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    Summary
    EudraCT Number:2013-005179-41
    Sponsor's Protocol Code Number:FIL_PTCL13
    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:2014-04-10
    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 number2013-005179-41
    A.3Full title of the trial
    ROMIDEPSIN IN COMBINATION WITH CHOEP AS FIRST LINE TREATMENT BEFORE HEMATOPOIETIC STEM CELL TRANSPLANTATION IN YOUNG PATIENTS WITH NODAL PERIPHERAL T-CELL LYMPHOMAS: A PHASE I-II STUDY.
    ROMIDEPSINA IN COMBINAZIONE CON CHOEP COME TERAPIA DI PRIMA LINEA IN PREPARAZIONE AL TRAPIANTO DI CELLULE STAMINALI EMOPOIETICHE NEI PAZIENTI GIOVANI CON LINFOMA A CELLULE T PERIFERICHE A LOCALIZZAZIONE NODALE: STUDIO DI FASE I-II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ROMIDEPSIN IN COMBINATION WITH CHOEP AS FIRST LINE TREATMENT BEFORE HEMATOPOIETIC STEM CELL TRANSPLANTATION IN YOUNG PATIENTS WITH NODAL PERIPHERAL T-CELL LYMPHOMAS: A PHASE I-II STUDY.
    ROMIDEPSINA IN COMBINAZIONE CON CHOEP COME TERAPIA DI PRIMA LINEA IN PREPARAZIONE AL TRAPIANTO DI CELLULE STAMINALI EMOPOIETICHE NEI PAZIENTI GIOVANI CON LINFOMA A CELLULE T PERIFERICHE A LOCALIZZAZIONE NODALE: STUDIO DI FASE I-II
    A.3.2Name or abbreviated title of the trial where available
    FIL_PTCL13
    FIL_PTCL13
    A.4.1Sponsor's protocol code numberFIL_PTCL13
    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 (FIL-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 Corporation
    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 (FIL-ONLUS)
    B.5.2Functional name of contact pointSegreteria FIL-ONLUS
    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 number+390131206071
    B.5.5Fax number+390131263455
    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.2.1.1.1Trade name ISTODAX
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE CORPORATION
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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/3/05/328 PTCL EU/3/05/279 CTCL
    D.3 Description of the IMP
    D.3.1Product nameRomidepsin
    D.3.2Product code FK228
    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 INNROMIDEPSIN
    D.3.9.1CAS number 128517-07-7
    D.3.9.4EV Substance CodeSUB26362
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 to 5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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 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.3.10 Strength
    D.3.10.3Concentration numberNA
    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 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.3.10 Strength
    D.3.10.3Concentration numberNA
    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 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.3.10 Strength
    D.3.10.3Concentration numberNA
    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 solution 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 INNETOPOSIDE
    D.3.9.1CAS number 33419-42-0
    D.3.9.3Other descriptive nameETOPOSIDE
    D.3.9.4EV Substance CodeSUB07337MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 to 100
    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 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.3.10 Strength
    D.3.10.3Concentration numberNA
    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
    Newly diagnosed patients with Peripheral T-cell lymphomas including: Peripheral T-cell lymphomas not otherwise specified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma (AITL) and ALK– Anaplastic large-cell lymphoma (ALCL).
    Pazienti di nuova diagnosi con linfoma a cellule T periferiche ovvero: Linfoma a Cellule T Non Altrimenti Specificato (PTCL-NOS),
    Linfoma a Cellule T Angioimmunoblastico (AITL)
    Linfoma Anaplastico a Grandi Cellule ALK negativo (ALCL).
    E.1.1.1Medical condition in easily understood language
    Newly diagnosed patients with Peripheral T-cell lymphomas.
    Pazienti di nuova diagnosi con linfoma a cellule T periferiche.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To define the maximum tolerated dose (MTD) of Ro-CHOEP-21 (PHASE I)
    • To evaluate the efficacy in term of Progression Free Survival (PFS) of Ro-CHOEP-21 (PHASE II)
    • Identificazione della Massima Dose Tollerata (MTD) di Ro-CHOEP-21 (FASE I)
    • Valutare l’efficacia di Ro-CHOEP-21 in termini di sopravvivenza libera da malattia (PFS) (FASE II)
    E.2.2Secondary objectives of the trial
    • To assess the feasibility of the Ro-CHOEP-21 treatment strategy combined with SCT (PHASE I)
    • To evaluate ORR and in particular CR rate achieved before and after SCT. (PHASE II)
    • To evaluate event free survival (EFS) and overall survival (OS) (PHASE II)
    • To evaluate the safety of treatment (PHASE II)
    • To evaluate the outcome of early allogeneic SCT in patients in PR at the end of induction phase (PHASE II)
    • To estimate the treatment-related mortality (TRM) (PHASE II)
    • To evaluate the incidence of acute and chronic GVHD in allografted patients (PHASE II)
    • To improve the knowledge on PTCL diagnosis, classification and biology. (PHASE II)
    • Valutare la fattibilità di Ro-CHOEP-21 incorporato in un programma terapeutico comprensivo di SCT. (FASE I)
    · Valutare la percentuale di risposte globali (ORR) ottenute prima e dopo SCT. (FASE II)
    · Valutare la percentuale di risposte complete (CR) ottenute prima e dopo SCT. (FASE II)
    · Valutare la sicurezza del programma terapeutico (FASE II)
    · Valutare la sopravvivenza libera da eventi (EFS) (FASE II)
    · Valutare la sopravvivenza globale (OS) (FASE II)
    · Valutare l’efficacia del trapianto allogenico precoce di cellule staminali emopoietiche (SCT) eseguito in pazienti in risposta parziale (PR) al termine della terapia di induzione (FASE II)
    · Valutare la mortalità correlata al trattamento (TRM) (FASE II)
    · Valutare l’ incidenza di GvHD acuta e cronica nei pazienti sottoposti a trapianto allogenico (FASE II)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. age ≥18 e ≤ 65 years
    2. Peripheral T-cell lymphomas at diagnosis including: PTCL-NOS,
    AITL, ALK–ALCL
    3. Stage II-IV
    4. Written informed consent
    5. No prior treatment for lymphoma
    6. No Central Nervous System (CNS) disease (meningeal and/or brain
    involvement by lymphoma)
    7. HIV negativity
    8. Absence of active hepatitis C virus (HCV) infection
    9. HBV negativity or patients with HBcAb +, HBsAg -, HBs Ab+/-
    with HBV-DNA negativity (in these patients Lamivudine
    prophylaxis is mandatory)
    10. Levels of serum bilirubin, alkaline phosphatase and transaminases <
    2 the upper normal limit, if not disease related
    11. No psychiatric illness that precludes understanding concepts of the
    trial or signing informed consent
    12. Ejection fraction > 50% and myocardial stroke in the last year nor
    QT prolongation (QTc interval < 480 msec using the Fridericia
    formula)
    13. Clearance of creatinine > 60 ml/min if not disease related
    14. Spirometry Diffusion Capacity (DLCO) > 50%
    15. Absence of active, uncontrolled infection
    16. For males and females of child-bearing potential, agreement upon
    the use of effective contraceptive methods prior to study entry, for
    the duration of study participation and in the following 90 days after
    discontinuation of study treatment
    17. Availability of histological material for central review and
    pathobiological studies.
    1. età ≥18 e ≤ 65 anni
    2. nuova diagnosi di PTCL-NOS, AITL, o ALK–ALCL.
    3. stadio II-IV
    4. consenso informato scritto
    5. non aver ricevuto in precedenza trattamenti per il linfoma
    6. no localizzazione SNC della malattia (coinvolgimento meningeo e /
    o coinvolgimento del cervello da parte del linfoma)
    7. sierologia negativa per HIV
    8. assenza di infezione attiva da parte del virus dell’Epatite C (HCV)
    9. assenza di infezione attiva da parte del virus dell’Epatite B (HBV) o
    pazienti con HBcAb +, HBsAg -, HBs Ab + / -, ma con negatività
    HBV-DNA (in questi pazienti la profilassi lamivudina è
    obbligatoria)
    10. livelli di bilirubina sierica, di fosfatasi alcalina e di transaminasi < 2
    volte il limite normale superiore
    11. assenza di alcuna malattia psichiatrica che possa precludere la
    comprensione dei dettagli dello Studio o impedire di firmare il
    consenso informato
    12. frazione di eiezione > 50%, nessun infarto del miocardico
    nell’ultimo anno antecedente l’inizio della terapia e assenza di
    prolungamento dell’intervallo QT (intervallo QT corretto < 480
    msec calcolato con il metodo Fridericia)
    13. clearance della creatinina > 60 ml / min, se non direttamente
    correlata alla malattia
    14. Spirometria per valutazione della capacità di diffusione del CO
    (DLCO) > 50%
    15. assenza di infezioni attive clinicamente significative
    16. per pazienti in età fertile, consenso ad utilizzare metodi di
    contraccezione efficaci prima e durante la partecipazione allo studio
    e nei 90 giorni successive al termine della terapia
    17. disponibilità di materiale istologico per eseguire la revisione
    centralizzata e studi biologici.
    E.4Principal exclusion criteria
    1. age <18 e > 65 years
    2. Hystology other than: PTCL-NOS, AITL, ALK–ALCL
    3. Stage I
    4. Prior treatment for lymphoma
    5. Positive serologic markers for human immunodeficiency virus (HIV)
    6. Active hepatitis B virus (HBV) infection
    7. Active hepatitis C virus (HCV) infection
    8. Serum bilirubin levels > 2 the upper normal limit, if not disease related
    9. Ejection fraction < 50% and no myocardial stroke in the last year nor QT prolongation (QTc interval > 480 msec using the Fridericia formula)
    10. Clearance of creatinine < 60 ml/min if not disease related
    11. DLCO < 50%
    12. Pregnancy or lactation
    13. Patient not agreeing to take adequate contraceptive measures during the study
    14. Psychiatric disease that precludes understanding concepts of the trial or signing informed consent
    15. Any active, uncontrolled infection
    16. Prior history of malignancies other than PTCLs in the last five years (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast).
    1. età < 18 e > 65 anni
    2. Diagnosi istologica diversa da: PTCL-NOS, AITL, ALK-ALCL
    3. Stadio I della malattia
    4. aver ricevuto in precedenza trattamenti per il linfoma
    5. Marcatori sierologici positivi per infezioni da virus
    dell’immunodeficienza acquisita umana (HIV),
    6. Infezione attiva da virus epatite B (HBV)
    7. Infezione attiva da virus epatite C (HCV)
    8. livelli di bilirubina sierica, di fosfatasi alcalina e di transaminasi > 2
    volte il limite normale superiore, se non correlato alla malattia
    9. Frazione d’eiezione < 50% nessun infarto del miocardico
    Sinossi Protocollo FIL_PTCL13 V. 1.0 18/11/2013 Pag. 4 of 12
    nell’ultimo anno antecedente l’inizio della terapia e assenza di
    prolungamento dell’intervallo QT (intervallo QT corretto > 480
    msec calcolato con il metodo Fridericia)
    10. Clearance della creatininina < 60 ml/min se non correlata alla
    malattia
    11. Spirometria per valutazione della capacità di diffusione del CO
    (DLCO) < 50%
    12. Gravidanza o allattamento
    13. Paziente non consenziente ad adottare adeguate misure di
    contraccezione nel periodo della durata dello studio
    14. Patologia psichiatrica che possa precludere la comprensione dei
    dettagli dello Studio o impedire di firmare il consenso informato
    15. Qualunque infezione attiva non controllata
    16. Storia di altra patologia neoplastica nei precedenti 5 anni oltre alla
    diagnosi di PTCL (con l’eccezione del basalioma, carcinoma
    squamocellulare della pelle e del carcinoma in situ della cervice o
    della mammella).
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of dose-limiting toxicity (DLT) of Ro-CHOEP-21, considering as maximum dose the one causing induction of any grade ≥ 3 non hematologic toxicity or a delay >15 days of planned cycle date observed during the first two cycles according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009) (PHASE I)
    • PFS on intention to treatment (ITT) evaluated at 18 months. PFS will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause. (PHASE II)
    • Incidenza della tossicità della dose limitante (DLT) di Ro-CHOEP-21, considerando come dose massima tollerata quella causante qualunque grado ≥ 3 di tossicità non ematologica o un ritardo > 15 giorni dell’inizio del ciclo terapeutico programmato, nel corso dei primi due cicli di terapia in accordo con i criteri definiti dal NCI Common Terminology Criteria for Adverse Events (CTCAE), versione 4.0 (2009) (FASE I)
    • Valutazione a 18 mesi della sopravvivenza libera da progressione (PFS) basata sulla intenzione di trattamento (ITT). La PFS sarà definita come il tempo intercorso fra la data di arruolamento e la data di progressione, ricaduta, o morte per qualsiasi causa. (FASE II)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: 3 months
    Phase II: 18 months
    FASE I: 3 mesi
    FASE II: 18 mesi
    E.5.2Secondary end point(s)
    • Proportion of patients reaching SCT (PHASE I)
    • Overall response rate (ORR, defined according to the Cheson 2007 response criteria) of the combination of Ro-CHOEP-21. (PHASE I)
    • ORR and CR (defined according to the Cheson 2007 response criteria), after Ro-CHOEP-21 and after SCT Event free survival (EFS) induction treatment and after SCT (PHASE II)
    • Event free survival (EFS) defined as the time between the date of enrollment and the date of discontinuation of treatment for any reason (PHASE II)
    • Overall survival (OS) defined as the time between the date of enrolment and the date of death from any cause in the ITT population enrolled in the study (PHASE II)
    • PFS and OS in patients not responding to the first 3 courses of Ro-CHOEP-21 (PHASE II)
    • Evaluation during the interim analyses of any grade III or higher toxicities, recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009) (PHASE II)
    • Evaluation during all the pretransplant phase of any grade III or higher toxicities, recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009) (PHASE II)
    • Any grade III or higher toxicities, recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009) (PHASE II)
    • Treatment-related mortality defined as any death that was not attributable to the lymphoma. (PHASE II)
    • Incidence of acute and chronic GVHD in allografted patients (PHASE II)
    FASE I:
    · Proporzione di pazienti che eseguono il trapianto (SCT)
    · Proporzione di risposte globali (ORR) definite secondo i criteri di Cheson 2007.
    FASE II:
    · Proporzione di risposte globali (ORR), definite come Risposte Complete (CR) e
    Risposte Parziali (PR), definite secondo i criteri di Cheson 2007.
    · Proporzione di Risposte Complete (CR), definite secondo i criteri di Cheson
    2007.
    · Sopravvivenza libera da eventi (EFS) definita come il tempo intercorso fra la
    data di arruolamento e la data di interruzione del trattamento per qualsiasi
    causa.
    · Sopravvivenza globale (OS) definita come il tempo intercorso fra la data di
    arruolamento e la data di decesso per qualsiasi causa basata sulla popolazione
    ITT.
    · Tossicità di grado 3 o superiore, registrata e definite secondo NCI Common
    Terminology Criteria for Adverse Events (CTCAE), versione 4.0 (2009)
    · Mortalità trattamento correlata (TRM), definita come qualsiasi decesso non
    attribuibile al linfoma
    · Incidenza di GVHD acuta e cronica nei pazienti trapiantati
    E.5.2.1Timepoint(s) of evaluation of this end point
    • rate of patients who undergo transplantation (SCT): 6 months
    • rate of overall response rate (ORR): 6 months
    • rate of complete responses (CR): 6 months
    • Event Free Survival (EFS): 18 months
    • Overall survival (OS): 24 months
    • Toxicity: 18 months
    • Treatment-related mortality (TRM): 24 months
    • Incidence of acute and chronic GVHD in transplant patients: 24 months
    Proporzione di pazienti che eseguono il trapianto (SCT): 6 mesi
    · Proporzione di risposte globali (ORR): 6 mesi
    · Proporzione di risposte complete (CR): 6 mesi
    · Sopravvivenza libera da eventi (EFS): 18 mesi
    · Sopravvivenza globale (OS): 24 mesi
    · Tossicità: 18 mesi
    · Mortalità trattamento correlata (TRM): 24 mesi
    · Incidenza di GVHD acuta e cronica nei pazienti trapiantati: 24 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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose finding study
    Studio di dose finding
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other 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 concerned30
    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 years8
    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: 110
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state122
    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 followed for 8 years from the enrollment. There are no specific programs at the end of this period.
    I pazienti saranno seguiti per 8 anni dall’ingresso nello studio. Non sono previsti programmi specifici al termine di questo periodo.
    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 Decision2014-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-27
    P. End of Trial
    P.End of Trial StatusOngoing
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