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    Summary
    EudraCT Number:2009-011090-33
    Sponsor's Protocol Code Number:LENA-LMA-5
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-05-05
    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 number2009-011090-33
    A.3Full title of the trial
    ESTUDIO PILOTO FASE II, MULTICÉNTRICO, NO ALEATORIZADO, PARA VALORAR LA EFICACIA Y LA SEGURIDAD DE LENALIDOMIDA EN INDUCCIÓN Y POST-INDUCCIÓN EN PACIENTES CON LEUCEMIA MIELOIDE AGUDA DE NOVO (LMA) CON LA ANOMALÍA CITOGENÉTICA MONOSOMÍA 5 O DELECIÓN 5q
    A.4.1Sponsor's protocol code numberLENA-LMA-5
    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 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 REVLIMID 25 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE 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 Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDA
    D.3.9.3Other descriptive nameLENALIDOMIDA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 mieloide aguda (LMA) de novo con anomalía citogenética monosomía 5 (-5) o deleción 5q (del (5q)) asociada.
    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
    1-Evaluar la eficacia de lenalidomida post-inducción en pacientes con LMA de novo con la anomalía citogenética deleción 5q (del(5q)) o monosomía 5 (-5), que hayan obtenido remisión completa tras la quimioterapia de inducción convencional.
    2- Evaluar la eficacia de lenalidomida como inducción en pacientes con LMA de novo con la anomalía citogenética deleción 5q (del(5q)) o monosomía 5 (-5), que hayan presentado resistencia (remisión parcial o resistencia absoluta) tras la quimioterapia de inducci
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad de lenalidomida post-inducción en pacientes con LMA de novo con la anomalía citogenética deleción 5q (del(5q)) o monosomía 5 (-5)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Confirmación diagnóstica de LMA de acuerdo con los criterios de la WHO12 (Anexo 4).
    2. LMA de novo (es decir: pacientes sin antecedentes documentados de tratamiento previo con antineoplásicos, radioterapia u otros agentes para enfermedades oncológicas, hematológicas o inmunológicas, relacionados con el desarrollo de LMAs secundaria; y pacientes sin LMA secundaria a SMD primario con del(5q) o -5 [antecedentes documentados de SMD primario con transformación a LMAs]).
    3. Confirmación diagnóstica de la anomalía del(5q) o -5, asociada o no a otras anomalías citognéticas. No es necesario que la del(5q) incluya la banda 5q31.
    4. Pacientes que hayan recibido un ciclo de quimioterapia de inducción consistente en una combinación clásica de antraciclina y citarabina (con o sín etopósido como tercer agente asociado), con independencia de la respuesta obtenida.
    5. Pacientes en los que se haya evaluado la respuesta a la quimioterapia de inducción con antraciclina y citarabina (con o sín etopósido como tercer agente asociado), siendo clasificados según los criterios del IWG12.
    6. Pacientes &#8804;60 años no elegibles para trasplante alogénico de progenitores hematopoyéticos.
    7. Pacientes >60 años no elegibles para trasplante alogénico de progenitores hematopoyéticos, o elegibles pero que no dispongan de hermano HLA-idéntico.
    8. Aceptar el uso de algún método contraceptivo eficaz, en pacientes en edad fértil con potencial reproductor (ver Sección 6.5 sobre plan de prevención de embarazos).
    9. Capacidad para entender y firmar voluntariamente el formulario de consentimiento informado.
    10. Edad &#8805; 18 años en el momento de firmar el formulario de consentimiento informado.
    11. Capacidad y disposición para cumplir el calendario de visitas del estudio.
    E.4Principal exclusion criteria
    1. LMA secundaria a tratamientos con agentes citostáticos o inmunosupresores, síndrome mielodisplásico u otra enfermedad neoplásica.
    2. LMA con las anomalías citogenética t(15;17), t(8;21), t(16;16) o inv(16) o sus correspondientes reordenamientos moleculares.
    3. Pacientes que hayan recibido inducción a la remisión con un régimen diferente a citarabina + antraciclina +/- etopósido.
    4. Pacientes &#8804;60 años elegibles para trasplante alogénico de progenitores hematopoyéticos.
    5. Pacientes >60 años elegibles para trasplante alogénico de progenitores hematopoyéticos y que dispongan de hermano HLA-idéntico.
    6. Pacientes en los que no se haya valorado la respuesta a la quimioterapia de inducción (remisión completa, remisión parcial o resistencia (ver Tabla 6).
    7. ECOG 3-4.
    8. Cualquiera de las siguientes anomalías analíticas
    &#61607; Creatinina sérica > 2,0 mg/dl (177 mmol/l).
    &#61607; Aspartato aminotransferasa sérica (AST)/ transaminasa glutámico oxalacético sérica (SGOT) o alanina aminotransferasa (ALT)/ transaminasa glutamato piruvato sérica (SGPT) > 5,0 x límite superior de la normalidad (ULN).
    &#61607; Bilirrubina total sérica > 3 mg/dl.
    9. Paciente con serología para VIH positiva conocida. No es necesario realizar test VIH en fase de selección.
    10. Toda afección o enfermedad psiquiátrica grave que impida al paciente firmar el formulario de consentimiento informado o comporte para el paciente un riesgo inaceptable en caso de participar en el estudio.
    11. Toda afección o enfermedad orgánica grave que comporte para el paciente un riesgo inaceptable en caso de participar en el estudio.
    12. Uso previo de agentes quimioterápicos citotóxicos o agentes experimentales (agentes no disponibles comercialmente) para el tratamiento de LMA.
    13. Mujeres embarazadas o en período de lactancia (ver Sección 6.5 sobre plan de prevención de embarazos).
    E.5 End points
    E.5.1Primary end point(s)
    - Duración de la remisión en aquellos pacientes que en el momento de iniciar el ensayo estuvieran en primera remisión completa (gruo A)
    - Tasas de respuesta a Lenalidomina de acuerdo con los criterios de consenso del IWG (remisión completa, remisión parcial) y tasas de mejoría hematológica (reducción de blastos> 50%), en aquellos pacientes que en el momento de iniciar el ensayo presentaran resistencia absoluta o remisión parcial (grupo B).
    - Supervisión global al año y a los 2 años (desde el inicio del tratamiento) en todos los pacientes.
    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 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 concerned2
    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 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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    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 Decision2009-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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