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    Summary
    EudraCT Number:2015-003168-35
    Sponsor's Protocol Code Number:IELSG40
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-10
    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 number2015-003168-35
    A.3Full title of the trial
    A PHASE II TRIAL ADDRESSING FEASIBILITY AND ACTIVITY OF CLARITHROMYCIN + LENALIDOMIDE COMBINATION: A FULL ORAL TREATMENT FOR PATIENTS WITH RELAPSED/REFRACTORY MUCOSA-ASSOCIATED LYMPHOID TISSUE (MALT) LYMPHOMA
    CLEO Trial
    Un ensayo clinico fase II analizando factibilidad y actividad de claritromicina más lenalidomida en combinación: Un tratamiento
    completamente oral para pacientes con linfoma de la zona marginal extranodal refractario o en recaída.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY WITH THE AIM TO EVALUATE THE ANTITUMOR ACTIVITY OF A NEW ASSOCIATION OF ORAL DRUGS, LENALIDOMIDE AND CLARITHROMYCIN IN PATIENTS WITH LYMPHOMA (MALT), WHEN STANDARD TREATMENT WITH RADIATION THERAPY, CHEMOTHERAPY AND /OR IMMUNOTHERAPY HAVE SHOWN A LACK OF EFFICACY
    Un estudio con el objetivo de evaluar la actividad antitumoral de una nueva asociación de fármacos orales, lenalidomida y claritromicina, en pacientes con linfoma (MALT), cuando el tratamiento standard con radioterapia, quimioterapia y/o inmunoterapia non han sido eficaces
    A.3.2Name or abbreviated title of the trial where available
    CLEO TRIAL
    Ensayo clinico CLEO
    A.4.1Sponsor's protocol code numberIELSG40
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIELSG - INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP
    B.1.3.4CountrySwitzerland
    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 supportCELGENE EUROPE LIMITED
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIELSG - INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP
    B.5.2Functional name of contact pointSTUDY COORDINATION OFFICE
    B.5.3 Address:
    B.5.3.1Street AddressVIA OSPEDALE 1
    B.5.3.2Town/ cityBELLINZONA
    B.5.3.3Post code6500
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041918119040
    B.5.5Fax number0041918119182
    B.5.6E-mailielsg@eoc.ch
    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 - 20MG CAPSULE HARD - ORAL USE BLISTER (PCTFE/PVC/ALU) - 21 CAPSULES
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE 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.3.1Product nameLENALIDOMIDE
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCELGENE
    D.3.9.3Other descriptive nameLENALIDOMIDE
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 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 - 15MG CAPSULE HARD - ORAL USE BLISTER (PCTFE/PVC/ALU) - 21 CAPSULES
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE 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.3.1Product nameLENALIDOMIDE
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCELGENE
    D.3.9.3Other descriptive nameLENALIDOMIDE
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 3
    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 - 10MG CAPSULE HARD - ORAL USE BLISTER (PCTFE/PVC/ALU) - 21 CAPSULES
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE 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.3.1Product nameLENALIDOMIDE
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCELGENE
    D.3.9.3Other descriptive nameLENALIDOMIDE
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 4
    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 CLARITHROMYCIN - 500MG FILM-COATED TABLETS - 14 TABLETS IN BLISTER PVC/PVDC
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT LABORATORIES
    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 nameCLARITHROMYCIN
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNCLARITHROMYCIN
    D.3.9.1CAS number 81103-11-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameCLARITHROMYCIN
    D.3.9.4EV Substance CodeSUB06641MIG
    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 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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    PATIENTS WITH MUCOSA-ASSOCIATED LYMPHOID TISSUE LYMPHOMA (MALT) FOR WHICH THE STANDARD TREATMENTS WITH RADIOTHERAPY, CHEMOTHERAPY AND /OR IMMUNOTHERAPY SHOW LACK OF EFFICACY
    Pacientes con linfoma tipo MALT (asociado a las mucosas) donde los tratamientos estandar con radioterapia, quimioterapia y/o inmunoterapia no muestran eficacia
    E.1.1.1Medical condition in easily understood language
    PTS WITH STRONG FORM OF CANCER. IT AFFECTS CELLS AND TISSUES RESPONSIBLE FOR DEFENDING THE BODY AGAINST EXTERNAL AGENTS/ DISEASE. THIS TUMOR GROWS AT EXPENSE OF LYMPHOID TISSUE IN THE MUCOUS MEMBRANES
    Pacientes con cancer agresivo. Afecta a células y tejidos responsables de defender al organismo de agentes externos y enfermedades. El tumor crece en tejido linfoide de membranas mucosas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the overall response rate (complete and partial responses) of the combination treatment of clarithromycin and lenalidomide (Revlimid) in patients with MALT lymphoma, refractory or relapsing after radiotherapy and/or chemotherapy and/or immunotherapy.
    Evaluar la tasa de respuesta global (respuesta parcial y completa) de la combinación de claritromicina y lenalidomida (Revlimid) en pacientes con linfoma MALT, refractario o en recaída después de radioterapia y/o quimioterapia y/o inmunoterapia
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety profile of the clarithromycin + lenalidomide combination, including any late adverse reactions
    2. To assess the progression-free survival after clarithromycin + lenalidomide therapy
    3. To assess the time to progression after clarithromycin + lenalidomide therapy
    4. To assess the overall survival after clarithromycin+lenalidomide therapy
    1. Evaluar el perfil de seguridad de la combinación de claritromicina y lenalidomida, incluyendo efectos adversos tardíos
    2. Evaluar la supervivencia libre de progresión después de tratamiento con la combinación de claritromicina y lenalidomida
    3. Evaluar el tiempo hasta progresión después de tratamiento con la combinación de claritromicina y lenalidomida
    4. Evaluar la supervivencia global después de tratamiento con claritromicina y lenalidomida
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Histologically verified diagnosis of MALT lymphoma arising at any extranodal site
    2) Disease refractory to or in first or greater relapse after prior radiotherapy and/or chemotherapy and/or immunotherapy
    3)Measurable or non-measurable lesions where the response is nevertheless evaluable by non-imaging means (e.g., gastric or bone marrow infiltrations)
    4) Ann Arbor Stage I-IV
    5) ECOG performance status of 0, 1 or 2
    6) Age ≥ 18 years
    7) Life expectancy of at least 3 months
    8) Adequate haematological status: ANC (absolute neutrophil count [segmented + bands]) ≥1.0 x 109/L, platelet count ≥ 75 x 109/L , haemoglobin ≥8 g/dL.
    9) Adequate cardiac, renal and liver function tests (LVEF > 40%, serum creatinine < 2.5 mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range, alkaline phosphatase < 2.5 x upper limit of normal range, serum bilirubin < 2.0 mg/dl)
    10) Patient must be willing and able to comply with the protocol for the entire study duration
    11) Female patients of childbearing potential must agree to use, and be able to comply with, effective contraception and agree to have medically supervised pregnancy tests prior to starting the study treatment and during therapy
    12) Male patients must agree to always use a condom during any sexual contact with females of reproductive potential and agree to not donate sperm while taking lenalidomide
    13) Patient must agree to abstain from donating blood while taking study drug therapy
    14) Patient must agree not to share study medication with another person and to return all unused study drug to the investigator
    15) Patient must be willing and able to comply with the protocol
    16) Patient must be capable of understanding the purpose of the study and have given written informed consent
    1. Diagnostico verificado histologicamente de linfoma MALT en cualquier sede extranodal
    2. Enferemdad refractaria o en primera o ulterior recaida tras radioterapia y/o quimioterapia y/o inmunoterpia
    3. Lesiones medibles o no medibles donde la respuesta es de todas formas evaluable por medios distintos de la imagen (por ejemplo, infiltración gastrica o de la médula ósea)
    4. Estadio Ann Arbor I-IV
    5. ECOG performance status de 0,1 o 2
    6. dad ≥ 18 años
    7.Esperanza de vida de al menos 3 meses
    8.Estado hematológico adecuado: ANC (recuento absoluto de neutrófilos [segmentado + bandas]) ≥1,0 ​​x 109 / L, recuento de plaquetas ≥ 75 x 109 / L, hemoglobina ≥8 g / dL.
    9.Pruebas de función cardíaca, renal y hepática adecuadas (FEVI> 40%, creatinina sérica <2,5 mg / dl, ALAT o ASAT <2,5 x límite superior del rango normal, fosfatasa alcalina <2,5 x límite superior del rango normal, bilirrubina sérica < 2,0 mg / dl)
    10.El paciente debe estar dispuesto y capaz de cumplir con el protocolo durante toda la duración del estudio
    11.Las mujeres con potencial reproductivo deben acordar el uso y poder cumplir con la anticoncepción efectiva y acordar la realización de pruebas de embarazo médicamente supervisadas antes de comenzar el tratamiento del estudio y durante la terapia
    12.Los pacientes varones deben aceptar usar siempre un condón durante cualquier contacto sexual con las mujeres de potencial reproductivo y aceptar no donar esperma mientras están tomando lenalidomida
    13.El paciente debe aceptar abstenerse de donar sangre mientras toma el medicamento del estudio
    14.El paciente debe acordar no compartir la medicación del estudio con otra persona y devolver todos los medicamentos del estudio no utilizados al investigador
    15.El paciente debe estar dispuesto y capaz de cumplir con el protocolo
    16.El paciente debe ser capaz de entender el propósito del estudio y haber dado su consentimiento informado por escrito
    E.4Principal exclusion criteria
    1) Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma (“high grade lymphoma”) - component
    2) Use of any investigational agent within 28 days prior to initiation of treatment
    3) History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix within the last 5 years unless in complete remission since at least 3 years
    4) Dependency on red blood cell and/or platelet transfusions
    5) HBsAg positivity
    6) Evidence of central nervous system involvement
    7) A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
    8) Severe peripheral polyneuropathy
    9) Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months and/or long QT-syndrome
    10) HIV seropositivity
    11) Presence of active opportunistic infections
    12) Pregnancy or lactation
    13) Uncontrolled diabetes mellitus
    14) Pre-existing thromboembolic conditions at study entry
    15) Known hypersensitivity to thalidomide or lenalidomide or macrolide antibiotics
    16) Presence of any contraindication reported on the Summary of Product Characteristics (SmPC) of Clarithromycin
    17) Hypersensitivity to any active principle and/or any excipient according to the contraindications reported in the SmPC of clarithromycin and in the Investigator’s Brochure (IB) of lenalidomide
    1) Linfoma histológico distinto al linfoma MALT o linfoma MALT con linfoma difuso de células grandes ("linfoma de alto grado")
    2) El uso de cualquier farmaco experimental los 28 días previos al inicio del tratamiento
    3) Historial de neoplasias malignas distintas del carcinoma de células escamosas, carcinoma basocelular de la piel o carcinoma in situ del cuello uterino en los últimos 5 años, salvo en remisión completa desde al menos 3 años
    4) Dependencia de transfusiones de glóbulos rojos y / o plaquetas
    5) HBsAg positivo
    6) Afectación del sistema nervioso central
    7) Un historial de epilepsia no controlada, trastornos del sistema nervioso central o discapacidad psiquiátrica juzgado por el investigador clínicamente significativo y que afecta negativamente al cumplimiento de los fármacos del estudio.
    8) Polineuropatía periférica grave
    9) Enfermedad cardíaca clínicamente significativa (por ejemplo, insuficiencia cardíaca congestiva, enfermedad arterial coronaria sintomática y arritmias cardiacas no bien controladas con medicación) o infarto de miocardio en los últimos 6 meses y / o síndrome de QT largo
    10) Seropositividad al VIH
    11) Presencia de infecciones oportunistas activas
    12) Embarazo o lactancia
    13) Diabetes mellitus incontrolada
    14) Condiciones tromboembólicas preexistentes en la entrada del estudio
    15) Hipersensibilidad conocida a talidomida o lenalidomida o antibióticos macrólidos
    16) Presencia de cualquier contraindicación reportada en el Resumen de Características del Producto (SMPC) de Claritromicina
    17) Hipersensibilidad a cualquier principio activo y / o cualquier excipiente de acuerdo con las contraindicaciones reportadas en el SmPC de claritromicina y en el Folleto del investigador (IB) de lenalidomida
    E.5 End points
    E.5.1Primary end point(s)
    Tumor response assessed according to the international Revised Response Criteria for Malignant Lymphoma (Cheson et al) and the GELA (Group d'Etude des Lymphomes de l'Adulte) histological scoring system for post-treatment biopsies of patients with gastric MALT lymphoma. The overall response rate will be represented by the total number of complete and partial responses.
    La respuesta tumoral se evaluó de acuerdo con el Criterio de Respuesta Revisado Internacional para el Linfoma Maligno (Cheson et al) y el sistema de puntuación histológica GELA (GELA) para biopsias postratamiento de pacientes con linfoma MALT gástrico. La tasa de respuesta global estará representada por el número total de respuestas completas y parciales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the whole duration of the study
    Para la entera duración del estudio
    E.5.2Secondary end point(s)
    1) Adverse events incidence, severity and relationship to study treatment
    2) Time from first investigational medicinal product administration to assessment of disease progression or death due to any cause
    3) Time from first investigational medicinal product administration to assessment of disease progression or death due to progression
    4) Time from first IMP administration to patient’s Death
    1) Incidencia de eventos adversos, gravedad y relación con el tratamiento del estudio
    2) Tiempo transcurrido desde la primera administración del medicamento en investigación hasta la evaluación de la progresión de la enfermedad o la muerte por cualquier causa
    3) Tiempo transcurrido desde la primera administración del medicamento en fase experimental hasta la evaluación de la progresión de la enfermedad o la muerte por progresión
    4) Tiempo desde la primera administración IMP hasta la muerte del paciente
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the whole duration of the study
    Para la entera duración del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Italy
    Spain
    Switzerland
    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
    LVLS AFTER 10 YEARS OF FOLLOW-UP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years13
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years13
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.2.1Number of subjects for this age range: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 No
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 68
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NONE
    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 Decision2017-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-27
    P. End of Trial
    P.End of Trial StatusOngoing
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