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    Summary
    EudraCT Number:2008-007725-39
    Sponsor's Protocol Code Number:MALT2008-01
    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:2009-03-10
    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 number2008-007725-39
    A.3Full title of the trial
    ESTUDIO MULTICENTRICO FASE II,
    NO ALEATORIZADO, DE RITUXIMAB EN COMBINACIÓN CON BENDAMUSTINA COMO PRIMER TRATAMIENTO SISTÉMICO EN LINFOMA DE CÉLULAS B DE LA ZONA MARGINAL EXTRAGANGLIONAR DEL TEJIDO LINFOIDE ASOCIADO A MUCOSAS (MALT)
    A.4.1Sponsor's protocol code numberMALT2008-01
    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 Ribomustin
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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
    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 INNBendamustina
    D.3.9.1CAS number 16506-27-7
    D.3.9.3Other descriptive nameTreanda
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    D.3.11.13.1Other medicinal product typeAgente alquilante antineoplásico del grupo de los agentes alquilantes bifuncionales.
    D.IMP: 2
    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 MABTHERA 100 mg concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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 Concentrate for 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.3.9.1CAS number 174722-31-7
    D.3.9.3Other descriptive nameRITUXIMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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 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 hodgkiniano marginal de tipo MALT en una primera línea de inmunoquimioterapia.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10060707
    E.1.2Term MALT lymphoma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la supervivencia libre de acontecimiento (SLA) (fracaso del tratamiento o muerte por cualquier causa) en todos los pacientes de la combinación de rituximab y bendamustina en linfoma de células B de la zona marginal extraganglionar del tejido linfoide asociado a mucosas (MALT).
    E.2.2Secondary objectives of the trial
    1. Tasa de respuesta completa y parcial en todos los pacientes.
    2. Duración de la respuesta (tiempo hasta la recidiva o progresión) en los pacientes que responden
    3. Determinar la toxicidad aguda y a medio plazo de los tratamientos efectuados.
    4. Supervivencia libre de progresión (SLP) (progresión de la enfermedad o muerte a causa del linfoma) en todos los pacientes.
    5. Supervivencia global de los pacientes.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Título: Subestudio Genético para estudiar diferentes polimorfismos en relación con toxicidad y respuesta a la combinación de Rituximab y Bendamustina en pacientes con linfoma MALT.

    Objetivo: La finalidad de este subestudio es estudiar diferentes polimorfismos en relación con toxicidad y respuesta a la combinación de Rituximab y Bendamustina en pacientes con linfoma MALT.

    Fecha: 28/10/2009
    Versión: FINAL
    E.3Principal inclusion criteria
    Los pacientes deben cumplir TODOS los criterios siguientes para poder ser incluidos en el ensayo:
    1. Diagnóstico confirmado histológicamente de linfoma de células B de la zona marginal extraganglionar de tipo MALT, CD20-positivo, desarrollado en cualquier localización extraganglionar, definido de acuerdo con la clasificación de la OMS (apéndice A).
    2. Enfermedad en cualquier estadio (I-IV de Ann Arbor) (véase próximo criterio y apéndice B).
    3. Enfermedad de novo en todas las localizaciones extraganglionares. En los linfomas primarios cutáneos o gástricos se permite haber realizado tratamiento local/específico según los siguientes criterios:
    En linfomas cutáneos los criterios de elegibilidad son:
    o recurrente tras terapia local (incluye corticoides tópicos, PUVA, cirugía y/o radioterapia).
    En linfomas gástricos los criterios de elegibilidad son:
    o H. pylori negativos, tanto de novo o tras recaída a tratamiento local.
    o H. pylori positivos al diagnóstico tras fracaso a tratamiento con antibióticos, que incluye:
    Progresión endoscópica, radiológica o histológica
    Enfermedad estable con persistencia del linfoma a más de 12 meses del inicio de la erradicación de H. pylori
    Recaída, sin reinfección por H. pylori
    Fracaso al tratamiento de primera línea con antibióticos
    o H. pylori positivos al diagnóstico de novo, a excepción de aquellos con enfermedad estrictamente localizada en la mucosa, submucosa o musculares propia (estadios I de Ann Arbor pero T1-2 del TNM adaptado; ver apéndice B). Todos aquellos pacientes con enfermedad en la serosa (T3 del TNM adaptado) o más allá, son elegibles.
    4. Ausencia de transformación histológica a linfoma de células grandes (véase apéndice C).
    5. Edad >/= 18 años y < 85 años.
    6. Estado funcional ECOG 0-2 (véase apéndice D).
    7. Enfermedad mesurable o evaluable.
    8. Esperanza de vida de al menos, 1 año.
    9. Consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Haber sido tratados previamente con quimioterapia o haber recibido previamente inmunoterapia con cualquier anticuerpo monoclonal anti-CD20.
    2. Haber recibido radioterapia durante las 6 últimas semanas.
    3. Haber realizado tratamiento con corticosteroides durante los 28 últimos días, a menos que se haya administrado un tratamiento crónico con prednisona a una dosis de <20 mg/día para indicaciones distintas al linfoma o síntomas relacionados con el linfoma.
    4. Pacientes con alteración grave de la función renal (creatinina > 2,5 v.n.) o hepática (bilirrubina o ALT/AST > 2,5 v.n.), a menos que sea debida al linfoma.
    5. Pacientes con disfunción de médula ósea (leucocitos < 3,0x109/l, neutrófilos <1,5x109/l, plaquetas <100x109/l), a menos que sea debida al linfoma.
    6. Pacientes con enfermedades cardiacas, pulmonares, neurológicas o metabólicas graves y no debidas al linfoma.
    7. Afectación del sistema nervioso central (SNC) por linfoma.
    8. Infección activa por VHB y/o VHC.
    9. Infección por VIH.
    10. Diagnóstico previo de neoplasias durante los 5 años anteriores, excepto neoplasia intraepitelial cervical tipo 1 (CIN1) o cáncer de piel no melanomatoso localizado.
    11. Pacientes con enfermedades psiquiátricas graves que puedan interferir con su capacidad para seguir el estudio.
    12. Pacientes que no puedan seguir controles regulares en régimen ambulatorio.
    13. Pacientes con hipersensibilidad conocida a cualquier componente de los medicamentos.
    14. Mujeres embarazadas o en periodo de lactancia. Las mujeres potencialmente fértiles se incluirán previo test de embarazo en suero/orina negativo. Utilizarán un método anticonceptivo eficaz que se mantendrá durante 1 año tras finalizar el tratamiento.
    15. Pacientes que hayan recibido algún fármaco, agente o procedimiento en investigación, o que hayan participado en otro estudio de investigación durante los 30 días anteriores al comienzo del tratamiento con la medicación del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia libre de acontecimiento (SLA)

    Tiempo transcurrido desde la primera dosis de RB hasta el fracaso del tratamiento o muerte por cualquier causa.

    Se entiende por fracaso de tratamiento: la aparición de estable, progresión o la interrupción del tratamiento por toxicidad inaceptable (Acontecimiento adverso grave)
    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 Yes
    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 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) 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 concerned20
    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 years4
    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 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) 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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-03-10. Yes
    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 state60
    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 Decision2009-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
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