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    Summary
    EudraCT Number:2006-003750-23
    Sponsor's Protocol Code Number:LINFOTARGAM
    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:2012-03-20
    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 number2006-003750-23
    A.3Full title of the trial
    Treatment With Dense Doses of Chemotherapy Plus Rituximab (R-CHOP/14) and Highly Active Antiretroviral Therapy (HAART) in Patients With Diffuse Large B Cell Lymphoma and Infection With the Human Immunodeficiency Virus (HIV)
    TRATAMIENTO DE PRIMERA LINEA CON QUIMIOTERAPIA A DOSIS DENSAS Y RITUXIMAB (R-CHOP/14) JUNTO A TRATAMIENTO ANTIRETROVIRAL DE GRAN ACTIVIDAD (TARGA) EN PACIENTES CON LIFOMA B DIFUSO DE CELULAS GRANDES (LBDCG) E INFECCIÓN POR EL VIRUS DE LA INMUNODEFICIENCIA HUMANA (VIH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment With Chemotherapy and Antiretroviral Therapy in Patients With Diffuse Large B Cell Lymphoma and Infection With the Human Immunodeficiency Virus (HIV)
    TRATAMIENTO CON QUIMIOTERAPIA JUNTO A TRATAMIENTO ANTIRETROVIRAL EN PACIENTES CON LIFOMA B DIFUSO DE CELULAS GRANDES E INFECCIÓN POR EL VIRUS DE LA INMUNODEFICIENCIA HUMANA (VIH)
    A.4.1Sponsor's protocol code numberLINFOTARGAM
    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 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 supportAMGEN
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCABYC, S.L.
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Somosierra, 12. Portal izqdo. 2ºG
    B.5.3.2Town/ citySan Sebastián de los Reyes (Madrid)
    B.5.3.3Post code28703
    B.5.3.4CountrySpain
    B.5.4Telephone number+34916590433
    B.5.5Fax number+34916548969
    B.5.6E-mailjuan.berges@cabyc.com
    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.2.5The 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 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.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal quimérico producido en células de mamífero en cultivo por cromatografía de afinidad e intercambio iónico.
    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.2.5The 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 nameCiclofosfamida
    D.3.4Pharmaceutical form 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 INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameCiclofosfamida
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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.2.5The 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 nameDoxorrubicina
    D.3.4Pharmaceutical form 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 INNDOXORUBICIN
    D.3.9.1CAS number 23214-92-8
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive namehidroxildaunorrubicina
    D.3.9.4EV Substance CodeSUB06391MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.2.5The 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 nameVincristina
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNVINCRISTINE
    D.3.9.1CAS number 57-22-7
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeSUB00059MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.4
    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.2.5The 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 namePrednisona
    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 INNPREDNISONE
    D.3.9.1CAS number 53-03-2
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive namePrednisona
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Diffuse Large B Cell Lymphoma and HIV Infection
    Linfoma B Difuso de Célula Grande (LBDCG) e infección por el virus de la inmunodeficiencia humana (VIH)
    E.1.1.1Medical condition in easily understood language
    Diffuse Large B Cell Lymphoma and HIV Infection
    Linfoma B Difuso de Célula Grande (LBDCG) e infección por el virus de la inmunodeficiencia humana (VIH)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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 aplicabilidad del tratamiento:
    a) Evaluar la toxicidad del tratamiento según los criterios CTC (versión 3.0) del National Cancer Instute (NCI). (http://ctep.cancer.gov/reporting/ctc_v30.html)
    b) Tasa de infecciones oportunictas y no oportunustas traas 6 ciclos de tratamiento R-CHOP administrados cada 14 días, asociado a TARGA en pacientes con LBDCG e infección por VIH.
    c) Evaluar el cumplimiento terapéutico de los 6 ciclos de tratamiento con R-CHOP por lo que respecta a retrasos en la administracíón de los ciclos y a reducciones de la dosis de quimioterapia (dosis planificada adminsitrada en el plazo previsto).
    E.2.2Secondary objectives of the trial
    1. Evaluar la eficacia del tratamiento en pacientes con LBDCG y VIH:
    a) Determinar la tasa de respuestas globales y remisiones completas tras 6 ciclos de tratamiento con R-CHOP administrados cada 14 días, asociado a TARGA.
    b) Evaluar la duración de la respuesta tras 6 ciclos de tratamiento con R-CHOP administrados cada 14 días, asociado TARGA.
    c) Evaluar la probabilidad de supervivencia libre de evento a los 5 años tras 6 ciclos de tratamiento con R-CHOP administrados cada 14 días, asociado a TARGA.
    d) Evaluar la probabilidad de supervivencia global a los 5 años tras 6 ciclos de tratamiento con R-CHOP administrados cada 14 días, asociados a TARGA.
    2. Identificar los factores predictivos de respuesta tras 6 ciclos de tratamiento con R-CHOP administrados cada 14 días en pacientes con LBDCG e infección por VIH.
    3. Evaluar el impacto de la combinación terapéutica R-CHOP y TARGA en los parámetros de la infección por VIH (carga viral del VIH y recuento de linfocitos CD4+)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes con infección por el VIH (tratados o dispuestos a iniciar tratamiento con TARGA) diagnosticados de LBDGC en cualquier estadio (I-IV según la clasificación de Ann Arbor) no tratados perviamente para el linfoma.
    2. Positividad de los linfocitos B neoplásicos para CD20.
    3. Edad de 18 a 70 años.
    4. Cualquier puntuación del Índice Pronóstico Interbaciona (también aplicable a los LNH en pacientes infectados por el VIH) (ver Apéndice 4).
    5. Puntuación de la escala funcional ECOG de 0 a 3 (ver Apéndice 1).
    6. Consentimiento Informado por escrito.
    7. Recuento absoluto de neutrófilos > 1,5x109/L
    8. Ausencia de neoplasia sincrónica o metacrónica a excepción del carcinoma in situ de cérvix o de cáncer de piel distinto del melanoma.
    9. Recuento de linfocitos CD4+ > o = 100/microlitros.
    E.4Principal exclusion criteria
    1. Pacientes con LBDCG previamente tratado.
    2. Pacientes con linfoma primario del SNC.
    3. Pacientes con LNH de Burkitt o Burkitt-like.
    4. Recuento de linfocitos CD4+ < 100/microlitros.
    5. Infecciones oportunistas u otras neoplasias definitorias de SIDA en actividad.
    6. Drogadicción activa.
    7. Mujeres embarazadas o en periodo de lactancia, o adultos en edad fértil que no tomen un método contraceptivo eficaz.
    8. Pacientes con alteración grave de la función renal (creatinina > 2,5 LSN) o hepática (bilirrubina, ALT o AST > 2,5 LSN), excepto si se sospecha que es debido a la propia enfermedad.
    9. Insuficiencia cardíaca con fracción de eyección < 40%.
    10. Pacientes con enfermedades psiquiátricas graves que puedan interferir con su capacidad para entender el estudio (incluyendo alcoholismo o drogadiccdión activa).
    11. ECOG > 3 (ver Apéndice 1).
    12. Pacientes con hipersensibilidad conocida a las proteínas murinas o a cualquier otro componente de los medicamentos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - To evaluate the applicability of the treatment:
    1. To evaluate the treatment toxicity according to the Common Terminology Criteria (CTC) version 3.0 of the National Cancer Institute (NCI).
    2. To evaluate opportunistic and non-opportunistic infections after 6 cycles of treatment with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) administered every 14 days and highly active antiretroviral therapy (HAART) in patients with diffuse large B cell lymphoma (DLBCL) and HIV infection.
    3. To evaluate the adherence to the treatment with 6 cycles of R-CHOP considering the delays in the administration of the cycles and the reductions in the doses of chemotherapy (planned dose administered in predicted term).
    Evaluación de la aplicabilidad del tratamiento:
    - Variables de seguridad en los ciclos 1 a 6, específicamente: porcentaje de pacientes que presentan neutropenia febril y porcentaje de pacientes que ha presentado alguna infección.
    - Proporción de sujetos que reciben todas las dosis de quimioterapia planificadas en el tiempo previsto.
    - Porporción de ciclos de quimioterapia administrados en las dosis planificadas y en el tiempo previsto.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    Finalización del estudio.
    E.5.2Secondary end point(s)
    To evaluate the efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days (R-CHOP/14):
    1. To determine the global response and complete remission tax.
    2. To evaluate the duration of the response.
    3. To evaluate the probability of event-free survival in 5 years.
    4. To evaluate the probability of global survival in 5 years.
    1. Evaluación de la eficacia:
    - Tasa de respuesta global (remisión completa (RC) y remisión parcial (RP))
    - Tasa de remisión completa (RC)
    - Tasa de remisión completa no documentada/confirmada (RCu)
    - Tasa de respuesta parcial (RP)
    - Tasa de enfermedad estable (EE), progresión (P) y recaída (R)
    - Supervivencia libre de evento (SLE) a los 5 años
    - Supervivencia global (SG) a los 5 años
    2. Factores predictores de respuesta: sexo, edad, estadío, ECOG, LDH, beta-2-microglobulina, enfermedad voluminosa, número de localizaciones nodales, número de localizaciones extranodales.
    3. Análisis de las variables de la carga viral y CD4+ a lo largo del estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    Finalización del estudio.
    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 Yes
    E.6.13.1Other scope of the trial description
    Supervivencia Global (SG), Supervivencia Libre de Enfermedad (SLE) y Factores Predictivos
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number 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 concerned15
    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 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
    El ensayo finalizará prematuramente si tras la inclusión de 25 pacientes la eficacia en términos de remisiones completas resulta ser significativamente inferior a la del grupo control x2. Asimismo, el estudio finalizará si la toxicidad resulta ser significativamente superior. Puesto que la toxicidad será valorada por órganos y grados, se emplearán métodos no paramétricos y se ajustará el nivel de significación para comparaciones múltiples.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 2012-03-20. 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 state50
    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)
    En caso de fracaso terapéutico y subsiguiente salida del presente protocolo, cada centro apliacará el tratamiento que considere más oportuno. Lo mismo es aplicable a las eventuales recaídas del LNH. Se recomiensa, sin embargo, seguir el protocolo del grupo GELTAMO, que contempla quimioterapia de rescate de transplante autogénico de progenitores hematopoyéticos.
    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 Decision2007-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
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