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    Summary
    EudraCT Number:2007-003302-10
    Sponsor's Protocol Code Number:GELTAMO- Z-RIC - Allo
    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:2007-08-02
    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 number2007-003302-10
    A.3Full title of the trial
    Trasplante alogénico de progenitores hematopoyéticos tras acondicionamiento no mieloablativo con melfalan ,fludarabina y zevalin en pacientes con linfoma No Hodgkin B agresivo
    A.4.1Sponsor's protocol code numberGELTAMO- Z-RIC - Allo
    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 SponsorGELTAMO (Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea)
    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 Zevalin
    D.2.1.1.2Name of the Marketing Authorisation holderSchering AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameY-90 Ibritumomab tiuxetan
    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.3.11 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 Yes
    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
    Linfoma no Hodgkin de células B, CD20+, agresivo (linfoma difuso de células grandes, linfoma de células del manto, linfoma de células B transformado), de alto riesgo, con indicación de trasplante alogénico.
    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
    Supervivencia Libre de Progresión
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad (toxicidad, mortalidad relacionada con el trasplante y el injerto) asociada al uso de 90Y ibritumomab tiuxetan como parte del acondicionamiento No Mieloablativo en pacientes sometidos a trasplante alogénico de progenitores hematopoyéticos de sangre periférica de donante emparentado
    Evaluar la respuesta al tratamiento según los criterios de Cheson (Cheson B, et al. JCO 25, 570.2007)
    Evaluar la Supervivencia Global
    Evaluar la Tasa de Recaída
    Evaluar la incidencia de Enfermedad Inejerto contra Huésped aguda y Crónica
    Evaluar la reconstitución hematológica, inmunológica y quimerismo
    Evaluar el impacto de la Respuesta Clínica Completa determinada por citometría de flujo y PET sobre la supervivencia libre de progresión.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Consentimiento informado por escrito.
    2.Linfoma B confirmado histológicamente de los siguientes subtipos:
    LBDCG,
    linfoma Folicular grado 3 b,
    Linfoma del Manto
    Linfoma B transformado
    Linfoma de Burkitt en pacientes no candidatos a un trasplante alogénico convencional
    3.Linfoma B CD20+ de alto riesgo definido por:
    •Haber alcanzado menos de una RP tras dos líneas de quimioterapia
    •Recaída tras autotrasplante
    •Presencia de enfermedad detectada por una técnica metabólica (PET/TC ó TC + PET) antes o después del trasplante autólogo
    •Incapacidad de recoger células progenitoras suficientes para realizar un trasplante autólogo.
    4.Enfermedad estable en el momento del trasplante
    5.Edad entre 18 años y 65 años
    6.Performance status (ECOG) < 2.
    7.Adecuada función pulmonar normal. ( DLCO>=30% )
    8.Fracción de eyección ventricular izda, (FEVI) medida por ventriculografía o por ecocardiograma > =40%.
    9. Función hepática y renal normal con una creatinina <_2mg/dl y Bi ≤ 1.5 mg/dL y Fosfatasa alkalina 2.5 x LSN, AST, ALT ≤ 2.5 x LSN ( ≤ 5 x ULN si infiltración hepática).
    E.4Principal exclusion criteria
    Terápia previa con radiofármacos
    Linfoma asociado a VIH
    Presencia de anticuerpos humanos contra ratón (HAMA) o antiquiméricos (HACA)
    Incapacidad del paciente para seguir el protocolo
    Hipersensibilidad al 90Y-itritumomab tiuxetan
    Presencia de patologías graves que impidan tratamientos con quimioterapia
    Mujeres gestantes o con riesgo de embarazo por medidas anticonceptivas inadecuadas.
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia Libre de Progresión
    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 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 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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    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 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 concerned13
    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 years3
    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 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 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 Decision2007-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
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