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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2007-002733-36
    Sponsor's Protocol Code Number:ML21135
    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:2007-07-06
    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 number2007-002733-36
    A.3Full title of the trial
    “Estudio multicéntrico, no aleatorizado, abierto, en Fase II, para valorar la eficacia y seguridad de la inducción con Rituximab, Fludarabina, Ciclofosfamida seguido de Rituximab como mantenimiento (R-Fc-Rm) en el tratamiento de la leucemia linfática crónica en primera línea”
    A.4.1Sponsor's protocol code numberML21135
    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 SponsorROCHE FARMA S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    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
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRituximab
    D.3.9.1CAS number 174722-31
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    LEUCEMIA LINFÁTICA CRÓNICA
    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 la eficacia del tratamiento en términos de tasa de respuesta completa obtenida tras el régimen R-FC como tratamiento de LLC en primera línea.
    E.2.2Secondary objectives of the trial
    •Evaluar la eficacia del tratamiento en función de la tasa de respuestas con enfermedad residual mínima negativa, obtenida tras el régimen R-FC.
    •Evaluar la supervivencia libre de progresión, supervivencia libre de tratamiento y la supervivencia global.
    •Evaluar la toxicidad asociada al régimen R-FC+ Rituximab de mantenimiento.
    •Analizar el impacto pronóstico de las alteraciones biológicas y moleculares en la evolución de la enfermedad (CD38, ZAP-70, mutaciones de los genes IgVH).
    •Evaluar la tasa de respuestas y la duración de las mismas, en función de los marcadores genéticos anómalos (deleción 6q, deleción 11q22-q23, trisomía 12, deleción 13q14, deleción p53).
    •Analizar el impacto pronóstico de la enfermedad mínima residual en la evolución de la enfermedad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Edad ( >18 años y ≤ 70 años)
    2. Pacientes afectos de leucemia linfática crónica de acuerdo con los criterios diagnósticos establecidos según la clasificación de la OMS (Apéndice B)
    3. LLC activa definida por la existencia de uno de los siguientes criterios (Apéndice C):
    - Presencia de síntomas relacionados con progresión de enfermedad: pérdida de peso > 10% en los últimos 6 meses, ó fiebre > 38ºC durante 2 semanas sin evidencia de infección, ó fatiga extrema, ó sudoración nocturna sin evidencia de infección
    - Adenopatías o mazacotes adenopáticos gigantes (>10 cm. de diámetro) o adenopatías de crecimiento progresivo
    - Esplenomegalia gigante (>6 cm por debajo del reborde costal) o esplenomegalia progresiva
    - Linfocitosis progresiva (incremento > 50% en periodo de 2 meses) ó tiempo de duplicación linfocitario (anticipado) < 6 meses
    - Evidencia de fallo medular progresivo manifestado por desarrollo o empeoramiento de anemia y/o trombopenia
    4. Estado general adecuado (Escala ECOG < 2) (Apéndice D)
    5. Pacientes que hayan otorgado su consentimiento informado por escrito
    E.4Principal exclusion criteria
    1. Pacientes que han recibido tratamiento previo para la LLC
    2. Enfermos con LLC en transformación a formas citológicas o histológicas de mayor agresividad (leucemia prolinfocítica, linfoma de células grandes, linfoma de Hodgkin)
    3. Pacientes con enfermedades cardíacas, pulmonares, neurológicas, psiquiátricas o metabólicas graves y no debidas a la LLC
    4. Pacientes en tratamiento sistémico y continuado con corticosteroides
    5. Alteración de la función hepática (bilirrubina, GOT/ GPT o Gamma-GT (>2 LSN) no atribuible a la LLC
    6. Alteración de la función renal (creatinina > 1,5 LSN) o aclaramiento de creatinina < 50 ml/min
    7. Enfermos afectos de otra neoplasia maligna (excepto carcinoma cutáneo localizado)
    8. Pacientes con anemia o trombocitopenia activas, de origen autoinmune.
    9. Enfermos con cualquier infección grave en actividad
    10. Las embarazadas no pueden participar en el estudio. Las mujeres potencialmente fértiles deberán aportar una prueba de embarazo en suero/orina negativas en los siete días previos al inicio del tratamiento.
    11. Las mujeres lactantes no podrán participar en el estudio.
    12. Pacientes con serología positiva conocida del virus de la inmunodeficiencia humana (VIH) o con otras condiciones de inmunodepresión grave.
    13. Pacientes que hayan recibido esteroides en los 28 días previos al estudio.
    14. Pacientes con serología positiva para el virus de la hepatitis B (VHB) (HBsAg) o frente al virus de la hepatitis C (VHC) (HBcAc).
    15. Pacientes que no puedan seguir controles en régimen ambulatorio
    16. Participación simultánea en otro estudio
    E.5 End points
    E.5.1Primary end point(s)
    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 No
    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 Information not present in EudraCT
    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 concerned36
    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 Information not present in EudraCT
    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
    La finalización total del estudio se define como la fecha de la última visita de seguimiento a los 36 meses de finalizar el tratamiento, o antes si todos los pacientes se han retirado del estudio.
    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 months8
    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 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 2007-07-06. 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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 Decision2007-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-20
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