recaída tras trasplante autólogo.
    - Leucemias agudas en segunda o sucesivas remisiones completas.
    - LMC en fase crónica o acelerada tras fracaso del tratamiento con tirosin kinasas.

    5. Los pacientes deberán cumplir los siguientes requisitos generales:
    - Estado general < 3 (Zubrod, ECOG o WHO)
    - FEV1 > 39%, DLCO y FVC > 39% de los valores teóricos.
    - Bilirrubina total y transaminasas < 3 x el valor máximo normal, salvo que sea atribuible a la hemopatía de base.
    - Creatinina < 2 x el valor máximo normal y aclaramiento > 40 mL/ min salvo que sea atribuible a su hemopatía de base.
    - No evidencia de cardiopatía sintomática, cirrosis ni hepatitis activa.
    - Serología negativa para VIH.
    - Consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Alteración de la función hepática o renal.
    2. Presencia de patologías graves que impidan tratamientos con quimioterapia.
    3. Pacientes con más de 1 mismatched de 8 antígenos (HLA A, B, C y DRB1 analizados por biología molecular).
    4. Infección por VIH.
    5. Antecedentes de otra neoplasia además de las especificadas en los criterios de inclusión.
    6. No haber firmado el consentimiento informado.
    7. Mujeres gestantes o con riesgo de estar embarazadas.
    E.5 End points
    E.5.1Primary end point(s)
    Se evaluará la profilaxis de EICH en condiciones de intensidad reducida utilizando rapamicina y tacrolimus como terapia inmunosupresora al primer año después de trasplante. Para describir la incidencia de EICH aguda y crónica se usarán las escalas de gradación establecidas por consenso (NIH Consensus Project).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Yes
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Historic group
    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 concerned4
    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
    Los resultados se discutirán con los miembros de los servicios implicados. El protocolo se interrumpirá si se cumplen cualquiera de las siguientes circunstancias:
    - Mortalidad relacionada con el procedimiento de 3/5 ó 6/10 pacientes.
    - EICH aguda ≥ grado III en 3/5 ó 5/10 pacientes.
    - Fallo o rechazo del implante hematológico en 2/5 ó 3/10 pacientes.
    - Falta de inclusión de un mínimo de 10 pacientes en los primeros 18 meses desde su aprobación y distribución.
    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 months
    E.8.9.1In the Member State concerned days
    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) 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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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 Decision2008-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-01-11
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