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    The EU Clinical Trials Register currently displays   42314   clinical trials with a EudraCT protocol, of which   6969   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:2009-017829-19
    Sponsor's Protocol Code Number:LFNK
    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:2009-12-17
    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 number2009-017829-19
    A.3Full title of the trial
    Ensayo clínico fase II controlado de inmunoterapia combinada con linfocitos efectores autólogos en pacientes con linfoma no Hodgkin folicular en tratamiento de mantenimiento con rituximab tras respuesta a primera línea de quimioterapia
    A.4.1Sponsor's protocol code numberLFNK
    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 SponsorInstituto Científico y Tecnológico de Navarra
    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 No
    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 nameLinfocitos efectores autólogos obtenidos a partir de células linfomononucleadas expandidas con IL-2
    D.3.2Product code Linfocitos efectores autólogos
    D.3.4Pharmaceutical form Suspension for injection
    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 INNLinfocitos efectores autólogos obtenidos a partir de células linfomononucleadas expandidas con IL-2
    D.3.10 Strength
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1000000000
    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 Yes
    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 no Hodgkin folicular
    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 impacto del tratamiento sobre la supervivencia libre de progresión
    E.2.2Secondary objectives of the trial
    1- Evaluar su seguridad
    2- Evaluar su impacto sobre otros parámetros clínicos de eficacia
    Supervivencia global y supervivencia causa-específica
    Supervivencia libre de acontecimiento
    Tiempo hasta el siguiente tratamiento
    Tasa de respuestas completas tras el tratamiento
    Calidad de vida medida según cuestionarios EORTC
    3- Caracterizar el producto celular y correlacionar los hallazgos con la eficacia clínica:
    4- Estudiar parámetros biológicos que puedan predecir la susceptibilidad al tratamiento:
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    |• Linfoma folicular CD20-positivo confirmado histológicamente de grado 1, 2 ó 3a, (véase el apéndice A)
    • Capacidad para otorgar consentimiento informado y expresar su deseo de cumplir todos los requisitos del protocolo durante el periodo de estudio
    • Pacientes no tratados previamente. El tratamiento con R-CHOP de inducción debe ser el de primera línea para los pacientes que sean incluidos en el estudio.
    • Tratamiento de mantenimiento previsto con ciclos de rituximab trimestrales
    • Estadio de Ann Arbor II, III o IV antes de recibir el tratamiento de quimioterapia con R-CHOP.
    • Pacientes con alguno de los siguientes síntomas o signos que indican necesidad de tratamiento según los criterios del GELF antes de recibir el tratamiento de quimioterapia con R-CHOP:
    o Masa ganglionar o extraganglionar (excepto el bazo) >7 cm en su diámetro
    mayor o Síntomas B
    o LDH o p2-microglobulina séricas elevadas
    o Afección de al menos 3 territorios ganglionares (cada uno con un diámetro
    mayor a 3 cm) o esplenomegalia osíndrome compresivo o derrame pleural / peritoneal
    o Evidencia de insuficiencia medular secundaria a infiltración por el linfoma
    • El paciente debe de haber alcanzado una respuesta parcial o completa al tratamiento de inducción.
    • 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
    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 distinto al tratamiento de inducción estándar con R-CHOP
    • 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 , cáncer de cuello uterino adecuadamente tratado in situ u otra neoplasia de extensión limitada, tratada de forma curativa y libre de progresión durante tres o más años.
    • Función renal alterada: Creatinina sérica > 2,0 mg/dl (197 u.mol/L),
    • Función hepática alterada: bilirrubina total > 2,0 mg/dl (34 umol/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.
    • Enfermedades subyacentes graves que a juicio del investigador puedan 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).
    • Esperanza de vida < 6 meses.
    • Embarazo o lactancia
    • Hipersensibilidad conocida a 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
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years7
    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 2009-12-17. 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 state29
    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 Decision2011-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-30
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