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    Summary
    EudraCT Number:2012-004053-88
    Sponsor's Protocol Code Number:EuroNet-PHL-C2
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2012-004053-88
    A.3Full title of the trial
    EuroNet-Paediatric Hodgkin’s Lymphoma Group

    Second International Inter-Group Study
    for Classical Hodgkin’s Lymphoma in Children and Adolescents
    Europejska Sieć Chłoniaka Hodgkina: Drugie międzynarodowe, międzygrupowe badanie dotyczące leczenia klasycznej postaci chłoniaka Hodgkina u dzieci i młodzieży.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EuroNet-Paediatric Hodgkin’s Lymphoma Group

    Second trial conducted by European experts in the field for treating Classical Hodgkin’s Lymphoma in Children and Adolescents
    Europejska Sieć Chłoniaka Hodgkina: Drugie międzynarodowe, międzygrupowe badanie dotyczące leczenia klasycznej postaci chłoniaka Hodgkina u dzieci i młodzieży.
    A.3.2Name or abbreviated title of the trial where available
    EuroNet-PHL-C2
    A.4.1Sponsor's protocol code numberEuroNet-PHL-C2
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02684708
    A.5.4Other Identifiers
    Name:Amendment 04Number:final
    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 SponsorJagiellonian University Medical College
    B.1.3.4CountryPoland
    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 supportJagiellonian University Medical College
    B.4.2CountryPoland
    B.4.1Name of organisation providing supportFoundation for Children with Cancer
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationprof. Walentyna Balwierz (Klinika Onkologii i Hematologii Dziecięcej SU)
    B.5.2Functional name of contact pointTrial Coordinator in Poland
    B.5.3 Address:
    B.5.3.1Street AddressWielicka 265
    B.5.3.2Town/ cityKrakow
    B.5.3.3Post code30663
    B.5.3.4CountryPoland
    B.5.4Telephone number+4812333 92 20
    B.5.5Fax number+4812658 76 51
    B.5.6E-mailwalentyna.balwierz@uj.edu.pl
    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.2.5The 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.3.2Product code VCR
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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.3.9.2Current sponsor codeVCR
    D.3.9.4EV Substance CodeSUB00059MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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: 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 nameEtoposide, Etopophos
    D.3.2Product code ETO
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETOPOSIDE
    D.3.9.2Current sponsor codeETOP
    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: 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 namePrednisone
    D.3.2Product code PRED
    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.3.9.2Current sponsor codePRED
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    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 nameDoxorubicin
    D.3.2Product code DOX
    D.3.4Pharmaceutical form Concentrate and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    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.3.11 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.3.2Product code CYC
    D.3.4Pharmaceutical form Powder and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    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.3.9.2Current sponsor codeCYC
    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 nameDacarbazine
    D.3.2Product code DAC
    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 drip use (Noncurrent)
    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.3.9.2Current sponsor codeDAC
    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: 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 nameVinblastine
    D.3.2Product code VBL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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.3.9.2Current sponsor codeVBL
    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: 8
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The 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 namePrednisolone
    D.3.2Product code PREDNISOLONE
    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 INNPREDNISOLONE
    D.3.9.3Other descriptive namePREDNISOLONE
    D.3.9.4EV Substance CodeSUB10018MIG
    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
    Hodgkin lymphoma in children and adolescents
    Chłoniak Hodgkina (klasyczna postać - cHL) występujący u dzieci i młodzieży do lat 18
    E.1.1.1Medical condition in easily understood language
    Cancer which affects lymph nodes and lymphatic tissue in children and young people, named Hodgkin lymphoma
    Złośliwy nowotwór układu chłonnego u dzieci i młodzieży do lat 18, o nazwie Chłoniak Hodgkina
    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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    3.4.1.1 Randomised
    1. To increase event-free survival in ERA(early response assessment) PET-negative intermediate and advanced stage patients (TL-2 and TL-3) without radiotherapy by using intensified consolidation chemotherapy (DECOPDAC-21).

    2. To demonstrate in ERA PET-positive TL-2 and TL-3 patients that the combination of intensified consolidation chemotherapy (DECOPDAC-21) plus restricted field RT to sites that remain FDG-PET positive at the late response assessment (LRA) is comparable to the standard consolidation chemotherapy (COPDAC-28) plus standard involved node radiotherapy.

    3.4.1.2 Non-randomised
    3. To further reduce the radiotherapy indication in early stage patients by increasing the threshold for a positive FDG PET scan at early response assessment (ERA) to Deauville 4+ while still preserving a 5 year EFS estimate at a target of 90% or above.
    1. Pacjenci randomizowani
    a. Zwiększenie odsetka EFS w grupie pacjentów z ujemnym wynikiembadania PET uzyskanym w ERA w TL-2 i TL-3 bez zastosowania radioterapii poprzez zintensyfikowanie chemioterapii konsolidacyjnej(DECOPDAC-21).
    b. Wykazanie, że u pacjentów z dodatnim wynikiem badania PETuzyskanym w ERA w TL-2 i TL-3 leczonych zintensyfikowaną chemioterapią DECOPDAC-21 w skojarzeniu i z radioterapią ograniczoną do obszarów FDG-PET pozytywnych po zakończeniu chemioterapii, daje porównywalne wyniki, jak leczenie z użyciem standardowej chemioterapii COPDAC-28 z radioterapią wstępnie zajętych węzłów chłonnych.
    2. Pacjenci nierandomizowani
    a. Dalsze ograniczenie wskazań do radioterapii u pacjentów we wczesnych stadiach cHL przez przesunięcie wartości progowej pozytywnego wyniku badania FDG-PET, wykonanego w czasie wczesnej oceny odpowiedzi na leczenie do 4+ stopnia skali Deauville, przy jednoczesnym utrzymaniu odsetka 5-letnich EFS na poziomie min. 90%.
    E.2.2Secondary objectives of the trial
    1. Evaluation of haematotoxicity by documentation of blood count courses during OEPA, COPDAC-28 and DECOPDAC-21 cycles and comparison between COPDAC-28 versus DECOPDAC-21.
    2. For ERA PET-positive patients to compare the LRA PET-positivity rates after consolidation chemotherapy with COPDAC-28 or DECOPDAC-21.
    1. Ocena toksyczności hematologicznych na podstawie udokumentowanych wyników badań morfologii krwi obwodowej w trakcie chemioterapii COPDAC-28 i DECOPDAC-21.
    2. Porównanie w grupie pacjentów ERA PET-dodatnich odsetka pozytywnych wyników badań LRA PET uzyskanych po zastosowaniu chemioterapii COPDAC-28 lub DECOPDAC-21
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • histologically confirmed primary diagnosis of classical Hodgkin’s lymphoma
    • patients under 18 years of age on the date of written informed consent. In specialized Teenage and Young Adult (TYA) units in France, Italy and UK patients up to under 25 years of age can also be enrolled. Lower age limits will be country specific according to national laws or formal insurance requirements that may preclude very young patients.
    • written informed consent of the patient and/or the patient’s parents or guardian according to national laws
    • negative pregnancy test within 2 weeks prior to starting treatment for female patients with childbearing potential
    • Chorzy z potwierdzonym histologicznie rozpoznaniem cHL
    • Pacjenci w wieku poniżej 18 lat w chwili pisemnego udzielania świadomej zgody na udział w badaniu.
    • Świadoma zgoda na udział w badaniu wyrażona pisemnie przez pacjenta i/lub przez rodziców pacjenta lub opiekuna prawnego
    • Negatywny wynik testu ciążowego, wykonanego w ciągu 2 tygodni
    poprzedzających rozpoczęcie badania u pacjentek w wieku rozrodczym
    E.4Principal exclusion criteria
    • prior chemotherapy or radiotherapy for other malignancies
    • pre-treatment of Hodgkin’s lymphoma (except for 7-10 days steroid pre-phase of a large mediastinal tumour)
    • diagnosis of lymphocyte-predominant Hodgkin’s lymphoma
    • other (simultaneous) malignancies
    • contraindication or known hypersensitivity to study drugs
    • severe concomitant diseases (e.g. immune deficiency syndrome)
    • known HIV-positivity
    • residence outside the participating countries where long term follow-up cannot be guaranteed
    • pregnancy and/or lactation
    • patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment
    • current or recent (within 30 days prior to date of written informed consent) treatment with another investigational drug or participation in another interventional clinical trial
    •Wcześniej stosowana chemioterapia lub radioterapia z powodu innego nowotworu
    •Wcześniejsze leczenie cHL (z wyjątkiem pierwszych 7-10 dni zalecanej profazy sterydowej w przypadku dużego guza w śródpiersiu)
    •Rozpoznanie postaci chłoniaka Hodgkina z przewagą limfocytów
    •Inne (współistniejące) nowotwory
    •Przeciwwskazania do stosowania lub znana nadwrażliwość na leki stosowane w badaniu
    •Ciężkie współistniejące choroby (np. niedobory odporności)
    •Potwierdzone zakażenie wirusem HIV
    •Zamieszkanie poza terytorium kraju biorącego udział w badaniu, gdy nie może być zapewniony odpowiednio długi okres obserwacji
    •Ciąża i/lub okres karmienia piersią
    •Pacjenci aktywni seksualnie i nie wyrażający zgody na stosowanie skutecznych metod antykoncepcyjnych w trakcie prowadzenia terapii oraz przez jeden rok po zastosowaniu ostatniego elementu leczenia.
    •Obecność lub wcześniejsze (w ciągu 30 dni poprzedzających uzyskanie pisemnej zgody na udział w programie) leczenie innym badanym lekiem lub udział w innym programie badawczym
    E.5 End points
    E.5.1Primary end point(s)
    3.5.1 Primary efficacy endpoint
    • Event-free survival (EFS) defined as time from start of treatment until the first of the following events:
    o progression/relapse of disease
    o secondary malignancy
    o death from any cause
    Przeżycie wolne od niekorzystnych wydarzeń (ang. event-free survival, EFS) zdefiniowane jako czas upływający od rozpoczęcia leczenia do wystąpienia następujących wydarzeń:
    • Progresji lub wznowy choroby
    • Rozpoznania drugiego nowotworu
    • Zgonu, niezależnie od przyczyny
    E.5.1.1Timepoint(s) of evaluation of this end point
    Descriptive data analyses will be performed annually checking data integrity, monitoring study performance quality endpoints as well as describing treatment related toxicities for the annual safety report.
    The clinical board of EuroNet-PHL will decide on adequate measures in response to potential findings. The DMC may be consulted for independent guidance if there is a potential change in the risk-benefit analysis or lack of consensus in the clinical board.
    Interim analyses on efficacy will be performed annually starting in year three after the start of accrual when a meaningful number of patients will be on study for more than one year.
    Opisowa analiza danych będzie wykonywana raz w roku w celu kontroli integralności danych, monitorowania wydajności badania, jakości punktów końcowych, a także opisu zabiegów związanych z toksycznością dla rocznego raportu o bezpieczeństwie. Analizy częściowe (interim analyses) dotyczące skuteczności będą wykonywane corocznie począwszy od trzeciego roku po rozpoczęciu naliczania, gdy znacząca liczba pacjentów będzie po badaniu przez okres dłuższy niż jeden rok.
    E.5.2Secondary end point(s)
    3.5.2 Secondary endpoints
    • Efficacy: overall survival (OS), progression-free survival (PFS)
    • Safety: CTC (common toxicity criteria) grading during any individual treatment element including assessment of osteonecrosis
    • Quality:
    o Time from day of PET imaging until decision on response category at ERA or LRA, respectively
    o Time from last day of chemotherapy to first day of radiotherapy in patients with radiotherapy indication
    o Time from last dose of prednisone/prednisolone in OEPA to start of the first consolidation cycle
    o Duration of chemotherapy
    o Chemotherapy dose actually administered divided by scheduled total dose for each drug
    o Discontinuation or substitution rate for each drug
    o Time from FDG-Injection to start of PET acquisition
    o Proportion of patients with enhanced FDG-uptake in brown fat under use of beta-blockers
    o Average liver FDG-uptake at staging, ERA and LRA (reproducibility)
    o Applied FDG-dose in relation to the EANM paediatric dosage card recommendation
    o Applied radiation dose in low dose PET-CT (tube current, tube voltage and rotation time)
    o Duration of radiotherapy, radiotherapy discontinuation rate
    o Delivery of radiotherapy according to protocol guidelines.
    o Skuteczność: uzyskane odsetki przeżycia całkowitego (ang. overall survival, OS), przeżycia wolnego od progresji choroby (ang. progression free survival, PFS).
    o Bezpieczeństwo: stopień toksyczności stosowanych elementów terapii wg CTC (ang. Common Toxicity Criteria), ze szczególnym uwzględnieniem przypadków jałowej martwicy kości.
    o Jakość:
    • Czas od dnia badania PET do dnia, w którym przeprowadzono ocenę odpowiedzi na leczenie (ERA lub LRA)
    • Czas między ostatnim dniem chemioterapii a pierwszym dniem radioterapii (u pacjentów zakwalifikowanych radioterapii)
    • Czas od ostatniej dawki prednizonu/prednizolonu w cyklu OEPA do rozpoczęcia pierwszego cyklu chemioterapii konsolidacyjnej
    • Całkowity czas trwania chemioterapii
    • Odnotowanie podanej dawki każdego leku przeciwnowotworowego w odniesieniu do przewidzianej protokołem dawki
    • Częstość zaprzestania stosowania lub zamiany poszczególnych leków przeciwnowotworowych
    • Czas od dożylnego podania FDG do aktywizacji badania FDG-PET
    • Odsetek pacjentów ze zwiększonym wychwytem FDG w brunatnej tkance tłuszczowej, utrzymującym się po zastosowaniu beta-blokerów
    • Uśredniony wychwyt FDG dla wątroby w trakcie oceny stopnia zaawansowania i wczesnej oraz późnej oceny odpowiedzi na leczenie (ERA i LRA) - ocena powtarzalności wyników
    • Dawka FDG zastosowana w trakcie badania PET w odniesieniu do zaleceń EANM zawartych w karcie pediatrycznej
    • Dawka promieniowania zastosowana w nisko dawkowanym badaniu PET-CT (natężenie prądu w lampie, napięcie i czas rotacji lampy)
    • Czas trwania radioterapii, odsetek pacjentów, u których nie zastosowano radioterapii (brak kwalifikacji do radioterapii zgodnie z zaleceniami protokołu)
    • Zastosowanie radioterapii zgodnie z wytycznymi przedstawionymi w protokole
    E.5.2.1Timepoint(s) of evaluation of this end point
    Descriptive data analyses will be performed annually checking data integrity, monitoring study performance quality endpoints as well as describing treatment related toxicities for the annual safety report.
    The clinical board of EuroNet-PHL will decide on adequate measures in response to potential findings. The DMC may be consulted for independent guidance if there is a potential change in the risk-benefit analysis or lack of consensus in the clinical board.
    Interim analyses on efficacy will be performed annually starting in year three after the start of accrual when a meaningful number of patients will be on study for more than one year.
    Opisowa analiza danych będzie wykonywana raz w roku w celu kontroli integralności danych, monitorowania wydajności badania, jakości punktów końcowych, a także opisu zabiegów związanych z toksycznością dla rocznego raportu o bezpieczeństwie. Analizy częściowe (interim analyses) dotyczące skuteczności będą wykonywane corocznie począwszy od trzeciego roku po rozpoczęciu naliczania, gdy znacząca liczba pacjentów będzie po badaniu przez okres dłuższy niż jeden rok.
    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) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    2 lub 4 cykle zintensyfikowanej konsolidacyjnej chemioterapii DECOPDAC-21
    two or four intensified DECOPDAC-21 consolidation chemotherapy cycles
    E.8.2.4Number of treatment arms in the trial3
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    Australia
    Austria
    Belgium
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Ireland
    Israel
    Italy
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Slovakia
    Slovenia
    Spain
    Switzerland
    United Kingdom
    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 recruitment period is expected to last six years (in Germany a maximum of five years for insurance reasons). The follow-up period will be five years after start of treatment. Individual trial participation ends with a last visit 60 months after start of treatment. After the individual end of study, the patients enter a follow-up observational protocol (outside the EuroNet-PHL-C2-trial).
    The EuroNet-PHL-C2-trial formally ends with the last visit of the last patient (=LVLS).
    Okres rekrutacji pacjentów wynosi 6 lat (w Niemczech max.5 lat). Okres obserwacji (follow-up) zaplanowano na 5 lat od rozpoczęcia leczenia. Indywidualny czas zakończenia udziału w badaniu każdego pacjenta wyznacza ostatnia wizyta kontrolna (60 miesięcy od zakończenia leczenia =indywidualne zakończenie badania), następnie pacjent włączany będzie do obserwacyjnego protokołu (follow-up). Badanie zostanie formalnie zamknięte z chwilą ostatniej wizyty ostatniego pacjenta włączonego do badania (LPLV).
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days29
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2200
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 500
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1700
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Before trial entry written informed consent of the child’s/adolescent’s parent/guardian is mandatory. The assent for trial participation will be taken into account. The subject will be informed about the trial using age-specific patient information.
    Przed włączeniem niepełnoletniego uczestnika do badania konieczne jest uzyskanie świadomej zgody przedstawicieli ustawowych pacjenta. W przypadku pacjentów powyżej 16 r.ż konieczne jest uzyskanie również świadomej zgody od pacjenta.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state290
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1800
    F.4.2.2In the whole clinical trial 2200
    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)
    All patients will be followed-up for 5 years. After the individual study end (i.e. at 5 years after study entry), the patients will be enrolled in an observational protocol to assess long-term sequelae. This registry is not part of this trial.
    The EuroNet-PHL-C2 trial will terminate with the 5-year follow-up (last visit) of the last patient enrolled.
    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 Decision2018-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-25
    P. End of Trial
    P.End of Trial StatusOngoing
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