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    Summary
    EudraCT Number:2015-003371-29
    Sponsor's Protocol Code Number:FIL_ReRi
    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:2020-11-04
    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 number2015-003371-29
    A.3Full title of the trial
    A combination of Lenalidomide and Rituximab as front line therapy for the treatment of elderly frail patients evaluated in CGA with Diffuse Large B-cells non-Hodgkin Lymphoma.
    A phase II study of the Fondazione Italiana Linfomi (FIL).
    Studio di fase II della Fondazione Italiana Linfomi (FIL) per valutare la combinazione di Lenalidomide e Rituximab in prima linea nei pazienti anziani con linfoma diffuso a grandi cellule B classificati fragili secondo la Valutazione Geriatrica Multidimensionale (CGA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study. A combination of Lenalidomide and Rituximab as front line therapy for elderly frail patients (CGA) with Diffuse Large B-cells non-Hodgkin Lymphoma.
    Studio di fase II per valutare la combinazione di Lenalidomide e Rituximab in prima linea nei pazienti anziani con linfoma diffuso a grandi cellule B classificati fragili (CGA)
    A.3.2Name or abbreviated title of the trial where available
    Not available
    Non disponibile
    A.4.1Sponsor's protocol code numberFIL_ReRi
    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 supportCelgene
    B.4.2CountrySwitzerland
    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 pointUffici Studi FIL
    B.5.3 Address:
    B.5.3.1Street AddressSpalto Marengo 44 c/o Uffici PACTO
    B.5.3.2Town/ cityAlessandria
    B.5.3.3Post code15121
    B.5.3.4CountryItaly
    B.5.4Telephone number00390131033153
    B.5.5Fax number00390131263455
    B.5.6E-mailstartup@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.2.1.1.1Trade name REVLIMID - 5 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CASPULE
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE B.V.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/11/868
    D.3 Description of the IMP
    D.3.1Product nameRevlimid 5 mg
    D.3.2Product code [IMP1]
    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.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeIMP1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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 typeAntineoplastico e immunomodulatore
    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 - 10 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE B.V.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/11/868
    D.3 Description of the IMP
    D.3.1Product nameRevlimid 10 mg
    D.3.2Product code [IMP2]
    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.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeIMP 2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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 typeAntineoplastico e immunomodulatore
    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 - 15 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE B.V.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/11/868
    D.3 Description of the IMP
    D.3.1Product nameRevlimid 15 mg
    D.3.2Product code [IMP3]
    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.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeIMP3
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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 typeAntineoplastico e immunomodulatore
    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 REVLIMID - 20 MG- CAPSULA RIGIDA- USO ORALE- BLISTER (PCTFE/PVC/ALU)- 21 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE B.V.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/11/868
    D.3 Description of the IMP
    D.3.1Product nameRevlimid 20 mg
    D.3.2Product code [IMP4]
    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.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeIMP4
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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 typeAntineoplastico e immunomodulatore
    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-cells non-Hodgkin Lymphoma
    Linfoma diffuso a grandi cellule B
    E.1.1.1Medical condition in easily understood language
    Elderly frail patients with Diffuse Large B-cells non-Hodgkin Lymphoma.
    Pazienti anziani con linfoma diffuso a grandi cellule B classificati fragili
    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 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and the safety of the R2 (Lenalidomide + Rituximab) combination in first line DLBCL patients not candidate for the standard R-CHOP (or R-CHOP like) treatments due to frail status.
    The efficacy will be measured as overall response rate (ORR, defined as complete plus partial remission rate).
    The safety will be measured as rate of the extra-hematologic adverse events of WHO grade 3-4 (NCI CTCAE 4.03)
    Valutare l’efficacia in termini di risposta globale (ORR) della combinazione Lenalidomide e Rituximab (R2) in prima linea in pazienti con DLBCL non candidabili al trattamento standard con R-CHOP (o R-CHOP like) perchè pazienti fragili.
    L’efficacia sarà misurata come tasso di risposta globale (ORR, definito come tasso di risposte complete e parziali).
    La tossicità sarà misurata come incidenza di eventi avversi extra-ematologici di grado 3-4 (NCI CTCAE 4.03)
    E.2.2Secondary objectives of the trial
    Secondary objectives are to better define the R2 efficacy and safety in terms of:
    - Complete Response Rate (CR),
    - Progression-Free Survival (PFS),
    - Overall Survival (OS),
    - Event-Free Survival (EFS),
    - Drop-out rate,
    - Rate of treatment discontinuation due to AE or treatment intolerance,
    - QoL assessement at baseline,4 months, 6 months and 12 months by EORTC-QLQ-C30 and FACT-Lym questionnaire.
    - Hematologic adverse events of any WHO grade (NCI CTCAE 4.03).
    Definire efficacia e tossicità di R2 in termini di:
    - Tasso di risposte complete (CRR),
    - Progression-Free Survival (PFS),
    - Overall Survival (OS),
    - Event-Free Survival (EFS),
    - Tasso di Drop-out,
    - Tasso di interruzioni del trattamento dovute ad eventi avversi o intolleranza al trattamento,
    - Valutazione sulla qualità della vita all’esordio, dopo 4, 6, 12 mesi con i questionari EORTC-QLQ-C30 e FACT-Lym,
    - Incidenza di eventi avversi ematologici di qualsiasi grado (NCI CTCAE 4.03)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenomics
    Version: 2.0
    Date: 26/06/2017
    Title: Pharmacogenomics and pharmacokinetics of Lenalidomide in elderly frail patients evaluated in CGA with Diffuse Large B-cells non-Hodgkin Lymphoma.
    An ancillary study of the FIL_ReRi protocol.

    Objectives: Primary Objective:
    To investigate the pharmacogenomics (PGx) of R2 (Lenalidomide + Rituximab) in first line DLBCL patients not candidate for the standard R-CHOP (or R-CHOP like) treatments due to the frailty.
    Secondary Objectives:
    - To evaluate the PK of R
    - To investigate any possible correlation among pharmacodynamics, pharmacogenomics and pharmacokinetics.


    Life quality
    Version: 2.0
    Date: 26/06/2017
    Title: N/A. This is a secondary objective of the main study
    Objectives: QoL assessement at baseline,4 months, 6 months and 12 months by EORTC-QLQ-C30 and FACT-Lym questionnaire.

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Pharmacogenomics and pharmacokinetics of Lenalidomide in elderly frail patients evaluated in CGA with Diffuse Large B-cells non-Hodgkin Lymphoma.
    An ancillary study of the FIL_ReRi protocol.
    Version n. 2.0 date: June 26th 2017
    Objectives:
    - To evaluate the PK of R
    - To investigate any possible correlation among pharmacodynamics, pharmacogenomics and pharmacokinetics.


    Farmacogenomica
    Versione: 2.0
    Data: 26/06/2017
    Titolo: Valutazione della farmacogenomica e farmacocinetica di Lenalidomide in pazienti anziani con Linfoma Diffuso a Grandi Cellule B classificati fragili secondo la Valutazione Geriatrica Multidimensionale (CGA). Studio ancillare al protocollo FIL_ReRi.
    Obiettivi: Obiettivo Primario:
    Indagare la farmacogenomica (PGx) della combinazione Lenalidomide e Rituximab (R2) in prima linea in pazienti con DLBCL non candidabili al trattamento standard con R-CHOP (o R-CHOP like) perchè pazienti fragili
    Obiettivi secondari:
    - Valutare la farmacocinetica (PK) della Lenalidomide
    - Valutare le possibili correlazioni tra farmacodinamica, farmacogenomica, farmacocinetica



    Qualita' della vita
    Versione: 2.0
    Data: 26/06/2017
    Titolo: N/A.
    Si tratta di uno degli obiettivi secondari dello studio principale

    Obiettivi: Valutazione sulla qualità della vita all’esordio, dopo 4, 6, 12 mesi con i questionari EORTC-QLQ-C30 e FACT-Lym,

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Valutazione della farmacogenomica e farmacocinetica di Lenalidomide in pazienti anziani con Linfoma Diffuso a Grandi Cellule B classificati fragili secondo la Valutazione Geriatrica Multidimensionale (CGA). Studio ancillare al protocollo FIL_ReRi
    Versione 2.0 del 26/06/2017
    Obiettivi:
    - Valutare la farmacocinetica (PK) della Lenalidomide
    - Valutare le possibili correlazioni tra farmacodinamica, farmacogenomica, farmacocinetica
    E.3Principal inclusion criteria
    1. Histologically proven CD20 positive Diffuse Large B-cell Lymphoma, according to WHO classification (local pathologist)
    2. Age = 70 years
    3. Previously untreated
    4. CGA assessment performed before starting treatment
    5. FRAIL patients defined as follows:
    Age >= 80 years (with UNFIT profile):
    ADL >= 5 residual functions and/or
    IADL >= 6 residual functions and/or
    CIRS: 0 comorbidity of grade 3-4 and 5-8 comorbidities of grade 2
    Age < 80 (ONLY one of the following criteria):
    ADL <= 4 residual functions
    IADL <= 5 residual functions
    CIRS: 1 comorbidity of grade 3-4 or > 8 comorbidities of grade 2
    6. Ann Arbor Stage I - IV
    7. At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest dimension on CT scan
    8. ECOG performance status of 0- 3
    9. No active hepatitis C virus (HCV) infection. In case of HCV positivity HCV-RNA is required. Only patients with HCV-RNA negative are accepted.
    10. Adequate hematologic function (unless caused by bone marrow infiltrate), defined as follows:
    - Hemoglobin > 10 g/dL
    - WBC > 2500/mmc with PMN > 1000/ mmc
    - Platelets count = 75000/mmc
    - Creatinine clearance = 10 mL/min
    11. Ability and willingness to comply with the study protocol procedure
    12. Life expectancy > 6 months
    13. Patients must give written informed consent.
    14. Male subjects must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following investigational product discontinuation, even if he has undergone a successful vasectomy.





    1. Conferma istologica di linfoma a grandi cellule B CD20 positivo, secondo la classificazione WHO 2008 (diagnosi del patologo locale)
    2. Età = 70 anni
    3. Pazienti non precedentemente trattati
    4. Valutazione CGA eseguita prima dell’inizio del trattamento
    5. Pazienti FRAIL definiti come segue:
    Età >= 80 anni (con profilo UNFIT):
    ADL >= 5 funzioni residue e/o
    IADL >= 6 funzioni residue e/o
    CIRS: 5-8 comorbidità di grado 2, nessuna di grado 3-4
    Età < 80 (SOLO uno dei seguenti criteri):
    ADL <= 4 funzioni residue
    IADL <= 5 funzioni residue
    CIRS: 1 comorbidità di grado 3-4 o > 8 comorbidità di grado 2
    6. Malattia di stadio I - IV secondo Ann Arbor
    7. Almeno una lesione misurabile in 2 dimensioni perpendicolari con diametro maggiore > 1.5 cm in TAC
    8. ECOG performance status 0- 3
    9. Assenza di infezione attiva da HCV. In caso di HCV positività, è richiesto test HCV-RNA. Solo pazienti con HCV-RNA negativi sono eleggibili.
    10. Normale funzionalità ematologica (se non alterata per infiltrazione midollare) definita come segue:
    - Emoglobina > 10 g/dL
    - Globuli bianchi > 2500/mmc con neutrofili > 1000/ mmc
    - Piastrine = 75000/mmc
    - Clearance della creatinina = 10 mL/min
    11. Capacità e volontà di rispettare le procedure del protocollo
    12. Aspettativa di vita > 6 mesi
    13. Consenso informato scritto del paziente
    14. I pazienti di sesso maschile, anche se resi chirurgicamente sterili (stato di post vasectomia) devono astenersi completamente dai rapporti o utilizzare un efficace contraccettivo di barriera (preservativo) durante rapporti con donne in gravidanza o donne potenzialmente fertili per tutta la durata dello studio, durante le interruzioni di dose e per almeno 28 giorni dalla fine del trattamento.
    E.4Principal exclusion criteria
    1. Histological diagnosis different from CD20 positive Diffuse Large B-cell Lymphoma are excluded.
    2. Previous exposure to cytotoxic agents
    3. Suspect or clinical evidence of CNS involvement by lymphoma
    4. Contraindication to the use of Rituximab or of Lenalidomide
    5. HBsAg positivity; HBsAg-negative patients with anti-HBc antibody can be enrolled if Hepatitis B Virus (HBV)-DNA are negative and antiviral treatment with Lamivudine or Tenofir is provided.
    6. HIV positivity
    7. Active herpes zoster infection; previously infected patients is accepted only with concomitant treatment with Valacyclovir
    8. Any history of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
    9. AST /ALT > 2 x UNL; bilirubin > 2 x UNL; serum creatinine > 2.5 mg /dL
    10. Creatinine clearance < 10 mL/min
    11. Evidence of any severe active acute or chronic infection
    12. Severe cardiac dysfunction (NYHA grade III-IV)
    13. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
    14. Absence of caregivers in non-autonomous patients
    1. Diagnosi istologica diversa da linfoma a grandi cellule B CD20 positivo
    2. Precedente trattamento con agenti citotossici
    3. Sospetto o evidenza clinica di coinvolgimento del SNC da parte del linfoma
    4. Controindicazione all’uso di Rituximab o di Lenalidomide
    5. Pazienti HBsAg positivi; pazienti HBcAb positivi possono essere inclusi solo se l’HBV-DNA è negativo e vengono trattati con Lamivudina o Tenofovir
    6. Pazienti HIV positivi
    7. Pazienti con herpes zoster attivo; possono essere inclusi pazienti che hanno precedentemente avuto l’herpes zoster solo se trattati con Valacyclovir
    8. Pregresse neoplasie solide negli ultimi 5 anni, fatta eccezione per carcinoma basale o squamoso della cute attualmente in remissione o carcinoma in situ della cervice uterina
    9. AST /ALT > 2 x UNL; bilirubina > 2 x UNL; creatinina sierica > 2.5 mg /dL
    10. Clearance della creatinina < 10 mL/min
    11. Evidenza di infezioni gravi acute o croniche
    12. Insufficienza cardiaca severa (NYHA grado III-IV)
    13. Qualsiasi altra condizione medica o psicologica coesistente che precluda la partecipazione allo studio o comprometta la capacità di dare il consenso informato.
    14. Pazienti non autonomi senza una figura che li assista
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: overall response rate (ORR)
    Safety: clinical relevant toxicity, defined as the proportion of patients experiencing a grade 3 or greater non haematological toxicity.
    Efficacia: ORR (tasso di risposta globale)
    Sicurezza: tossicità rilevanti (non ematologiche di grado uguale o maggiore a 3)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy: 48 months
    safety: 48 months
    Efficacia: 48 mesi
    Sicurezza: 48 mesi
    E.5.2Secondary end point(s)
    Complete response rate (CR) ; Haematological toxicity of any WHO grade; Overall Survival (OS); Progression Free Survival (PFS); Event-Free Survival (EFS); Quality of Life (FACT-Lym and EORTC-QLQ-C39)
    Tasso di risposte complete (CR); Tossicità ematologiche di qualsiasi grado; Sopravvivenza globale (OS); Sopravvivenza libera da progressione (PFS); Event-Free Survival (EFS); Qualità della vita (FACT-Lym e EORTC-QLQ-C39)
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 months; 48 months; 60months; 60 months; 60 months; 60 months
    48 mesi; 48 mesi; 60 mesi; 60 mesi; 60 mesi; 60 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans 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.8.2.4Number 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 concerned31
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS that means 12 months after the EoT.
    LVLS ossia 12 mesi dopo la fine del trattamento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months60
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months60
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state68
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    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)
    According to clinical practice
    In accordo alla 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 Decision2016-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
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