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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2012-001580-68
    Sponsor's Protocol Code Number:RoCHOP
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-07
    Trial results View 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 ConcernedPortugal - INFARMED
    A.2EudraCT number2012-001580-68
    A.3Full title of the trial
    Phase 3 Multi-Center Randomized Study to Compare Efficacy and Safety of Romidepsin-CHOP (Ro-CHOP) versus CHOP in patients with Previously Untreated Peripheral T-Cell Lymphoma.
    Estudo de fase 3, multicêntrico e aleatorizado, para comparar a eficácia e segurança da Romidepsina associada a CHOP (Ro-CHOP) com a do CHOP em doentes com linfoma T periférico não previamente tratados.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi-Center Randomized Study to Compare Efficacy and Safety of Romidepsin with CHOP (Ro-CHOP) versus CHOP in subjects with Previously Untreated Peripheral T-Cell Lymphoma.
    Estudo multicêntrico e aleatorizado, para comparar a eficácia e segurança da Romidepsina associada a CHOP (Ro-CHOP) com a do CHOP em doentes com linfoma T periférico não previamente tratados.
    A.3.2Name or abbreviated title of the trial where available
    RoCHOP
    A.4.1Sponsor's protocol code numberRoCHOP
    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 SponsorLYSARC
    B.1.3.4CountryFrance
    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 organisationValesta Consulting, S.L.
    B.5.2Functional name of contact pointJavier Rodriguez Hernandez
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 583 - Planta 5ª
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08011
    B.5.3.4CountrySpain
    B.5.4Telephone number+34654 39 06 70
    B.5.5Fax number+34918 05 11 69
    B.5.6E-mailjavier.rodriguez@valesta.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade 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
    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
    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 AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCYCLOPHOSPHAMIDE
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDOXORUBICIN
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICIN
    D.3.9.1CAS number 23214-92-8
    D.3.9.4EV Substance CodeSUB06391MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePREDNISONE
    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.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVINCRISTINE
    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
    D.3.9.1CAS number 57-22-7
    D.3.9.4EV Substance CodeSUB00059MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 RoleComparator
    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 AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCYCLOPHOSPHAMIDE
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 RoleComparator
    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 AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDOXORUBICIN
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICIN
    D.3.9.1CAS number 23214-92-8
    D.3.9.4EV Substance CodeSUB06391MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 RoleComparator
    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 AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePREDNISONE
    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.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 9
    D.1.2 and D.1.3IMP RoleComparator
    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 AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVINCRISTINE
    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
    D.3.9.1CAS number 57-22-7
    D.3.9.4EV Substance CodeSUB00059MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Peripheral T-Cell Lymphoma
    Linfoma T periférico
    E.1.1.1Medical condition in easily understood language
    Lymphoma
    Linfoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10034623
    E.1.2Term Peripheral T-cell lymphoma unspecified
    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
    The primary objective of the study is to compare efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL)
    O objetivo primário do estudo é comparar a eficácia da Romidepsina quando se administra com CHOP frente a CHOP só em doentes com linfoma T periférico não tratado previamente (PTCL) no que se refere a sobrevivência livre de progressão (SLP) avaliada de acordo com os Response criteria for malignant lymphoma 1999 (Critérios de resposta para o linfoma maligno 1999) do Response Adjudication Committee (Comitê de avaliação de resposta) (RAC).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare Ro-CHOP and CHOP alone in terms of:
    • Overall survival
    • Overall Response Rate (ORR [PR+CR+CRu]) (according to the Response criteria for malignant lymphoma 1999)
    • Duration of response
    • Time to progression
    • Time to treatment failure
    • Safety
    • Quality of Life (QoL)
    • Response rates by PTCL histological subtypes
    • Response rate by standard prognostic parameters
    Os objetivos secundários são comparar Ro-CHOP frente a CHOP só no que se refere a:
    • Sobrevivência global
    • Taxa de resposta global (TRG [RP+RC+RCnc]) (de acordo com os Response criteria for malignant lymphoma 1999)
    • Duração da resposta
    • Tempo até a progressão
    • Tempo até o fracasso do tratamento
    • Segurança
    • Qualidade de vida (QoL)
    • Taxas de resposta por subtipos histológicos de PTCL
    • Taxa de resposta por parâmetros de prognóstico convencionais
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must satisfy all following criteria to be enrolled in the study:
    1. Males and females of 18 years of age to 80 years of age.
    2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
    3. Able to adhere to the study visit schedule and other protocol requirements.
    4. Patients with histologically proven peripheral T-cell lymphoma (PTCL), not previously treated; the following subtypes as defined by the WHO classification (2008;2011) may be included, whatever the Ann Arbor stage (l-lV):
    a. Nodal types:
    i. PTCL, not otherwise specified
    ii. Angioimmunoblastic T-cell lymphoma
    iii. Anaplastic large cell lymphoma, ALK-negative type

    b. Extra-nodal types:
    i. Enteropathy-associated T-cell lymphoma
    ii. Hepato-splenic T-cell lymphoma
    iii. Subcutaneous panniculitis-like T-cell lymphoma
    iv. Primary cutaneous gamma-delta T-cell lymphoma
    v.Primary cutaneous CD8+ aggresive epidermotropic lymphoma
    vi. Primary cutaneous CD4+ small/medium T-cell lymphoma

    c. Other non classifiable peripheral T-cell lymphoma

    5. ECOG performance status 0, 1 or 2
    6. Negative pregnancy test for females of childbearing potential (FCBP)
    7. Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter.
    8. Life expectancy of ≥ 90 days (3 months).
    1. Homens e mulheres de 18 anos de idade a 80 anos de idade.
    2. Compreender e assinar voluntariamente um documento de consentimento informado antes de realizar qualquer avaliação/procedimento relacionado com o estudo.
    3. Poder cumprir com o calendário de visitas do estudo e outros requisitos do protocolo.
    4. Doentes com linfoma T periférico (PTCL) demonstrado histologicamente, não tratado previamente; podem incluir-se os seguintes subtipos tal como os define a classificação da OMS (2008; 2011), qualquer que seja o estádio Ann Arbor (I - IV):
    a. Tipos ganglionares:
    i. PTCL, não especificado de outro modo
    ii. Linfoma angioimunoblástico de células T
    iii. Linfoma anaplásico de células grandes, de tipo negativo para ALK
    b. Tipos extraganglionares:
    i. Linfoma T associado com enteropatia
    ii. Linfoma hepatoesplênico de células T
    iii. Linfoma T de tipo paniculite subcutânea
    iv. Linfoma cutâneo primário de células T gama-delta
    v. Linfoma cutâneo primário agressivo epidermotrópico de células CD8+
    vi. Linfoma cutâneo primário de células T CD4+ pequenas/médias
    c. outros linfomas T periféricos não classificáveis
    5. Estado geral de acordo com ECOG 0, 1 ou 2
    6. Teste de gravidez negativo para mulheres em idade de procriar (FCBP)
    7. As mulheres em idade de procriar devem utilizar um método eficaz de controlo de natalidade (isto é, anticoncetivo hormonal, dispositivo intrauterino, diafragma com espermicida, preservativo com espermicida ou abstinência) durante o período de tratamento e 1 mês depois; os homens devem utilizar um método eficaz de controlo de natalidade durante o período de tratamento e 3 meses depois.
    8. Expectativa de vida ≥ 90 dias (3 meses).
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a patient from enrollment:
    1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
    2. Any condition that confounds the ability to interpret data from the study.
    3. Other types of lymphomas, e.g. B-cell lymphoma.
    4. The following types of T cell lymphomas:
    a. Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
    b. Extranodal T-cell/NK-cell lymphoma, nasal type
    c. Anaplastic large cell lymphoma, ALK-positive type
    d. Cutaneous T cell lymphoma (mycosis fungoides, Sézary syndrome)
    e. Primary cutaneous CD30+ T-cell lymphoproliferative disorder
    f. Primary cutaneous anaplastic T-cell lymphoma
    5. Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of <=8 days) before randomization.
    6. Previous radiotherapy for PTCL except if localized to one lymph node area.
    7. Patients planned for autologous or allogeneic transplant as consolidation in first line.
    8. Central nervous system-meningeal involvement
    9. Contraindication to any drug contained in the chemotherapy regimen.
    10. Subjects with HIV positivity.
    11. Subjects with active hepatitis B or C. Chronic carriers of hepatitis B without HBV DNA positive blood are eligible after advice from hepatologist and initiation of prophylactic treatment if needed. Subjects with non-active hepatitis C (with normal transaminases) are eligible. Patients with HBc Ab+/ HBs Ab+/ HBs Ag- and HBV DNA- should be referred to an hepatologist and a prophylactic treatment should be initiated if needed.
    12. Any of the following laboratory abnormalities, except if secondary to the lymphoma:
    a. Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L),
    b. Platelet count < 100,000/mm3 (100 x 109/L), or < 75,000/mm3 if bone marrow is involved,
    c. Serum SGOT/AST or SGPT/ALT ≥ 3.0 x upper limit of normal (ULN),
    d. Serum total bilirubin > 2 x ULN, except in case of hemolytic anemia,
    e. K+ and Mg2+ levels < LLN, except if corrected per protocol guidance before beginning the romidepsin infusion.

    13. Serum creatinine > 2.0 x ULN
    14. Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
    15. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
    16. Any known cardiac abnormalities such as:
    a. Patients with congenital long QT syndrome,
    b. Corrected QT interval > 480 msec (using the Fridericia formula),
    c. Myocardial infarction within 6 months of cycle 1 day 1,
    d. History of or concomitant significant cardiovascular disease,
    e. Ejection fraction <45% by MUGA scan or by echocardiogram.

    17. Concomitant use of drugs that may cause a significant prolongation of the QTc.
    18. Patients who have received more than 200 mg/m2 doxorubicin.
    19. Concomitant use of strong CYP3A4 inhibitors (see Appendix)
    20. Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted.
    21. Clinically significant active infection.
    22. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug.
    23. Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study.
    1. Qualquer condição médica significativa, anomalia de laboratório ou doença psiquiátrica que poderia evitar a participação do doente no estudo.
    2. Qualquer condição que dificulte a capacidade de interpretar os dados do estudo.
    3. Outros tipos de linfomas, por exemplo, linfoma de células B
    4. Os seguintes tipos de linfomas T:
    a. Leucemia/linfoma T do adulto (linfoma T relacionado com VLTH-1)
    b. Linfoma extraganglionar de células T/células NK, tipo nasal
    c. Linfoma anaplásico de células grandes, tipo positivo para ALK
    d. Linfoma cutâneo de células T (micose fungóide, síndrome de Sézary)
    e. Distúrbio cutâneo primário linfoproliferativo de células T CD30+
    f. Linfoma cutâneo primário anaplásico de células T
    5. Tratamento prévio para PTCL com imunoterapia ou quimioterapia, exceto corticosteroides de ação curta (duração ≤ 8 dias) antes da aleatorização
    6. Radioterapia prévia para PTCL, exceto se está localizada numa área de gânglio linfático
    7. Doentes com transplante autólogo ou alogénico planejado como consolidação em primeira linha
    8. Envolvimento meníngeo – do sistema nervoso central
    9. Contraindicação a qualquer fármaco contido no regime de quimioterapia
    10. Doentes com positividade para o HIV
    11. Doentes com Hepatite B ou C ativa. Portadores crónicos de Hepatite B sem DNA HBV positivo em sangue são elegíveis depois de aconselhados pelo hepatologista e iniciação de tratamento profilático se necessário. Doentes com Hepatite C não-ativa (com transaminases) são elegíveis. Doentes com HBc Ab+/ HBs Ab+/ HBs Ag- e HBV DNA- devem ser referenciados a um hepatologista e tratamento profilático deve ser iniciado se necessário.
    12. Qualquer uma das seguintes anomalias de laboratório, exceto se se derivam do linfoma:
    a. Contagem absoluta de neutrófilos (RAN) < 1.500 células/mm3 (1,5 x 109/l),
    b. Contagem de plaquetas < 100.000/mm3 (100 x 109/l), ou < 75.000/mm3 se está envolvida a medula óssea
    c. SGOT/AST ou SGPT/ALT séricas ≥ 3,0 x limite superior da normalidade (ULN),
    d. Bilirrubina sérica total > 2 x ULN, exceto em caso de anemia hemolítica,
    e. Níveis de K+ e Mg2+ < LLN, exceto se foram corrigidos de acordo com a diretriz do protocolo antes de começar a perfusão de Romidepsina
    13. Creatinina sérica > 2,0 x ULN
    14. Antecedentes de neoplasia maligna distinta a linfoma (exceto carcinoma de células basais ou células escamosas da pele ou carcinoma in situ de colo do útero ou mama ou cancro prostático não tratado sem nenhum plano de tratamento) a menos que o doente tenha estado livre da doença durante ≥ 3 anos
    15. Qualquer condição médica grave, anomalia de laboratório ou doença psiquiátrica que pudesse evitar que o doente assinasse o consentimento informado
    16. Qualquer anomalia cardíaca conhecida tal como:
    a. Doentes com síndrome de QT longo congênito
    b. Intervalo QT corregido > 480 ms (a utilizar a fórmula de Fridericia)
    c. Infarto de miocárdio no prazo de 6 meses do dia 1 do ciclo 1
    d. Antecedentes ou presença concomitante de doença cardiovascular significativa
    e. Fração de ejeção <45% determinada mediante exploração MUGA ou mediante ecocardiograma;
    17. Utilização concomitante de fármacos que podem produzir uma prolongação significativa de QTc
    18. Doentes que receberam mais de 200 mg/m2 de Doxorubicina
    19. Utilização concomitante de inibidores de CYP3A4 fortes
    20. Utilização concomitante de warfarina terapêutica devido a uma possível interação farmacológica. Permite-se a utilização de uma dose baixa de warfarina ou de outro anticoagulante para manter a permeabilidade do acesso venoso e das cânulas.
    21. Infeção ativa clinicamente significativa
    22. Utilização de qualquer terapia farmacológica anticancerígena convencional ou experimental no prazo de 28 dias do início (dia 1) do fármaco do estudo
    23. Mulheres grávidas ou durante o período de aleitação ou mulheres em idade de procriar que não estão dispostas a utilizar um método adequado de controlo de natalidade durante a duração do estudo.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) assessed according to Progression criteria for malignant lymphoma 1999 by a Response adjudication committee.
    sobrevivência livre de progressão (SLP) avaliada de acordo com os Progression criteria for malignant lymphoma 1999 (Critérios de progressão para o linfoma maligno 1999) do Response Adjudication Committee (Comitê de avaliação de resposta) (RAC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessment (clinical examination, laboratory tests, pelvis, abdominal, chest and cervical CT scan, bone marrow examination) will be performed at baseline, at mid-treatment after 3 cycles (CT scan only) and 4 weeks after the last treatment dose. To ensure comparability, baseline and on-study methods for response assessment will be performed using identical techniques.
    Follow-up assessment, including CT Scan, will be clinical visit every 3 months the first year, then every 4 months the 2nd year, and every 6 months thereafter.
    avaliação tumoral (exploração física, análises clínicas, TAC de pelve, abdominal, torácica e cervical, exame de medula óssea) no nível inicial, após 3 ciclos de tratamento (só realiza-se um TAC) e 4 semanas após a última dose de tratamento. Para garantir a comparabilidade, avaliar-se-á a resposta ao início e durante o estudo a utilizar técnicas idênticas.
    A avaliação do acompanhamento, que inclui a TAC, realizar-se-á mediante visita em consulta cada 3 meses o primeiro ano, logo cada 4 meses o 2º ano e cada 6 meses a partir de então.
    E.5.2Secondary end point(s)
    • Overall survival
    • Overall Response Rate (ORR [PR+CR+CRu]) (according to the Response criteria for malignant lymphoma 1999)
    • Duration of response
    • Time to progression
    • Time to treatment failure
    • Safety
    • Quality of Life (QoL)
    • Response rates by PTCL histological subtypes
    • Response rate by standard prognostic parameters
    • Sobrevivência global
    • Taxa de resposta global (TRG [RP+RC+RCnc]) (de acordo com os Response criteria for malignant lymphoma 1999)
    • Duração da resposta
    • Tempo até a progressão
    • Tempo até o fracasso do tratamento
    • Segurança
    • Qualidade de vida (QoL)
    • Taxas de resposta por subtipos histológicos de PTCL
    • Taxa de resposta por parâmetros de prognóstico convencionais
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Overall survival: 2 years after the end of treatment
    • Overall Response Rate (ORR [PR+CR+CRu]): at the end of treatment
    • Duration of response: all duration of the study
    • Time to progression: all duration of the study
    • Time to treatment failure: all duration of the study
    • Safety: all duration of the study
    • Quality of Life (QoL) :At randomization, at D1 of cycle 4, at evaluation at the end of treatment, and during follow-up every 3 months the first year, every 4 months the second year and every year during follow-up period until primary analysis
    • Response rates by PTCL histological subtypes:at the end of treatment
    •Response rate by standard prognostic parameters: at the end of treatment
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    association of romidepsin and CHOP versus CHOP alone
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Democratic People's Republic of
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of the trial will be the end of follow up so approximately 6 years after the last patient randomized.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months6
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 420
    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)
    no difference
    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 Decision2014-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
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