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    Summary
    EudraCT Number:2011-003769-14
    Sponsor's Protocol Code Number:FIL_DLCL10
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-003769-14
    A.3Full title of the trial
    R-CHOP-14 or R-CHOP-21 & consolidation PET–oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low risk profile according to age-adjusted IPI (0 with bulky or 1)
    Studio prospettico multicentrico di Fase II con R-CHOP-14 o R-CHOP-21 e radioterapia di consolidamento PET-oriented
    in pazienti con Linfoma diffuso a grandi cellule B (DLBCL) con IPI=0-1 a profilo clinico sfavorevole
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    R-CHOP-14 or R-CHOP-21 & consolidation PET–oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low risk profile according to age-adjusted IPI (0 with bulky or 1)
    Studio prospettico multicentrico di Fase II con R-CHOP-14 o R-CHOP-21 e radioterapia di consolidamento PET-oriented
    in pazienti con Linfoma diffuso a grandi cellule B (DLBCL) con IPI=0-1 a profilo clinico sfavorevole
    A.4.1Sponsor's protocol code numberFIL_DLCL10
    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 SponsorFondazione Italiana Linfomi ONLUS
    B.1.3.4CountryItaly
    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 supportFondazione Italiana Linfomi ONLUS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Italiana Linfomi ONLUS
    B.5.2Functional name of contact pointSegreteria Scientifica
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezia 16
    B.5.3.2Town/ cityAlessandria
    B.5.3.3Post code15121
    B.5.3.4CountryItaly
    B.5.4Telephone number00390131206288
    B.5.5Fax number00390131203455
    B.5.6E-mailsegreteria@filinf.it
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 MONOHYDRATE
    D.3.9.1CAS number 6055-19-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameCYCLOPHOSPHAMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB16414MIG
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder and solvent 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 INNDOXORUBICIN HYDROCHLORIDE
    D.3.9.1CAS number 25316-40-9
    D.3.9.3Other descriptive nameDOXORUBICIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01827MIG
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 SULFATE
    D.3.9.1CAS number 2068-78-2
    D.3.9.3Other descriptive nameVINCRISTINE SULFATE
    D.3.9.4EV Substance CodeSUB05101MIG
    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 AuthorisationItaly
    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 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.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation 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.3.11 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.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
    Patient with diffuse large B cell lymphoma (DLBCL) with low risk profile according to age-adjusted IPI (0 with bulky or 1)
    Pazienti con Linfoma diffuso a grandi cellule B (DLBCL)con IPI=0-1 a profilo clinico sfavorevole
    E.1.1.1Medical condition in easily understood language
    Patient with diffuse large B cell lymphoma (DLBCL) with low risk profile according to age-adjusted IPI (0 with bulky or 1)
    Patient with diffuse large B cell lymphoma (DLBCL) with low risk profile according to age-adjusted IPI (0 with bulky or 1)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level HLT
    E.1.2Classification code 10012819
    E.1.2Term Diffuse large B-cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate if a chemoimmunotherapy R-CHOP-14 or R-CHOP-21 +/- consolidation RT on positive PET-TC residual mass improves the prognosis in terms of 2years PFS in comparison to an historical population control treated with R-CHOP and RT on bulky disease independently of PET-TC evaluation.
    Valutare se una chemioimmunoterapia R-CHOP-14 o RCHOP-
    21 +/- una radioterapia di consolidamento sulla massa residua PET-TC positiva
    determini un miglioramento della prognosi (PFS a due anni) rispetto ad un confronto
    storico in pazienti trattati con R-CHOP e radioterapia eseguita sulla malattia bulky
    indipendentemente dalla valutazione PET-TC.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of a consolidation RT involved-field on single residual PET-positive area after 6 R-CHOP-14 or R-CHOP-21 cycles in terms of overall response rate (ORR = complete + partial remission: CR +PR) improvement according to standard international response criteria (Cheson 2007);
    To evaluate the ORR after 4 and 6 R-CHOP-14 or R-CHOP-21 cycles; To explore the predictive role of the early PET after 2 R-CHOP-14 or R-CHOP-21 cycles in terms of 2-year PFS (descriptive analysis based on available data).
    Valutare l’efficacia di una radioterapia di consolidamento involved-field sulla sede unica di malattia residua positiva all’esame PET dopo 6 cicli di RCHOP-14 o R-CHOP-21 in termini di miglioramento della risposta clinica (risposta globale = parziale + completa sec criteri di Cheson et al 2007- v. allegato G); Valutare la percentuale di risposte globali dopo i primi 4 cicli e i 6 cicli totali di chemioterapia R-CHOP-14 o R-CHOP-21; Valutare il ruolo predittivo della PET precoce dopo 2 cicli in termini di FFS a due anni (analisi a
    carattere esplorativo sui casi raccolti).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18-80 years
    Patients aged > 70 years with FIT profile according to VGM
    Histological diagnosis of DLBCL (CD20+), follicular lymphoma grade IIIB, T-cell rich large B cell lymphoma
    aaIPI=1 +/- bulky and aaIPI=0 with bulky (>7.5 cm)
    ECOG-PS < 3 unless due to lymphoma
    Ventricular ejection fraction ≥ 50%
    Biochemical, renal and hepatic tests within normal range
    Negative HIV and HBV tests. In case of HBcAb positive and HBsAb +/-, which is indicative of a past infection (occult carriers) the subject can be included, but antiviral prophylaxis with lamivudine must be given from the beginning of treatment until 12 months after treatment completion. Anti-HCV positive patients can be included in the absence of viral replication (HVR-RNA absent or less than 500 copies/ml.
    Written informed consent
    Life-expectancy > 3 months
    Età 18-80 anni;
    Pazienti di età > 70 anni1 con profilo “fit” secondo VGM (vedi appendice M);
    Istologia: Linfoma diffuso a grandi cellule B (CD20+), linfoma follicolare grado IIIB, linfoma a grandi cellule B di tipo T-cell rich;
    Age-adjusted IPI =1+/- bulky e IPI= 0 con bulky (malattia bulky definita come dimensione >7,5 cm in uno dei diametri misurabili);
    PS < 3 se non dovuto al linfoma;
    Frazione di eiezione cardiaca ≥ 50%;
    Normale funzionalità epatica, renale, polmonare;
    Markers virali HIV e HBV negativi;
    Possono essere inclusi pazienti anti-HBc positivi, HBsAg negativi, anti-HBs+/- (portatori occulti) con valori di HBV-DNA inferiori a 2.000 UI/ml, pazienti anti-HCV positivi in assenza di replicazione virale (HCV-RNA assente o inferiore a 500 copie/ml);
    Consenso informato;
    Aspettativa di vita > 3 mesi.
    E.4Principal exclusion criteria
    CD20 negative B-cell lymphoma;
    Lymphoblastic lymphoma or Burkitt’s lymphoma;
    Primary Mediastinal B-cell Lymphoma;
    Grade I, II, IIIa Follicular Lymphoma, Lymphocytic/Lymphoplasmacytic, Marginal, Mantle Lymphoma;
    T cell Lymphoma (any histotype);
    Patients aged > 80 years and < 18 years;
    Age-adjusted IPI= 0 (with no bulky disease);
    PS > 3 if not related to lymphoma;
    Patient already treated with chemotherapy, RT, immunotherapy (with the exception of therapies specified in the study protocol);
    Creatinine >1.4 mg/dl or creatinine clearance <60 ml/min;
    AST/ALT or Bilirubin >2.5 times normal limit, unless the alteration is due to lymphoma;
    Clinically significant cardiopathies or cardiovascular disease (e.g. uncontrolled hypertension, uncontrolled multifocal cardiac arrhythmias);
    Ventricular ejection fraction < 50%;
    Pulmonary pathologies (e.g. BPCO, pulmonary fibrosis, TBC etc);
    Concurrent thrombohemolytic disease;
    HIV positivity;
    Positive serology for HBV (HBsAg+) and HCV positivity in presence of replication marks;
    CNS localization disease;
    Malignancy during last 3 years, except from carcinoma in situ of the cervix, basal cell skin carcinoma or early stage prostate cancer or DCIS (good prognosis) treated only with surgery;
    Inability of the patient to give her/his informed consent;
    Drug addiction or alcoholism;
    Pregnancy or breast-feeding women.

    Linfoma CD20 negativo
    Linfoma linfoblastico, linfoma di tipo Burkitt o linfoma a grandi cellule con aspetti tipo
    Burkitt
    Linfoma a grandi cellule B primitivo del mediastino
    Linfoma di tipo follicolare grado I, II, IIIA, linfocitico/linfoplasmocitico, marginale e
    mantellare.
    Linfoma a cellule T (ogni istotipo)
    DLBCL primitivo cutaneo e osseo.
    DLBCL a esordio extranodale per la quale è in corso protocollo dedicato (es testicolo,
    sistema nervoso centrale)
    Età > 80 e < 18 anni (vedi criteri di inclusione)
    Age-adjusted IPI= 0 in assenza di malattia bulky
    PS > 3 (se non dovuto al linfoma)
    Paziente già trattato con chemioterapia, radioterapia o immunoterapia ad eccezione della
    prefase di terapia specificata nello studio (vedi dopo).
    Insufficienza renale intesa come creatinina >1.4 mg/dl o clearance creatininica <60 ml/min.
    AST/ALT o bilirubina >2.5 volte la norma, a meno che l’alterazione non sia dovuta al
    linfoma.
    Cardiopatia clinicamente significativa: es. ipertensione arteriosa grave non controllata,
    aritmie cardiache multifocali non controllate, cardiopatia ischemica sintomatica o scompenso
    cardiaco congestizio classe NYHA classe III-IV, infarto miocardico acuto pregresso.
    Frazione di eiezione ventricolare < 50% (vedi appendice B).
    Diabete mellito scompensato non controllabile con terapia insulinica.
    Patologia polmonare importante con compromissione della funzionalità (BPCO, fibrosi
    polmonare, TBC etc)
    Malattia tromboembolica concomitante.
    Positività dei markers virali HIV.
    Infezione da epatite B in atto (HBsAg positivi) e HCV positivi con replicazione virale
    Localizzazione di malattia al Sistema Nervoso Centrale (SNC)
    Neoplasia negli ultimi 3 anni, ad eccezione di carcinoma in situ collo utero e basalioma
    cutaneo o carcinoma della prostata in stadio precoce localizzato trattato con exeresi
    chirurgica o brachiterapia con intento curativo, DCIS a buona prognosi mammario trattato
    con sola chirurgia.
    Stato psichico che interferisca con la capacità del paziente di comprendere il programma
    terapeutico e/o di dare il proprio consenso informato.
    Tossicodipendenza o alcolismo
    Gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    PFS, defined as no response after the first 4 cycles or 6 cycles of immunochemotherapy or progression disease after consolidation RT or at any time of therapy, relapse or death from any cause. The PFS includes all patients and its duration is calculated from the date of initiation of therapy to the date of occurrence of any of the events or date of last follow-up, in the absence of such events.
    PFS, definita come non risposta
    dopo i primi 4 cicli o i 6 cicli totali di chemio-immunoterapia o la progressione di
    malattia dopo la radioterapia di consolidamento o in qualunque momento della terapia,
    ricaduta o morte da qualunque causa. La PFS include tutti i pazienti e la sua durata è
    calcolata dalla data dell’inizio della terapia alla data di comparsa di uno degli eventi o
    alla data di ultimo follow-up, in assenza di tali eventi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 anni
    E.5.2Secondary end point(s)
    OS, defining the event as death from any cause. OS includes all patients and the duration is calculated from the initiation of therapy to the date of death or of last follow up.
    Overall Survival (OS), definendo l’evento come la morte da qualunque causa. La OS
    include tutti i pazienti e la sua durata è calcolata dalla data dell’inizio della terapia alla data
    di morte o ultimo follow-up vivo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 years
    4 anni
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned40
    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
    LVLS
    LVLS
    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 months6
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 state112
    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 as follow-up for aggressive large cell lymphoma according to good clinical practise.
    I PAZIENTI SARANNO TRATTATI COME FOLLOW UP DI LINFOMI AGGRESSIVI A GRANDI CELLULE SECONDO QUANTO PREVISTO DALLA PRATICA CLINICA
    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 Decision2012-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
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