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    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-006601-25
    Sponsor's Protocol Code Number:ZAR2007
    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:2008-02-19
    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 number2007-006601-25
    A.3Full title of the trial
    Estudio abierto, multicéntrico, aleatorizado en fase II, para evaluar la eficacia de tratamiento tras la respuesta terapéutica inicial al régimen R-CHOP en pacientes con linfoma folicular no tratados previamente. Consolidación con una dosis de 90Y Ibritumomab tiuxetan (Zevalin®) frente a tratamiento de mantenimiento con Rituximab (MabThera®)
    A.4.1Sponsor's protocol code numberZAR2007
    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 SponsorFUNDACION PETHEMA
    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 holderBayer Schering Pharma, 13342 Berlin, Alemania
    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 nameZevalin
    D.3.4Pharmaceutical form Kit for radiopharmaceutical preparation
    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 INNIbritunomab tiuxetan
    D.3.9.1CAS number 174722-31-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.6
    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) 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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 MabThera®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma AG
    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 nameMabThera
    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.3.8INN - Proposed INNRituximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number10 mg/ml
    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) 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 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 folicular en pacientes no tratados previamente
    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
    Evaluar el beneficio del tratamiento de consolidación con 90Y Ibritumomab tiuxetan (Zevalin®) o de mantenimiento con rituximab (MabThera®) respecto a la supervivencia libre de progresión (SLP) tras la inducción de respuesta con quimioterapia más rituximab en pacientes con linfoma folicular sin tratamiento previo y con criterios de tratamiento
    E.2.2Secondary objectives of the trial
    Evaluar los siguientes parámetros de manera global y según el grupo de tratamiento post-inducción (consolidación o mantenimiento):
    - la supervivencia global (SG) y la supervivencia causa-específica
    - Supervivencia libre de evento
    - Tiempo hasta el siguiente tratamiento
    - Mayor tasa de Respuestas Completas tras la consolidación o mantenimiento
    - Estudio de calidad de vida
    - Perfil de seguridad de ambos regímenes post-inducción
    - Estudio fármaco-económico (análisis de coste-efectividad)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Linfoma folicular confirmado histológicamente de grado 1, 2 ó 3a, (véase el apéndice A) con una biopsia del ganglio linfático realizada en un plazo de 4 meses antes de la entrada en el estudio. El material debe estar disponible para la posible revisión de patología central (Apéndice B). La biopsia de otro tejido resultará aceptable si es imposible obtener tejido linfático.
    • Pacientes no tratados previamente. Los pacientes previamente en observación y en espera pueden entrar en el ensayo si se dispone de una biopsia reciente que confirme la histología (obtenida en el plazo de los últimos 4 meses).
    • Estadio de Ann Arbor II, III o IV.
    • Pacientes con alguno de los siguientes síntomas o signos que indican necesidad de tratamiento según los criterios del GELF:
    o Masa ganglionar o extraganglionar (excepto el bazo) >7 cm en su diámetro mayor
    o Síntomas B
    o LDH o B2-microglobulina séricas elevadas
    o Afección de al menos 3 territorios ganglionares (cada uno con un diámetro mayor a 3 cm)
    o esplenomegalia
    o síndrome compresivo
    o derrame pleural / peritoneal
    o Evidencia de insuficiencia medular secundaria a infiltración por el linfoma
    • Edad >=18 años y <=75 años.
    • Estado general <=2 en la escala de ECOG (véase el apéndice C)).
    • Función hematológica adecuada en un plazo de 28 días antes del registro (a menos que las anomalías estén relacionadas con la extensión del linfoma), que incluye:
    Hemoglobina >= 8,0 g/dl (5,0 mmol/L)
    Recuento absoluto de neutrófilos (RAN) >= 1,5 x 109/L
    Recuento de plaquetas >=100 x 109/L
    • Las mujeres no podrán estar en el periodo de lactancia, deberán utilizar métodos anticonceptivos eficaces, no podrán estar embarazadas y deben acceder a no quedar embarazadas durante su participación en el ensayo y durante los 12 meses siguientes. Los varones deben comprometerse a no engendrar niños durante su participación en el ensayo y durante los 12 meses siguientes.
    • Consentimiento informado por escrito previo a la inclusión en el estudio.
    E.4Principal exclusion criteria
    • Transformación a linfoma de grado alto (secundario a un LF de “grado bajo”).
    • Linfoma folicular de grado 3b.
    • Linfoma folicular primario de la piel o del tracto gastro-intestinal
    • Historia de enfermedad del SNC (o bien linfoma del SNC o meningitis linfomatosa).
    • Tratamiento previo del linfoma folicular
    • Pacientes que toman regularmente corticosteroides durante al menos las últimas 4 semanas, a menos que se administren a una dosis equivalente a <= 20 mg/día de prednisona.
    • Pacientes con cánceres anteriores o concomitantes, excepto cáncer de piel distinto al melanoma o cáncer de cuello uterino adecuadamente tratado in situ.
    • Cirugía mayor (excluyendo biopsia del ganglio linfático) en un plazo de 28 días antes del registro.
    • Función renal alterada: Creatinina sérica > 2,0 mg/dl (197 micromol/L),
    • Función hepática alterada: bilirrubina total > 2,0 mg/dl (34 micromol/L), AST (SGOT) > 3 x el límite superior normal, a menos que estas anomalías estén relacionadas con el linfoma.
    • Infección conocida por VIH o infección activa por VHB o VHC <= 4 semanas en el registro. A estos efectos, se considerará infección activa la positividad de cualquier marcador de hepatitis B, excepto los secundarios a vacunación
    • Enfermedades subyacentes graves, que podrían afectar a la capacidad del paciente para participar en el ensayo (por ejemplo, infección en curso, diabetes mellitus no controlada, úlceras gástricas, enfermedad autoinmune activa). Queda al criterio del investigador.
    • Esperanza de vida < 6 meses.
    • Hipersensibilidad conocida a Ibritumomab tiuxetan, cloruro de itrio, rituximab u otras proteínas murinas o a alguno de los excipientes.
    • Tratamiento dentro de un ensayo clínico en un plazo de 30 días previos a la entrada en el ensayo.
    • Cualquier otro estado médico o psicológico coexistente que descarte la participación en el estudio o comprometa la capacidad para dar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia libre de progresión (SLP) desde la entrada en el estudio: La SLP se define como el tiempo desde la entrada en el estudio hasta la progresión, recaída, muerte por cualquier causa, o institución de un nuevo tratamiento anti-linfoma (quimioterapia, radioterapia o inmunoterapia).
    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 No
    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 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 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 No
    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 concerned40
    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 months96
    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 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) 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state122
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 122
    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 Decision2008-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
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