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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2005-005719-83
    Sponsor's Protocol Code Number:ATGfamilystudy
    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:2012-03-15
    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 number2005-005719-83
    A.3Full title of the trial
    Prophylaxis of chronic graft-versus-host disease (cGvHD) with or without anti-Tlymphocyte-globulin (ATG Fresenius) prior allogeneic peripheral stem cell transplantation from HLA-identical siblings after myeloablative conditioning in patients with acute leukemia: a randomized phase III-study
    Profilaxis de la Enfermedad injerto contra huésped (EICH) crónica con o sin inmunoglobulina anti-linfocitos T (ATeGe) previo a trasplante alogénico de progenitores hematopoyéticos de sangre periférica procedente de donante emparentado HLA idéntico en pacientes con leucemia aguda que han recibido régimen de preparación mieloablativo: Fase III de un estudio aleatorizado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prophylaxis of chronic graft-versus-host disease (cGvHD) with or without anti-Tlymphocyte-globulin (ATG Fresenius) prior allogeneic peripheral stem cell transplantantion
    Profilaxis de la Enfermedad injerto contra huésped (EICH) crónica con o sin inmunoglobulina anti-linfocitos T (ATeGe) previo a trasplante alogénico de progenitores hematopoyéticos de sangre
    A.3.2Name or abbreviated title of the trial where available
    ATGfamilystudy
    ATGfamilystudy
    A.4.1Sponsor's protocol code numberATGfamilystudy
    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 SponsorUniversitary Hospital Hamburg
    B.1.3.4CountryGermany
    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 supportProf. Nikolaus Krogër
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clínico Universitario de Valencia
    B.5.2Functional name of contact pointDr. Carlos Solano Vercet
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Blasco Ibañez, 17
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46010
    B.5.3.4CountrySpain
    B.5.4Telephone number0034963862625
    B.5.5Fax number0034963622238
    B.5.6E-mailcarlos.solano@uv.es
    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 AteGe-Fresenius
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Biotech GmbH
    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 nameAteGe-Fresenius
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPParenteral use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMMUNGLOBULIN
    D.3.9.1CAS number 8000012-66-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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
    Acute lymphoblastic and myeloid leukemia
    Leucemia linfoide y mieloide aguda
    E.1.1.1Medical condition in easily understood language
    lymphoblastic and myeloid leukemia
    Leucemia linfoide y mieloide
    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 10000842
    E.1.2Term Acute lymphatic leukaemia
    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
    Comparison of cumulative incidence of chronic cGVHD (localized or extended) after allogeneic peripheral blood stem cell donor from HLA-identical with or without ATeGe-Fresenius as revised Seattle criteria of Lee et al.
    Comparación de incidencia acumulada de EICH crónica (localizada o extensa) posterior a trasplante alogénico de progenitores hematopoyéticos de sangre periférica procedente de donante HLA-idéntico con o sin ATeGe-Fresenius según la revisión de Seattle de los criterios de Lee et al.
    E.2.2Secondary objectives of the trial
    -Comparison of acute cGvHD on day +100 after transplantation.
    -Comparison of quality of life between both treatment arms according to the EORTC.
    -Comparison of treatment-related mortality on day +100 and day +365 after allogeneic peripheral blood stem cell transplantation.
    -Comparison of toxicity according to the Bearman-Score.
    -Comparison of overall survival post-transplant at two years.—
    -Comparison of progression-free survival post-transplant at two years.—
    -Comparison of engraftment (leukocyte count > 1.0 x 109/l, platelet count > 20 x 109/l).
    -Comparison of incidence of bacterial, viral, fungal and protozoal infection at day +100 and at one year after transplantation.
    -Comparison of chronic-GvHD-free survival between the two treatment arms at two years.
    -Incidence of adverse events (AEs) and adverse drug reactions (ADRs) between the two treatment arms.
    - Comparación de EICH aguda el día +100 posterior al trasplante.
    - Comparación de calidad de vida entre ambos grupos de tratamiento.
    - Comparación de mortalidad asociada al tratamiento el día +100 y el día +365 posterior a TPH alogénico.
    - Comparación de la toxicidad.
    - Comparación de supervivencia global post-trasplante a los dos años.
    - Comparación de supervivencia sin evidencia de progresión de la enfermedad a los dos años.
    - Comparación del tiempo de recuperación hematopoyética (número de leucocitos> 1.0x109/l, número de plaquetas >20x 109/l)
    - Comparación de incidencia de infección bacteriana, vírica, micótica y por protozoos el día +100 y un año posterior al trasplante.
    - Comparación de supervivencia libre de EICH crónica entre los grupos de tratamiento a los dos años post-trasplante.
    - Incidencia de efectos adversos y reacciones adversas entre los grupos de tratamiento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Analysis of genetic polymorphism of the gene NOD2/CARD15 and KIR-genes and related genes to predict graft-versus-host disease and transplant-associated complications.
    El análisis de polimorfismo genético del gen NOD2/CARD15 y KIR genes y genes relacionados con la predicción de injerto contra huésped crónica y trasplante asociado complicaciones
    E.3Principal inclusion criteria
    Acute myeloid leukemia in first or subsequent complete remission (de-novo or secondary AML).
    Acute lymphoblastic leukemia in first or subsequent complete remission.
    Patient's age: 18 ? 65 years.
    Myeloablative standard conditioning.
    HLA-identical sibling (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1).
    No major organ dysfunctions.
    Patient's written informed consent
    LMA en primera o subsiguiente remisión completa (RC1 y > RC1).
    LLA en primera o subsiguiente remisión completa.
    Edad del paciente: 18-65 años.
    En régimen de preparación mieloablativo.
    HLA-idénticos (HLA-A, HLA-B, HLA-DRBI y HLA-DQB1).
    No disfunción orgánica mayor.
    Pacientes que hayan firmado consentimiento informado.
    E.4Principal exclusion criteria
    No complete remission at time of randomization.
    Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as:
    o Total bilirubin, SGPT or SGOT > 5 times upper the normal level.
    o Left ventricular ejection fraction < 30 %.
    o Creatinine clearance < 30 ml/min.
    o DLCO < 35 % and/or receiving supplementary continuous oxygen.
    Positive serology for HIV.
    Pregnant or lactating women.
    Serious psychiatric or psychological disorders.
    Progressive invasive fungal infection at time of registration.
    No remisión completa en el momento de la aleatorización
    Enfermedad severa irreversible renal, hepática, pulmonar o cardiaca con:
    o Bilirrubina total, GOT o GPT > 5 veces el nivel normal
    o Fracción de eyección del ventrículo izquierdo < 30%
    o Aclaramiento de creatinina < 30ml/min
    o DLCO < 35% y/o receptores de oxigenoterapia continua
    Serología positiva a VIH
    Mujer embarazada o en periodo de lactancia
    Enfermedades psiquiátricas o psicológicas graves
    Infección micótica progresiva invasiva en el momento del registro
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic peripheral blood stem cell transplantation from HLA-identical siblings with or without anti-T-lymphocyte-globulin according to the revised Seattle criteria of Lee
    et al. and of the NIH Consensus Development Project at two years after transplantation.
    La comparación de incidencia acumulada de EICH crónica (limitada o extensa), después de alogénico de células madre de sangre periférica trasplante de hermanos HLA idénticos con o sin anti-linfocitos T-globulina de acuerdo a los criterios revisados de Seattle de Leeet al. y del Proyecto de Desarrollo de Consenso del NIH, dos años después trasplante.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two years after transplantation.
    Dos años después del trasplante
    E.5.2Secondary end point(s)
    See secondary objectives
    Ver objetivos secundarios
    E.5.2.1Timepoint(s) of evaluation of this end point
    See secondary objectives
    Ver objetivos secundarios
    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 No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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 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: 160
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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)
    Regular Monnitoring in Patients
    Seguimiento normal de los pacientes
    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 Decision2007-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
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