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    Summary
    EudraCT Number:2014-001620-29
    Sponsor's Protocol Code Number:R2-GDP-GOTEL
    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:2014-07-22
    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 number2014-001620-29
    A.3Full title of the trial
    Phase II clinical trial to evaluate the combination of lenalidomide with R-GDP (rituximab, gemcitabine, dexamethasone and cisplatin) in patients diagnosed with refractory diffuse large B-cell lymphoma not candidates for high-dose chemotherapy and hematopoietic progenitor cell transplantation
    Ensayo fase II para valorar la combinación de Lenalidomida con R-GDP (R2-GDP) en pacientes con linfoma difuso de células grandes B refractarios o en recaída (R/R LDCGB) no candidatos a quimioterapia a altas dosis y transplante de células progenitoras hematopoyéticas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the treatment with a drug (lenalidomide) with the usually prescribed chemotherapy in patients diagnosed with diffuse large B-cell lymphoma (sort of blood cancer) which did not respond to previous treatments and who can not receive high-dose chemotherapy.
    Ensayo clínico para evaluar el tratamiento con un medicamento (lenalidomida) añadido a la quimioterapia utilizada habitualmente en pacientes con linfoma difuso de células grandes B (cáncer de la sangre) que no han respondido bien a tratamientos previos y que no pueden recibir quimioterapia a altas dosis
    A.4.1Sponsor's protocol code numberR2-GDP-GOTEL
    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 SponsorGrupo Español para el Tratamiento y Estudio de los Linfomas (GOTEL)
    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 supportGrupo Español para el Tratamiento y Estudio de los Linfomas (GOTEL)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Unit & Clinical Trials
    B.5.2Functional name of contact pointClara M. Rosso Fernández
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Manuel Siurot S/N
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955 01 34 14
    B.5.5Fax number0034954 23 29 92
    B.5.6E-mailclaram.rosso.sspa@juntadeandalucia.es
    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 5 mg
    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.3.2Product code NA
    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.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 15
    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 MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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 nameRituximab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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.3.9.4EV Substance CodeSUB12570MIG
    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) 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) Yes
    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.2.1.2Country 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 nameGemcitabine
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNGEMCITABINE
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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.2.1.2Country 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 nameCisplatin
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNCISPLATIN
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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: 5
    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 10 mg
    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.3.2Product code NA
    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.3.9.4EV 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: 6
    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 15 mg
    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.3.2Product code NA
    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.3.9.4EV 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.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
    Refractory Diffuse large B-cell lymphoma.
    Linfoma difuso de células grandes B refractarios.
    E.1.1.1Medical condition in easily understood language
    Sort of cancer (Large B cells lymphoma) from specific haematological cells (from the blood).
    Tipo de cáncer (Linfoma de cálulas B grandes) que afecta a determinadas células hematológicas (de la sangre)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the response rate with the combination of lenalidomide and chemotherapy type R-GDP (Rituximab, Gemcitabine, Dexamethasone and Cisplatin) in patients with relapsed or refractory diffuse large B-cell lymphoma not candidates for high-dose chemotherapy nor transplantation of cells hematopoietic progenitors.
    Determinar la tasa de respuesta obtenida con la combinación de lenalidomida y quimioterapia tipo R-GDP (Rituximab, Gemcitabina, Cisplatino y Dexametasona) en pacientes con linfoma difuso de células grandes B refractarios o en recaída no candidatos a quimioterapia a altas dosis y transplante de células progenitoras hematopoyéticas.
    E.2.2Secondary objectives of the trial
    -Overall survival
    -Progression free survival
    -Safety
    -Biomarker analysis in tumor tissue, associated with the immune response.
    -Genomic analysis of oncogenic mutations
    -Serum immunophenotypic study using flow cytometry
    -Correlate data taken from translational research to clinical data, paying special attention to the subgroup of long-responders
    -Supervivencia Global
    -Supervivencia Libre de Progresión
    -Seguridad
    -Análisis de biomarcadores, en tejido tumoral, relacionados con la repuesta inmune.
    -Estudio Genómico de mutaciones oncogénicas
    -Estudio de inmunofenotipo sérico mediante citometría de flujo.
    -Correlacionar los datos extraídos del estudio traslacional con los datos clínicos, poniendo especial atención al subgrupo de largos respondedores
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients over 18 years old.
    2. Patients with diffuse large cell lymphoma (DLBCL) diagnosed by biopsy, including immunohistochemical positivity for CD20 study.
    3. Patients with relapsed or refractory DLBCL (DLBCL r / r) after receiving at least a first line of treatment that included chemotherapy and anti-CD20 monoclonal antibodies. Biopsy recommended but not mandatory.
    4. Patients who are not candidates for autologous hematopoietic cell transplantation according to the investigator´s criteria.
    5. ECOG Performance Status ? 2.
    6. Life expectancy over 3 months.
    7. All patientsmust accept common contraception methods in clinical trials with lenalidomide.
    8. Women of childbearing potential must have a negative pregnancy test result at screening.
    9. Signed informed consent.
    1. Pacientes con edad igual o mayor a 18 años
    2. Linfoma B difuso de células grandes (LBDCG) diagnosticado mediante biopsia, incluyendo estudio inmunohistoquímico y con demostración de positividad a CD20.
    3. Pacientes con LBDCG refractarios o en recaída (LBDCG r/r) tras haber recibido al menos una primera línea de tratamiento que incluyese quimioterapia y anticuerpos monoclonales anti-CD20. Biopsia de recaída recomendable pero no obligatoria.
    4. Pacientes no candidatos a transplante autólogo de células hematopoyéticas, a criterio del médico responsable.
    5. ECOG Performance Status ? 2.
    6. Expectativa de esperanza de vida superior a 3 meses.
    7. Todos los pacientes incluidos aceptarán las medidas de anticoncepción habituales en los ensayos realizados con lenalidomida.
    8. Las mujeres potencialmente fértiles deberán acreditar un test negativo para embarazo en el momento del screening.
    9. Haber firmado el Consentimiento Informado para inclusión en el estudio.
    E.4Principal exclusion criteria
    1. Patients who may be susceptible of autologous bone marrow transplant during the evolution of the disease according to investigator´s criteria.
    2. Patients with inadequate renal, hepatic or haematological function, and / or showing any of the following laboratory parameters (It is not allowed the use of colony stimulating factors and other similar measures for the inclusion of patients):
    - ANC < 1000 células/mm3
    - Platelets < 75.000/ mm3
    - GOT o GPT > 5 normal level
    - Total bilirubin > 2 mg/dl o conjugated bilirubin > 0.8mg/dl, except if hemolytic anemia.
    - Creatinine clearance < 30 ml/minute
    3. ECOG Performance Status 3 ó 4.
    4. Any other serious medical condition, laboratory abnormality, or psychiatric illness that hinders obtaining informed consent from the patient.
    5. Systemic infection not solved> 2 months before starting experimental treatment despite adequate anti-infective treatment.
    6. Pregnant or lactating women.
    7. Rejection of contraceptive methods according to the protocol.
    8. Patients who had received any experimental therapy within 28 days prior to inclusion in the clinical trial.
    9. Involvement of central nervous system confirmed by cerebrospinal fluid cytology or imaging test.
    10. Previous history of malignant disease unless the patient has been free of disease ? 3 years. The following neoplasia are excluded:
    - Basal cell carcinoma of skin
    - Squamous cell carcinoma of skin
    - Carcinoma in situ of the cervix
    - Carcinoma in situ of breast
    - Incidentally diagnosed prostate carcinoma (T1a or T1b)
    11. Seropositivity for HIV, Hepatitis B or Hepatitis C
    12. Uncontrolled intercurrent illness, such as:
    - Active infection requiring parenteral antibiotics
    - Uncontrolled diabetes mellitus
    - Chronic heart failure (class III or IV NYHA)
    - Unstable angina or angioplasty, stent or heart attack in the last 6 months
    - Thromboembolic disease grade 3-4 in the past 6 months
    - Prior neuropathy grade ? 2
    13. Patients who have received any of the following treatments in the specified period prior day 1:
    - Any chemotherapy in the previous 2 weeks
    - Nitrosoureas in the previous 6 weeks
    - Monoclonal antibodies in previous 8 weeks
    - External radiotherapy in the previous 3 weeks
    - Radioimmunoconjugates in the previous 12 weeks
    1. Pacientes que a criterio de los investigadores puedan ser susceptibles de transplante autólogo de médula ósea en algún momento de la evolución de la enfermedad.
    2. Pacientes con función renal, hepática o hematológica inadecuada, y/o mostrando alguna de los siguientes parámetros de laboratorio (no está permitido el uso de factores estimulantes de colonias ni otras medidas de soporte para la inclusión de los pacientes):
    - ANC < 1000 células/mm3
    - Plaquetas < 75.000/ mm3
    - GOT o GPT > 5 veces el nivel normal
    - Bilirrubina total > 2 mg/dl o bilirrubina conjugada > 0.8mg/dl, excepto si existe anemia hemolítica.
    - Aclaramiento de creatinina < 30 ml/minuto
    3. ECOG Performance Status 3 ó 4.
    4. Alguna otra condición médica grave, anomalía de laboratorio o enfermedad psiquiátrica que dificulte la obtención del consentimiento informado por parte del paciente.
    5. Infección sistémica que no se haya resuelto > 2 meses antes de iniciar el tratamiento de ensayo a pesar de tratamiento anti-infeccioso adecuado.
    6. Mujeres embarazadas o en periodo de lactancia.
    7. Rechazo a utilización de métodos anticonceptivos recomendados según protocolo.
    8. Haber recibido algún tratamiento experimental en los 28 días previos a iniciar el tratamiento de ensayo.
    9. Afectación de sistema nervioso central confirmada por citología de líquido cefalorraquídeo o pruebas de imagen.
    10. Historial previo de enfermedad maligna, salvo que el paciente haya estado libre de enfermedad ? 3 años. Se exceptúan las siguientes neoplasias:
    - Carcinoma basocelular de piel.
    - Carcinoma escamoso de piel.
    - Carcinoma in situ del cervix.
    - Carcinoma in situ de la mama.
    - Carcinoma de próstata diagnosticado incidentalmente (T1a o T1b).
    11. Seropositividad para HIV, hepatitis B o hepatitis C.
    12. Enfermedad intercurrente no controlada, como por ejemplo:
    - Infección activa que requiera antibióticos parenterales.
    - Diabetes mellitus no controlada.
    - Insuficiencia cardiaca crónica sintomática (clase III o IV de la NYHA).
    - Angina de pecho inestable o realización de angioplastia, stent o infarto de miocardio en los últimos 6 meses.
    - Enfermedad tromboembólica grado 3-4 en los últimos 6 meses.
    - Neuropatía previa grado ? 2.
    13. Haber recibido alguno de los siguientes tratamientos en el periodo especificado previo al día 1 del estudio:
    - Cualquier quimioterapia en las 2 semanas previas.
    - Nitrosoureas en las 6 semanas previas.
    - Anticuerpos monoclonales en las 8 semanas previas.
    - Radioterapia externa en las 3 semanas previas.
    - Radioinmunoconjugados en las 12 semanas previas.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate obtained after the period or phase induction obtained with the combination of lenalidomide and immunochemotherapy (R2-GDP) in patients with DLBCL R / R.

    The Overall Response Rate is defined as the addition of the rate of complete response plus partial response rate obtained, according to Cheson criteria 2007.
    Tasa de Respuesta Global obtenida tras el periodo o fase de inducción obtenida con la combinación de lenalidomida e inmunoquimioterapia (R2-GDP) en pacientes con LDCGB R/R.

    La Tasa de Respuesta Global se define como la suma de la tasa de respuestas completas más la tasa de respuestas parciales que se obtengan, según Criterios de Cheson 2007
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the induction phase. 180 days.
    Al final del periodo de inducción. 180 días.
    E.5.2Secondary end point(s)
    - Overall survival: from recruitment or the start of treatment to the date of patient´s death or last date known as the patient was alive.
    - Progression-free survival: from recruitment or the start of treatment to recurrence of disease.
    - Safety: collection and assessment of all adverse events occurring since the signing of informed consent until the last patient visit (SPM last visit at 36 months since the last dose of Lenalidomide).
    - Biomarker analysis in tumor tissue, associated with the immune response.
    - Genomic Study of oncogenic mutations.
    - Serum flow cytometric immunophenotypic studies.
    - Relationship between data taken from translational research and clinical data, paying special attention to the subgroup of long-responders (sustained response over 2 years after receiving the treatment).
    - Supervivencia Global: desde la entrada en el estudio o el inicio del tratamiento hasta la fecha de la muerte del paciente o la última fecha en que se tuvo conocimiento de que el paciente estaba vivo.
    - Supervivencia Libre de Progresión: desde la entrada en el estudio o el inicio del tratamiento hasta la progresión recidiva de la enfermedad.
    - Seguridad: recogida y valoración de todos los acontecimientos adversos que ocurran desde la firma del consentimiento informado hasta la última visita del paciente (última visita SPM a los 36 meses de la última toma de Lenalidomida)
    - Análisis de biomarcadores, en tejido tumoral, relacionados con la repuesta inmune.
    - Estudio Genómico de mutaciones oncogénicas.
    - Estudio de inmunofenotipo sérico mediante citometría de flujo.
    - Correlacionar los datos extraídos del estudio traslacional con los datos clínicos, poniendo especial atención al subgrupo de largos respondedores (respuesta mantenida más de 2 años después de recibir el tratamiento).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until disease progression, unacceptable toxicity or complete response confirmed by PET after 2 years of treatment.
    Hasta progresión de la enfermedad, toxicidad inaceptable o respuesta completa confirmada mediante PET tras 2 años de tratamiento.
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarkers analysis in tumoral tissue
    Análisis de biomarcadores en tejido tumoral
    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 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 No
    E.8.7Trial has a data monitoring committee Yes
    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
    At 36 months of the last dose of Lenalidomide
    A los 36 meses de la última dosis de Lenalidomida
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 77
    F.1.3Elderly (>=65 years) No
    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 state77
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 77
    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)
    Patients will be treated according to the common clinical practice
    Los pacientes serán tratados según la practica clinica habitual
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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