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    Summary
    EudraCT Number:2017-000498-35
    Sponsor's Protocol Code Number:EORTC-1537-LYMG
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-20
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2017-000498-35
    A.3Full title of the trial
    Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II study
    Cielená liečba pokročilého Hodgkinovho lymfómu prispôsobená podľa veľmi skorej odpovede podľa FDG-PET: skúšanie fázy II s jedným ramenom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II study
    Cielená liečba pokročilého Hodgkinovho lymfómu prispôsobená podľa veľmi skorej odpovede podľa FDG-PET: skúšanie fázy II s jedným ramenom
    A.3.2Name or abbreviated title of the trial where available
    COBRA
    COBRA
    A.4.1Sponsor's protocol code numberEORTC-1537-LYMG
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03517137
    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 SponsorEuropean Organisation for Research and Treatment of Cancer (EORTC)
    B.1.3.4CountryBelgium
    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 supportEORTC
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportMillennium Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisation for Research and Treatment of Cancer (EORTC)
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressAvenue E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227741052
    B.5.5Fax number+3227727063
    B.5.6E-mailregulatory@eortc.org
    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 Adcetris
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/08/596
    D.3 Description of the IMP
    D.3.1Product nameBrentuximab vedotin
    D.3.2Product code SGN-35
    D.3.4Pharmaceutical form Powder for 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 INNBrentuximab vedotin
    D.3.9.1CAS number 914088-09-8
    D.3.9.3Other descriptive nameBRENTUXIMAB VEDOTIN
    D.3.9.4EV Substance CodeSUB32397
    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 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: 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.2.5The 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 nameAdriamycin
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameAdriamycin
    D.3.9.4EV Substance CodeSUB06391MIG
    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.2.5The 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 nameVinblastine
    D.3.4Pharmaceutical form 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 INNVINBLASTINE
    D.3.9.1CAS number 865-21-4
    D.3.9.4EV Substance CodeSUB00052MIG
    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.2.5The 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 nameDacarbazine
    D.3.4Pharmaceutical form 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 INNDACARBAZINE
    D.3.9.1CAS number 4342-03-4
    D.3.9.4EV Substance CodeSUB06882MIG
    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.2.5The 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.3.11 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.2.5The 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 nameEtoposide
    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 INNEtoposide
    D.3.9.3Other descriptive nameETOPOSIDE
    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: 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.2.5The 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 nameDexamethasone
    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 INNDEXAMETHASONE
    D.3.9.3Other descriptive nameDexamathasone
    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.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
    Advanced stage Hodgkin Lymphoma
    Pokročilé štádium Hodgkinovho lymfómu
    E.1.1.1Medical condition in easily understood language
    Lymphoma
    lymfómu
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080208
    E.1.2Term Classical Hodgkin lymphoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10020206
    E.1.2Term Hodgkin's disease
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10020243
    E.1.2Term Hodgkin's disease NEC
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025319
    E.1.2Term Lymphomas Hodgkin's disease
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10005329
    E.1.2Term Blood and lymphatic system disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 main objective of this trial is to assess whether treatment adaptation based on a very early FDG-PET/CT results in improved efficacy while minimizing treatment toxicity in advanced stage HL patients treated with BV-containing regimens, BrAVD and BrECADD.
    This will be primarily assessed by modified progression-free survival.
    Hlavným cieľom tohto skúšania je posúdiť, či úprava liečby založená na veľmi skorej odpovede podľa FDG-PET/CT vedie k zlepšeniu účinnosti pri súčasnom minimalizovaní toxicity liečby u pacientov s pokročilým štádiom Hodgkinovho lymfómu (HL) liečeného režimami zahŕňajúcimi Brentuximab vedotín, BrAVD a BrECADD. Toto bude primárne hodnotené modifikovaným prežitím bez progresie.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To assess the rate of FDG-PET negativity (Deauville score 1-3) after 1 cycle of BrAVD
    • To assess response according to Lugano Criteria at end of protocol treatment i.e. after chemotherapy and after radiotherapy (if administered), as defined by FDG-PET/CT
    • To assess the safety and tolerability of the different BV containing regimens
    • To assess the safety and tolerability of radiotherapy in the context of BrAVD and BrECADD
    • To assess efficacy in terms of PFS and OS
    Sekundárnymi cieľmi sú:
    • Posúdiť rýchlosť nástupu FDG-PET negativity (Deauville skóre 1-3) po 1 cykle BrAVD
    • Posúdiť odpoveď podľa Luganských kritérií na konci liečby, t. J. po chemoterapii a po rádioterapii (ak sa podáva), ako je definované v FDG-PET / CT
    • Posúdiť bezpečnosť a toleranciu rôznych režimov obsahujúcich BV
    • Posúdiť bezpečnosť a toleranciu rádioterapie v kontexte BrAVD a BrECADD
    • Posúdiť účinnosť v zmysle PFS a OS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Previously untreated, histologically proven classical Hodgkin lymphoma;
    • Staged by PET with diagnostic-quality CT.
    - Clinical stages according to Lugano 2014 and based on FDG/PET CT:Stage IIB with large mediastinal mass > 1/3 max transverse diameter thorax and/or extranodal lesion(s) (GHSG)
    - Stage III - IV
    • Participation in translational research is mandatory and therefore patient must consent to additional blood samples at multiple time points
    in the study. In addition, sufficient tissue must be available (15 blank
    formalin fixed paraffin embedded tissue samples mounted on APES slides or a tissue block).
    • Age ≥18 and ≤60
    • WHO performance status 0-2
    • Patient demonstrates adequate organ function as defined in the protocol.
    • Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment.
    • Patients of childbearing / reproductive potential should use two birth control methods, as defined by the investigator, from the time of signing the informed consent form , and throughout the entire study and for 6 months after the last dose of treatment.
    • Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
    • Absence of any medical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    • Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
    • Predtým neliečený, histologicky preukázaný klasický Hodgkinov lymfóm;
    • CT diagnostickej kvality so štádiom stanoveným podľa PET.
    - Klinické štádiá podľa Lugana 2014 a založené na FDG/PET CT: štádium IIB s veľkou mediastinálnou hmotnosťou> 1/3 max priečneho priemeru hrudníka a/alebo extranodálnej lézie (GHSG)
    - Štádium III – IV
    •Účasť na translačných výskumoch je povinná, a preto musí pacient súhlasiť. Nasledujúci materiál musí byť k dispozícii:
    vzorky krvi vo viacerých časových intervaloch štúdie. Naviac, dostatočné tkanivové vzorky musia byť k dispozícii dostupné archívne tkanivá nádoru (15 vzoriek tkanív uložených v parafíne fixovaných formalínom položených na APES sklíčkách alebo tkanivový blok).
    • Vek ≥18 a ≤60
    • Stav výkonnosti 0-2 podľa WHO
    • Pacient preukazuje adekvátnu funkciu orgánu, ako je definované v protokole.
    • Ženy v plodnom veku (WOCBP) musia mať negatívny sérový tehotenský test do 72 hodín pred prvou dávkou skúšanej liečby.
    • Pacientky v plodnom veku alebo s reprodukčným potenciálom by mali používať dve metódy antikoncepcie definované skúšajúcim od podpisu formulára informovaného súhlasu a počas celého skúšania a 6 mesiacov po poslednej dávke liečby.
    • Dojčiace účastníčky by mali prerušiť dojčenie pred prvou dávkou skúšanej liečby a 6 mesiacov po poslednej skúšanej liečbe.
    • Neprítomnosť akéhokoľvek zdravotného, psychologického, rodinného, sociologického alebo geografického stavu, ktorý by mohol brzdiť komplianciu protokolu skúšania a harmonogramu ďalšieho sledovania, tieto podmienky by sa mali pred registráciou do skúšania prebrať s pacientom
    • Pred registráciou pacienta sa musí vykonať písomný informovaný súhlas uvedený podľa ICH/GCP (správnej klinickej praxe medzinárodnej konferencie o harmonizácii) a národných/miestnych predpisov.
    E.4Principal exclusion criteria
    • Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencenphalopathy
    • Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
    • Sensory or motor peripheral neuropathy greater than or equal to grade 2 according to CTCAE version 5.0
    • Any of the following cardiovascular conditions or values:
    - within 6 months before registration:
    • A left-ventricular ejection fraction <50%
    • New York Heart Association (NYHA) Class III or IV heart failure.
    • Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
    • symptomatic coronary heart disease (stable angina pectoris is allowed)
    • severe uncontrolled hypertension defined as blood pressure (BP) >150/100 mmHg despite optimal antihypertensive treatment
    - within 2 years before registration:
    • Myocardial infarction
    • Patients with poorly controlled diabetes mellitus (HbA1c > 7.5 % or a fasting blood sugar > 200 mg/dL).
    • Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to registration.
    • Known HIV infection, chronic active hepatitis C, HBV positivity (HBsAg + patients; HBsAg -/HBcAb+/HBV DNA+ patients).
    Note: HBsAg-/HBV DNA – patients are eligible; patients who are seropositive due to vaccination are eligible
    • Concomitant or previous malignancies within the past 5 years with the exception of adequately treated carcinoma in situ of the cervix , nonmelanoma skin cancer.
    • Previous treatment with anti CD30 antibodies
    • Known hypersensitivity to any excipient contained in Brentuximab Vedotin formulation and other study drugs. Refer to Summary Product Characteristics for list of excipients.
    • Concurrent anti-cancer treatment or use of any investigational agent(s)
    • Známe mozgové alebo meningeálne ochorenie (HL alebo akákoľvek iná etiológia) vrátane príznakov alebo symptómov progresívnej multifokálnej leukoencenfalopatie
    • Symptomatická neurologická choroba ohrozujúca normálne aktivity každodenného života alebo vyžadujúca si lieky
    • Senzorická alebo motorická periférna neuropatia vyššia alebo rovná stupňu 2 podľa CTCAE verzie 5.0
    • Ktorékoľvek z nasledujúcich kardiovaskulárnych ochorení alebo hodnôt:
    - do 6 mesiacov pred registráciou:
    • Ejekčná frakcia ľavej komory <50 % (pri registrácii)
    • Zlyhanie srdca triedy III alebo IV podľa asociácie New York Heart Association (NYHA).
    • Dôkaz o súčasných nekontrolovaných kardiovaskulárnych stavoch vrátane srdcových arytmií, kongestívneho zlyhania srdca (CHF), angíny pectoris alebo elektrokardiografického dôkazu akútnej ischémie alebo abnormalít aktívneho vodivého systému
    • Symptomatické koronárne ochorenie srdca (je povolená stabilná angína pectoris)
    • Závažná nekontrolovaná hypertenzia definovaná ako tlak krvi (TK) >150/100 mmHg napriek optimálnej antihypertenznej liečbe
    - do 2 rokov pred registráciou:
    • Infarkt myokardu
    • Pacienti s nedostatočne kontrolovaným diabetom mellitus (HbA1c > 7,5 % alebo hladinou cukru v krvi nalačno > 200 mg/dl).
    • Akákoľvek aktívna systémová vírusová, bakteriálna alebo plesňová infekcia vyžadujúca systémové antibiotiká do 2 týždňov pred registráciou.
    • Známa infekcia HIV, chronická aktívna hepatitída C, HBV pozitivita (pacienti s HBsAg+, pacienti s HBsAg–/HBcAb/HBV DNA).
    Poznámka: Pacienti s HBsAg–/HBV DNA – spĺňajú podmienky; pacienti, ktorí sú séropozitívni v dôsledku očkovania, spĺňajú podmienky
    • Konkominantné alebo predchádzajúce malignity za posledných 5 rokov s výnimkou adekvátne liečeného karcinómu in situ v krčku maternice, nemelanómovej rakoviny kože.
    • Predchádzajúca liečba protilátkami proti CD30
    • Známa precitlivenosť na ktorúkoľvek pomocnú látku obsiahnutú vo formulácii Brentuximab vedotín a iné skúšané lieky.
    • Súbežná protinádorová liečba alebo použitie akéhokoľvek skúmaného činidla (činidiel)
    E.5 End points
    E.5.1Primary end point(s)
    Modified progression-free survival rate at 2 years after start of treatment (2yr-mPFS for each patient).
    The following are considered events for the primary endpoint: progression/relapse; start of new treatment for cHL when not in CR after completing protocol treatment; death from any cause.
    Modifikovaná miera prežívania bez progresie po 2 rokoch (2yr-mPFS pre každého pacienta). Pre primárny ukazovateľ sa zvažujú nasledujúce udalosti:
    progresia / relaps; začiatok novej liečby cHL, ak nie je v CR na konci liečby podľa protokolu; smrť z akejkoľvek príčiny.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Modified progression-free survival rate at 2 years. Modified PFS is defined as the time interval between the treatment start date and the date of the first of:
    • Progressive disease (PD)
    • Start of new treatment for cHL when not in CR at the end of protocol treatment; in this case, the date of mPFS is the date of the FDG-PET/CT scan at the end of protocol treatment. Switching therapy prior to end of protocol treatment for reasons other than PD is not considered an event for mPFS. "End of protocol treatment" refers to completion of the planned protocol treatment with no more than 1 missed cycle, including radiotherapy on PET positive lesions if administered
    • Death due to any cause
    Patients without any of these events will be censored at the last response assessment date.
    Modifikovaná miera prežívania bez progresie po 2 rokoch. mPFS je definovaná ako časový interval medzi dátumom začatia liečby a dátumom prvého z nasledujúcich prípadov
    • Progresívne ochorenie
    • Začiatok novej liečby cHL, ak nie je v CR na konci liečby podľa protokolu; v tomto prípade je dátum mPFS dátumom FDG-PET/vyšetrenia CT na konci liečby podľa protokolu. Zmena liečby pred ukončením liečby podľa protokolu z iných dôvodov, ako progresia ochorenia, sa nepovažuje za udalosť pre mPFS. „Ukončenie liečby podľa protokolu“ sa týka dokončenia plánovanej liečby podľa protokolu s najviac jedným vynechaným cyklom vrátane rádioterapie na léziách pozitívnych na PET, ak sa vykoná
    • Smrť z akejkoľvek príčiny
    Pacienti bez týchto udalostí budú cenzurovaní v deň posledného hodnotenia odpovede.
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • FDG-PET result (positive/negative) after 1 cycle of BrAVD (central
    assessment).
    • Response according to Lugano Criteria at end of protocol treatment i.e. after chemotherapy and after radiotherapy (if administered), as defined by FDG-PET/CT
    • Progression-free survival (where progression, relapse and death from any cause are considered events).
    • Overall survival
    • Safety and tolerability
    • Response according to RECIL 2017
    Sekundárne ukazovatele:
    • výsledokFDG-PET vyšetrenia (pozitívne/negatívne) po prvom cykle BrAVD;
    • liečebná odpoveď podľa kritérií Lugano na konci liečby podľa protokolu, t. j. po chemoterapii, aj po rádioterapii (ak sa podáva) ako sú definované FDG-PET/CT vyšetrením;
    • prežívanie bez progresie (v prípade, že progresia, relaps a smrť z akejkoľvek príčiny sa považujú za udalosti);
    • celkové prežitie;
    • miera odpovede podľa RECIL 2017.
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 years after end of treatment
    5 rokov po ukončení liečby
    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 Yes
    E.6.13.1Other scope of the trial description
    Treatment strategy based on FDG-PET results
    Stratégia liečby založená na výsledkoch FDG-PET
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned 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 EEA23
    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
    Egypt
    Belgium
    Croatia
    Denmark
    France
    Netherlands
    Poland
    Portugal
    Slovakia
    Spain
    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
    End of study occurs when all of the following criteria have been satisfied:
    • All patients have completed their end of study visit. If a participant discontinues the follow-up for one
    of the following reasons: withdrawal of consent, loss to follow-up, or death, the end of study participation is defined as the time point when one of these events occurred.
    • The trial is mature for all analyses defined in the protocol and the
    database has been cleaned and frozen for these analyses.
    Koniec štúdia nastane, keď sú splnené všetky nasledujúce kritériá:
    • Všetci pacienti ukončili návštevu na konci štúdie. Ak účastník preruší sledovanie pre jedného
    z nasledujúcich dôvodov: odvolanie súhlasu, strata sledovania alebo smrť, je koniec účasti v štúdii definovaný ako časový bod, kedy nastala jedna z týchto udalostí.
    • Skúška je zrelá pre všetky analýzy definované v protokole a protokole
    databáza bola pre tieto analýzy vyčistená a zmrazená.
    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 days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    According to the discretion of the treating physician.
    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 Decision2019-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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