Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36603   clinical trials with a EudraCT protocol, of which   6045   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-000924-16
    Sponsor's Protocol Code Number:FIL_Veral12
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-10-25
    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 number2012-000924-16
    A.3Full title of the trial
    Phase II randomized study with R-DHAP +/- Bortezomib as induction therapy in relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) patients before High-Dose chemotherapy BEAM with autologous stem cell transplantation (ASCT). BR-DHAP + BEAM + ASCT versus R-DHAP + BEAM + ASCT.
    Studio di fase 2 con RDHAP +/- bortezomib nella terapia di induzione pre-consolidamento ad alte dosi e trapianto autologo di cellule staminali in linfomi diffusi a grandi cellule B recidivati-refrattari : BR-DHAP + ASCT versus R-DHAP + ASCT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II randomized study with R-DHAP +/- Bortezomib as induction therapy in relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) patients before High-Dose chemotherapy BEAM with autologous stem cell transplantation (ASCT). BR-DHAP + BEAM + ASCT versus R-DHAP + BEAM + ASCT.
    Studio di fase 2 con RDHAP +/- bortezomib nella terapia di induzione pre-consolidamento ad alte dosi e trapianto autologo di cellule staminali in linfomi diffusi a grandi cellule B recidivati-refrattari : BR-DHAP + ASCT versus R-DHAP + ASCT
    A.3.2Name or abbreviated title of the trial where available
    FIL_Veral12
    FIL_Veral12
    A.4.1Sponsor's protocol code numberFIL_Veral12
    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 supportJanssen
    B.4.2CountryUnited States
    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 number0131206261
    B.5.5Fax number0131263455
    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 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.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 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.3.9.1CAS number 15663-27-1
    D.3.9.4EV Substance CodeSUB07483MIG
    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 Powder and solvent 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 INNCYTARABINE
    D.3.9.1CAS number 147-94-4
    D.3.9.4EV Substance CodeSUB06880MIG
    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 Concentrate 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 INNDEXAMETHASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.4EV Substance CodeSUB07017MIG
    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 Powder and solvent 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 INNETOPOSIDE
    D.3.9.1CAS number 33419-42-0
    D.3.9.4EV Substance CodeSUB07337MIG
    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.2.1.2Country 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 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 INNMELPHALAN
    D.3.9.1CAS number 148-82-3
    D.3.9.4EV Substance CodeSUB08728MIG
    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: 7
    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 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 INNFOTEMUSTINE
    D.3.9.1CAS number 92118-27-9
    D.3.9.4EV Substance CodeSUB07809MIG
    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: 8
    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 INNPEGFILGRASTIM
    D.3.9.1CAS number 208265-92-3
    D.3.9.4EV Substance CodeSUB16451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Yes
    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: 9
    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 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 INNBORTEZOMIB
    D.3.9.1CAS number 179324-69-7
    D.3.9.4EV Substance CodeSUB20020
    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
    Younger Patients (18-65 years) with DLBCL who have failed or have relapsed and are eligible to high-dose therapy will be enrolled.
    Pazienti giovani (18-65 anni) affetti da DLBCL recidivati/refrattari, eligibili a terapia ad alte dosi.
    E.1.1.1Medical condition in easily understood language
    Younger Patients (18-65 years) with DLBCL who have failed or have relapsed and are eligible to high-dose therapy will be enrolled.
    Pazienti giovani (18-65 anni) affetti da DLBCL recidivati/refrattari, eligibili a terapia ad alte dosi.
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10012821
    E.1.2Term Diffuse large B-cell lymphoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    Primary objective is to assess whether the experimental treatment achieves an absolute increase of the CR proportion of at least 20% (from 30% to 50%) with respect to the standard treatment.
    Lo scopo dello studio è di valutare se l’aggiunta di bortezomib al RDHAP sia più attivo rispetto a R-DHAP nella fase di induzione pre-consolidamento ad alte dosi con ASCT in termini di risposta e di sicurezza.
    E.2.2Secondary objectives of the trial
    • Overall Response Rate (ORR) prior to consolidation • Progression free survival (PFS) • Overall Survival (OS) • Feasibility and toxicity • The mobilizing potential • The rate of patients actually proceeding to ASCT.
    • Incidenza di risposte globali (ORR) • Sopravvivenza libera da progressione (PFS) • Sopravvivenza globale (OS) • Tossicità • Capacità mobilizzante • Fattibilità
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    FIL_VERAL12 V. 1 20 /08/2012 Immunohistochemical and molecular studies, with the aim of better understanding of the nature and the biological and molecular features of this disease.

    ALTRI SOTTOSTUDI:
    FIL_VERAL12 V. 1 20 /08/2012 Studi molecolari e di immuno-istochimica con l'obiettivo di comprendere meglio la natura e le caratteristiche biologiche e molecolari della patologia.

    E.3Principal inclusion criteria
    1. Age 18-65 2. Relapsed/refractory disease after receiving one line of standard R-CHOP like chemotherapy 3. Diffuse Large B-cell Lymphoma at relapse. Patient has to be re-biopsied prior to study entry. If this is harmful for the patient, the patient can be enrolled if archivial tumor sample and block from first diagnosis are available. 4. No prior Bortezomib therapy 5. Measurable and/or evaluable disease 6. Any Ann Arbor stage and IPI group at relapse 7. Performance status < 2 according to ECOG scale unless due to lymphoma 8. No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma) 9. Adequate haematological counts: ANC > 1.5 x 109/L, Hgb > 10.5 g/dl (transfusion independent), Platelet count > 75 x 109/L (transfusion independent), with the exception of cytopenia due to lymphoma bone marrow involvement 10. HIV negativity, HCV negativity, HBV negativity or patients with HBcAb +, HBsAg -, HBs Ab+/- with HBV-DNA negativity (in these patients Lamivudine prophylaxis is mandatory) 11. Normal liver function (ALP, AST, ALT, GGT, conjugated bilirubin total < 2 x ULN) if not related to lymphoma 12. Normal kidney function (creatinine clearance > 45 ml/min) 13. Cardiac ejection fraction > 50% (MUGA scan or echocardiography) 14. Normal lung function 15. Absence of active opportunistic infections 16. Non peripheral neuropathy or active neurological non neoplastic disease of CNS 17. Non major surgical intervention prior 3 months to randomization if not due to lymphoma and/or no other disease life-threatening that can compromise chemotherapy treatment 18. Disease free of prior malignancies other than lymphoma for > 3 years with exception of currently treated squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast 19. Life expectancy > 6 months 20. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent 21. Written informed consent 22. Women must be: - postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months) - surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), - abstinent (at the discretion of the investigator/per local regulations), or - if sexually active, be practicing a highly effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study. They must also be prepared to continue birth control measures for at least 12 months after terminating treatment. 23. Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening 24. Men must agree to use an acceptable method of contraception (for themselves or female partners as listed above) for the duration of the study. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.
    Criteri di inclusione 1. Età 18-65 2. Malattia refrattaria/recidivata dopo una linea di terapia RCHOP o simili 3. DLCL alla recidiva . I pazienti devono essere ri-sottoposti a biopsia prima dell’arruolamento. Se l’approccio bioptico comporta un rischio per il paziente, è consentito procedere all’arruolamento solo se disponibile in archivio materiale bioptico sottoforma di blocchetto concernente la diagnosi iniziale 4. Non precedente terapia con bortezomib 5. Malattia misurabile o valutabile 6. Qualsiasi stadio secondo Ann Arbor o gruppo prognostico secondo IPI 7. Performance status &lt; 2 secondo la scala ECOG, salvo se correlate al linfoma 8. Assenza di localizzazioni al Sistema nervoso Centrale (meningee o parenchimali) 9. Adeguata crasi ematica : neutrofili &gt; 1.5 x 109/L, Hgb &gt; 10.5 g/dl (non dipendente da trasfusione), Piastrine &gt; 75 x 109/L (non dipendente da trasfusione), con l’eccezione delle citopenie conseguenti a infiltrazione midollare da parte del linfoma 10. Marcatori virali negativi: HIV, HCV , HBV con l’eccezione dei pazienti “portatori occulti” con HBcAb +, HBsAg -, HBs Ab+/-, HBV-DNA negativo, per i quali è obbligatoria la profilassi con lamivudina 11. Normale funzionalità epatica (ALP, AST, ALT, GGT, bilirubina totale &lt; 2 x ULN) a meno che non sia correlabile a infiltrazione da linfoma 12. Normale funzionalità renale (creatinine clearance &gt; 45 ml/min) 13. Frazione di eiezione cardiaca ventricolare &gt; 50, misurata tramite MUGA scan o ecocardiogramma 14. Normale funzionalità polmonare 15. Assenza di infezioni opportunistiche in corso 16. Assenza di neuropatia periferica o di patologia neurologica non neoplastica in fase attiva 17. Non chirurgia maggiore nei 3 mesi precedenti la randomizzazione a meno che non si tratti di chirurgia correlate al linfoma e/o nessuna patologia a rischio di vita che possa compromettere l’esecuzione del trattamento chemioterapico 18. Assenza di altre patologie maligne diverse dal linfoma nei 3 anni precedenti con l’eccezione del carcinoma spino e basocellulare della cute o del carcinoma in situ della cervice uterina o della mammella, adeguatamente trattati 19. Aspettativa di vita &gt; 6 mesi 20. Assenza di patologia psichiatrica che precluda la comprensione dei concetti principali del protocollo o la firma del consenso informato 21. Consenso informato scritto 22. Le pazienti di sesso femminile devono : - Essere in post menopausa da almeno un anno (= non ciclo mestruale naturale da almeno 12 mesi) oppure - Essere chirurgicamente sterili (sottoposte a isterectomia o ovariectomia bilaterale, legatura della tube, o non adatte alla gravidanza per altre ragioni ) - Se sessualmente attive , devono utilizzare un metodo altamente efficace di controllo delle nascite quali: contraccettivi orali o per iniezione o per via percutanea, dispositivi intrauterini (IUD), doppio metodo di barriera (profilattico, diaframma o cuffia cervicale, con schiuma, gel o crema spermicida, o sterilizzazione del partner maschile) come consentito dalle autorità regolatorie, ed essere d’accordo a utilizzare lo stesso metodo contraccettivo per tutta la durata dello studio . Devono anche essere edotte a utilizzare un metodo per il controllo delle nascite per almeno 12 mesi dopo il temine del trattamento. 23 Per le pazienti donne in età fertile: test di gravidanza sierico o urinario (beta-gonadotropina corionica umana ) negativo al momento dello screening 24 I pazienti di sesso maschile devono acconsentire a utilizzare un metodo contraccettivo accettabile (per se e per la partner come elencato come sopra elencato) per tutta la durata dello studio. I pazienti maschi devono utilizzare un doppio metodo di barriera per il controllo delle nascite a non donare lo sperma per almeno e mesi dopo l’ultima dose di farmaci nell’ambito dello studio
    E.4Principal exclusion criteria
    1. Diagnosis of Lymphoblastic Lymphoma, Burkitt Lymphoma, Non Hodgkin Lymphoma CD20 negative, Mantle Cell Lymphoma, Follicular Lymphoma g I-II-IIIa-IIIb, Primary Mediastinal Lymphoma 2. Age > 65 years 3. Patients ineligible to high-dose chemotherapy 4. Performance status > 2 according to ECOG scale if not due to lymphoma 5. Patient has known or suspected hypersensitivity or intolerance to Rituximab 6. Patient has received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. 7. CNS disease (meningeal and/or brain involvement by lymphoma) 8. History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances 9. Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug 10. Uncontrolled or severe cardiovascular disease including myocardial infarction within six months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 11. Cardiac ejection fraction < 45% (MUGA scan or echocardiography) 12. Creatinine clearance < 45 ml/min 13. Presence of major neurological disorders 14. HIV positivity, HCV positivity, HBV positivity with the exception of patients with HBcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative 15. Active opportunistic infection 16. Major surgical intervention prior 3 months to randomization if not due to lymphoma and/or other disease life-threatening that can compromise chemotherapy treatment 17. Prior malignancies other than lymphoma in the last 3 years with exception of currently treated squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast 18. Life expectancy < 6 months 19. Any other coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent. 20. If female, the patient is pregnant or breast-feeding.
    1. Diagnosi di linfoma linfoblastico, linfoma di Burkitt, linfoma Non Hodgkin CD20 negativo, linfoma mantellare, linfoma follicolare , linfoma primitive del mediastino 2. Età &gt; 65 anni 3. Ineligibilità alla chemioterapia ad alte dosi 4. Performance status &gt; 2 in base alla scala ECOG se non correlabile al linfoma 5. Nota o sospetta ipersensibilità o intolleranza al Rituximab 6. Trattamento con farmaco o dispositivo sperimentale nelle 4 settimane precedenti alla prevista data di inizio del trattamento E’ consentita la partecipazione in altri protocolli non farmacologici, purchè non interferiscano con la partecipazione in questo studio 7. Localizzazione di malattia al SNC (meningi o parenchima cerebrale) 8. Anamnesi pregressa di patologie epatiche, renali, cardiache , vascolari, polmonari, gastrointestinali, endocrine, neurologiche, reumatologiche, ematologiche, psichiatriche, o metaboliche clinicamente rilevanti . 9. Diabete mellito non controllato (se il paziente è in trattamento con farmaci antidiabetici, la dose di essi deve essere stata stabile per almeno i mesi precedenti) 10. Patologia cardiovascolare non controllata o severa , includendo: infarto miocardico nei sei mesi precedenti l’arruolamento, scompenso cardiaco do classe III o IV della New York Heart Association (NYHA) angina non controllata, patologia pericardica clinicamente significativa , amiloidosi cardiaca . 11. Frazione di eiezione ventricolare &lt; 45% (in base a MUGA o ecocardiogramma ) 12. Creatinina clearance &lt; 45 ml/min 13. Presenza di patologie neurologiche maggiori 14. Positvità di HIV , HCV , HBV fatta eccezione per i pazienti con HBcAb +, HbsAg -, HBs Ab+/- purchè con HBV-DNA negativo 15. Infezione opportunistica attiva 16. Intervento chirurgico maggiore nei tre mesi precedenti la randomizzazione se non correlate al linfoma e/o ad altre patologie a rischio di vita che potrebbero compromettere il trattamento chemioterapico 17. Precedente patologia tumorale differente dal linfoma nei tre anni precedenti, col l’eccezione del carcinoma squamo o basocellulare della cute o del carcinoma in situ della cervice uterine o della mammella adeguatamente trattati 18. Life expectancy &lt; 6 months 19. Qualsiasi altra patologia medica o psicologica che potrebbe precludere la partecipazione allo studio o compromettere la capacità di fornire il consenso informato 20. Paziente di sesso femminile in stato di gravidanza o in corso di allattamento al seno
    E.5 End points
    E.5.1Primary end point(s)
    The complete response rate (CR) evaluated by PET scan after four cycles of R-DHAP ± Bortezomib before ASCT according to Cheson criteria
    Il tasso di risposta completa (CR), valutati da PET scan dopo quattro cicli di R-DHAP ± Bortezomib prima ASCT in base a criteri Cheson
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    • Overall response rate (ORR): a patient is defined as a responder if he has a complete or partial response, evaluated by PET/TC, after four cycles of R-DHAP ± Bortezomib • Progression free survival (PFS): measured from the date of randomization to the date of disease progression, relapse or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last assessment date. • OS: measured from the date of randomization to the date of death from any cause. Patients alive at the time of the final analysis will be censored at the date of the last contact. For both PFS and OS minimum follow up time required for all patients will be 2 years. • Toxicity: severe, life- threatening, fatal (grade 3, 4 and 5) and/or serious adverse events are defined according to “Common Terminology Criteria for Adverse Events” (CTCAE), version 4.0. • Mobilizing potential: amount of CD34 + stem cell collected /Kg • Feasibility: proportion of randomized patients successfully completing ASCT
    • Incidenza di risposte globali (ORR) : si definisce un paziente in risposta se si rileva un risposta parziale o completa, valutata tramite PET /TAc dopo 4 cicli di R-DHAP ± Bortezomib • Sopravvivenza libera da progressione (PFS): calcolata dalla data di randomizzazione alla data di progressione di malattia o della recidiva o del decesso da qualsiasi causa. I pazienti in risposta e i pazienti persi al follow up verranno censorizzati alla data dell’ultima valutazione. • Sopravvivenza globale (OS): calcolata dalla data della randomizzazione alla data del decesso da qualsiasi causa . I pazienti vivi alla data dell’analisi finale verranno censorizzati alla data dell’ultimo contatto. Tanto per il calcolo PFS quanto per OS il minimo follow up richiesto è di due anni • Tossicità: severa, a rischio di vita, fatale (grado 2,4,5) e/o eventi avversi seri definiti secondo la versione 4.0 della scala “Common Terminology Criteria for Adverse Events” (CTCAE) • Capacità mobilizzante : numero di cellule CD34+/kg raccolte • Fattibilità: percentuale di pazienti randomizzati che realmente completano il programma di consolidamento ad alte dosi/ASCT
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 month - 7 years
    6 mesi - 7 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 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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned45
    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 years0
    E.8.9.1In the Member State concerned months66
    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.1.1Number of subjects for this age range: 0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state108
    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)
    At the end of participation in the study, the patients will be followed as required by standard practice.
    Al termine della partecipazione allo studio i pazienti verranno seguiti secondo quanto previsto dalla comune 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 Decision2012-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA