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    Summary
    EudraCT Number:2006-000995-33
    Sponsor's Protocol Code Number:2006-000995-33
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-17
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2006-000995-33
    A.3Full title of the trial
    EuroNet-Paediatric Hodgkin’s Lymphoma Group:First international Inter-Group Study for classical Hodgkin’s Lymphoma in Children and
    Adolescents
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Building on the experience of the GPOH-HD study group since 1978, first and second line therapy for childhood Hodgkin’s lymphoma shall be further optimised to avoid over-treatment and decrease long-term complications.
    A.3.2Name or abbreviated title of the trial where available
    EuroNet-PHL-C1
    A.4.1Sponsor's protocol code number2006-000995-33
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00433459
    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 SponsorMartin Luther University of Halle/Wittenberg
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    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's lymphoma
    E.1.1.1Medical condition in easily understood language
    Therapy for childhood Hodgkin’s lymphoma shall be further optimised to avoid over-treatment and decrease long-term complications.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Are 5 year event free survival (EFS) rate estimates in patients
    with adequate response after 2 OEPA treated without radiotherapy consistent with a target EFS rate of 90% in all treatment groups? 2. Can Procarbazine be safely replaced by Dacarbazine in therapy groups TG-2 and TG-3 without a deterioration of EFS (randomised comparison of COPDAC and COPP)? 3. Description of treatment outcome to a standardised risk adapted relapse strategy
    E.2.2Secondary objectives of the trial
    1. Is the 5 year event free survival (EFS) rate in patients with
    inadequate response after 2 OEPA who receive standard
    involved field radiotherapy consistent with a target EFS rate of
    90% estimates in all treatment groups? 2. Does substitution of Dacarbazine for Procarbazine in TG-2 and -3 patients decrease the rate of infertility in males and premature menopause for females?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • diagnosis of classic Hodgkin’s lymphoma
    • patient aged under 18 years at time of diagnosis
    • written informed consent of the patient and/or the patient’s parents or guardian according to national laws
    E.4Principal exclusion criteria
    pre-treatment of Hodgkin’s lymphoma differing from study protocol (except recommended pre-phase therapy of a large mediastinal tumour) • known hypersensitivity or contraindication to study drugs
    • diagnosis of lymphocyte predominant Hodgkin’s lymphoma
    • prior chemotherapy or radiotherapy
    E.5 End points
    E.5.1Primary end point(s)
    Event free survival (EFS) defined as time from registration until the
    first of the following events:
    • progression/relapse of disease
    • diagnosis of a secondary malignancy
    • death of any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5-year EFS rates for TG-1 and TG-2 & -3 will be estimated (with
    95% confidence intervals) in patients with adequate response
    after 2 OEPA (and secondarily also in patients with inadequate
    response).
    E.5.2Secondary end point(s)
    1. Overall survival (OS) 2. Progression free survival (PFS)
    3. CTC (Common toxicity criteria) toxicity levels of therapy
    elements 4. Evidence of male infertility score / Female sexual functioning score 5. Long-term consequences (premature menopauses), secondary cancer etc.)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Long term follow-up.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) No
    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 No
    E.8.2.4Number of treatment arms in the trial5
    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 EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee 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
    Starting after the second year of recruitment annual intermediate analyses are intended if at least 80 randomised patients have a median observation time of at least 18 months. A proportional hazard model with the factors treatment group (TG-2 versus TG-3), SRA stratum and therapy (COPP versus COPDAC) is fitted. According to data of the pilot study with COPDAC dramatic differences are not to be
    expected.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 8
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    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 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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-30
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