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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2007-006440-22
    Sponsor's Protocol Code Number:ALORTINE-EC06007
    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:2008-03-24
    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 number2007-006440-22
    A.3Full title of the trial
    Ensayo intergrupos (GELTAMO/GETH) Fase II, Abierto, Multicéntrico, de uso de Alemtuzumab (MabCampath®) en Trasplante Alogénico de Donante no Emparentado con Acondicionamiento de Intensidad Reducida en pacientes con neoplasias hematológicas.
    A.4.1Sponsor's protocol code numberALORTINE-EC06007
    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 SponsorGrupo Español de Linfomas y transplantes Autólogos de Médula Osea (GELTAMO)
    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 MabCampath®
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe BC
    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.3.4Pharmaceutical form Intravenous 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.3.8INN - Proposed INNAlemtuzumab
    D.3.9.3Other descriptive nameMabCampath
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 100
    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 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) 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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal
    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
    Pacientes con neoplasias hematológicas tanto linfoides como mieloides cuya enfermedad tiene indicación de trasplante alogénico de intensidad reducida de donante no emparentado.
    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
    Analizar los resultados de incidencia y severidad de EICH aguda y crónica y de supervivencia libre de enfermedad con el uso de Alemtuzumab (MabCampath®) en trasplante hematopoyético de donante no emparentado con acondicionamiento de intensidad reducida.
    E.2.2Secondary objectives of the trial
    •Mortalidad relacionada con el trasplante
    •Tiempo hasta recaída o progresión
    •Supervivencia global
    •Infecciones oportunistas
    •Calidad de vida
    •Análisis de quimerismo postrasplante
    •Reconstitución inmune postrasplante
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes con neoplasias hematológicas mieloides o linfoides con indicación de trasplante alogénico:
    1.1. Linfoma no Hodgkin de tipo folicular, linfoma del manto y otros linfomas de bajo grado (por ej., linfoplasmacítico, extranodal o de la zona marginal) de alto riesgo:
    •Enfermedad que no logra remisión completa con quimioterapia que incluya Fludarabina o anti-CD20.
    •Recaída tras trasplante autólogo.
    •No candidatos a trasplante autólogo en 2ª RC (por ej., fracaso de movilización, o infiltración medular persistente).
    1.2. Leucemia linfática crónica de mal pronóstico: Del 11q, Del 17p, cariotipo complejo, Síntomas B, Citopenia progresiva por infiltración medular, Linfocitosis o linfadenopatía o esplenomegalia progresiva.
    1.3. Linfoma de alto grado transformado de un linfoma no Hodgkin de bajo grado o de una leucemia linfática crónica.
    1.4. Linfoma T periférico de alto riesgo, con IPI≥2 no subsidiario de trasplante autólogo, o recaído tras trasplante autólogo.
    1.5. Enfermedad de Hodgkin de alto riesgo primariamente refractaria, recaída en pacientes no subsidiarios de trasplante autólogo o recaída tras trasplante autólogo
    1.6. Leucemia aguda mieloblástica (LAM) de alto riesgo en 1ª RC, o LAM  2ª RC, incluyendo LAM post-SMD y LAM secundaria.
    1.7. Leucemia aguda linfoblástica (LAL) de alto riesgo por pobre respuesta a quimioterapia de inducción (>10% blastos día +14 ó no RC día +28-35), o por criterios citogenéticos: Ph+ o 11q23.
    1.8. Síndromes mielodisplásicos (SMD) de alto riesgo tipo AREB-1 y AREB-2 con IPSS >Int-1
    2. Para inclusión en trasplante, los pacientes con LAL y LAM deberán estar en RC, los pacientes con SMD deberán tener <10% blastos en la MO, y los pacientes con neoplasias linfoides deberán demostrar quimiosensibilidad previa con RP o RC.
    3. Pacientes de 40 a 65 años de edad. Se podrán incluir pacientes fuera de este rango de edad en función de los criterios de los centros participantes.
    4. Pacientes en la población de estudio que carecen de donante familiar, y con un posible donante no emparentado compatible (9/10 por tipaje HLA de alta resolución de 10 alelos: HLA-A, B, C, DRB1, DQB1) para asignar a los pacientes a un subgrupo de riesgo.
    5. Consentimiento informado firmado.
    6. No cumplir ninguno de los criterios de exclusión descritos a continuación.
    E.4Principal exclusion criteria
    1. Alteración orgánica no relacionada con la enfermedad de base:
    •función hepática (≥ x3 UNL)
    •función renal (FGL <40ml/min)
    •función cardiaca (FEVI <40%)
    •función respiratoria (DLCO & FVC <40% de lo esperado).
    2. Infección por el VIH.
    3. Enfermedad en progresión previa al trasplante o que no cumpla los criterios de respuesta descritos en el apartado 6.2.2.
    4. No haber firmado el consentimiento informado.
    5. Otras patologías graves que contraindiquen tratamiento con quimioterapia.
    6. Mujeres embarazadas y/o en período de lactancia o con riesgo de embarazo por anticoncepción inadecuada
    7. Esperanza de vida <6 meses.
    8. Deficiencia mental o psiquiátrica que impida la comprensión y consentimiento apropiados al tratamiento.
    9. Hipersensibilidad manifestada como reacción anafiláctica a alguno de los FÁRMACOS empleados en el ensayo
    E.5 End points
    E.5.1Primary end point(s)
    Análisis de incidencia y severidad
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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) 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 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 Information not present in EudraCT
    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 concerned12
    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 years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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.1.3Elderly (>=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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 Decision2008-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 22:36:31 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA