Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44365   clinical trials with a EudraCT protocol, of which   7389   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    EuroNet-Paediatric Hodgkin’s Lymphoma Group Second International Inter-Group Study for Classical Hodgkin’s Lymphoma in Children and Adolescents

    Summary
    EudraCT number
    		 2012-004053-88
    Trial protocol
    		 DE   BE   AT   CZ   ES   IT   NL   DK   FR   PL   FI   GB   SE   NO  
    Global end of trial date
    31 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Dec 2025
    First version publication date
    12 Dec 2025
    Other versions
    Summary report(s)
    		 Synopsis ICH E3

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EuroNet-PHL-C2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Amendment 7 international: Amendment 7 international
    Sponsors
    Sponsor organisation name
    Justus-Liebig-University
    Sponsor organisation address
    Rudolf-Buchheim-Str. 23, Giessen-Marburg, Germany, 35392
    Public contact
    Zentrum für Kinderheilkunde, Justus Liebig University of Giessen, +49 641 9854342, dieter.koerholz@paediat.med.uni-giessen.de
    Scientific contact
    Zentrum für Kinderheilkunde, Justus Liebig University of Giessen, +49 641 9854342, dieter.koerholz@paediat.med.uni-giessen.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Oct 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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.
    Protection of trial subjects
    Patients were closely monitored by the treatment team with regard to safety.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 127
    Country: Number of subjects enrolled
    New Zealand: 34
    Country: Number of subjects enrolled
    Norway: 37
    Country: Number of subjects enrolled
    Czechia: 65
    Country: Number of subjects enrolled
    Israel: 151
    Country: Number of subjects enrolled
    Switzerland: 51
    Country: Number of subjects enrolled
    Netherlands: 124
    Country: Number of subjects enrolled
    Poland: 112
    Country: Number of subjects enrolled
    Spain: 155
    Country: Number of subjects enrolled
    Sweden: 24
    Country: Number of subjects enrolled
    United Kingdom: 169
    Country: Number of subjects enrolled
    Austria: 90
    Country: Number of subjects enrolled
    Belgium: 111
    Country: Number of subjects enrolled
    Denmark: 21
    Country: Number of subjects enrolled
    France: 332
    Country: Number of subjects enrolled
    Germany: 715
    Country: Number of subjects enrolled
    Italy: 556
    Worldwide total number of subjects
    2874
    EEA total number of subjects
    2342
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    573
    Adolescents (12-17 years)
    2165
    Adults (18-64 years)
    136
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Within this clinical trial 2921 patients were recruited in 17 participating countries with 239 active trial sites. Date of first enrolment: 2015-10-01 Date of last completed: 2024-10-31

    Pre-assignment
    Screening details
    		 Confirmation of the diagnosis by local pathologist and national reference pathologist;physical examination; medical history; laboratory analyses; imaging (PET); previous and concomitant disease status; fertility consideration; ECG

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TL-1
    Arm description
    		 stage IA/IB/IIA with ESR < 30 and without bulk. Two cycles of OEPA followed by early response assessment (ERA) including FDG-PET. Patients in TL-1 with a negative ERA PET scan are consolidated with one additional cycle of COPDAC-28. Patients in TL-1 with a positive PET scan at ERA will receive involved node radiotherapy to all initially involved sites.
    Arm type
    		 Standard for minor infestation

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5 mg/m2 i.v., capping dose 2 mg day 1 + 8 + 15

    Investigational medicinal product name
    Prednisone/Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg/m2/day p.o. divided into 3 doses day 1 – 15

    Investigational medicinal product name
    Doxorubicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg/m2 per 1-6 hour infusion day 1 + 15

    Investigational medicinal product name
    Etoposide/Etopophos
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg/m² Etoposide (NB: 142 mg Etoposide phosphate equals 125 mg etoposide); 2hrs infusion time day 1 – 5

    Arm title
    		 TL2+3 Rando AR
    Arm description
    		 This arm includes patients who show an adequate response at ERA. After initial staging and assignment to treatment level 2 or 3 patients have been randomised between DECOPDAC-21 or COPDAC-28. Patients assigned to TL-2 receive two cycles, patients assigend to TL-3 receive four cycles consolidation treatment according to the respective randomisation result.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5 mg/m2 i.v., capping dose 2 mg day 1 + 8 + 15

    Investigational medicinal product name
    Prednisone/Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg/m2/day p.o. divided into 3 doses day 1 – 15

    Investigational medicinal product name
    Doxorubicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg/m2 per 1-6 hour infusion day 1 + 15

    Investigational medicinal product name
    Etoposide/Etopophos
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg/m² Etoposide (NB: 142 mg Etoposide phosphate equals 125 mg etoposide); 2hrs infusion time day 1 – 5

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5 mg/m2 i.v., capping dose 2 mg day 1 + 8

    Investigational medicinal product name
    Prednisone/Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg/m2/day p.o. divided into 3 doses day 1 – 8, no capping dose

    Investigational medicinal product name
    Doxorubicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/m2 per 1-6 hour infusion day 1

    Investigational medicinal product name
    Etoposide/Etopophos
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg/m² Etoposide (NB: 142 mg Etoposide phosphate equals 125 mg etoposide); 2hrs infusion time day 1 – 5

    Investigational medicinal product name
    Dacarbazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    250 mg/m2 per 15 – 30 min. infusion day 1 – 3

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    625 mg/m2, 60-min. infusion day 1 and day 2 optional: concomitant intravenous hydration with glucose/saline solution at a rate of 3 l/m2 over 24 hours

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5 mg/m2 i.v., capping dose 2 mg day 1 + 8

    Investigational medicinal product name
    Prednisone/Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg/m2/day p.o. divided into 3 doses day 1 – 8, no capping dose

    Investigational medicinal product name
    Doxorubicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/m2 per 1-6 hour infusion day 1

    Investigational medicinal product name
    Etoposide/Etopophos
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg/m² Etoposide (NB: 142 mg Etoposide phosphate equals 125 mg etoposide); 2hrs infusion time day 1 – 5

    Investigational medicinal product name
    Dacarbazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    250 mg/m2 per 15 – 30 min. infusion day 1 – 3

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    625 mg/m2, 60-min. infusion day 1 and day 2 optional: concomitant intravenous hydration with glucose/saline solution at a rate of 3 l/m2 over 24 hours

    Arm title
    		 TL2+3 Rando IR
    Arm description
    		 This arm includes patients who show an insufficient response at ERA. After initial staging and assignment to treatment level 2 or 3 patients have been randomised between DECOPDAC-21 or COPDAC-28. Patients assigned to TL-2 receive two cycles, patients assigend to TL-3 receive four cycles consolidation treatment according to the respective randomisation result. These patients with a positive PET scan at ERA (IR) subsequently underwent additional radiotherapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5 mg/m2 i.v., capping dose 2 mg day 1 + 8 + 15

    Investigational medicinal product name
    Prednisone/Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg/m2/day p.o. divided into 3 doses day 1 – 15

    Investigational medicinal product name
    Doxorubicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg/m2 per 1-6 hour infusion day 1 + 15

    Investigational medicinal product name
    Etoposide/Etopophos
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg/m² Etoposide (NB: 142 mg Etoposide phosphate equals 125 mg etoposide); 2hrs infusion time day 1 – 5

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5 mg/m2 i.v., capping dose 2 mg day 1 + 8

    Investigational medicinal product name
    Prednisone/Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg/m2/day p.o. divided into 3 doses day 1 – 8, no capping dose

    Investigational medicinal product name
    Doxorubicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/m2 per 1-6 hour infusion day 1

    Investigational medicinal product name
    Etoposide/Etopophos
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg/m² Etoposide (NB: 142 mg Etoposide phosphate equals 125 mg etoposide); 2hrs infusion time day 1 – 5

    Investigational medicinal product name
    Dacarbazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    250 mg/m2 per 15 – 30 min. infusion day 1 – 3

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    625 mg/m2, 60-min. infusion day 1 and day 2 optional: concomitant intravenous hydration with glucose/saline solution at a rate of 3 l/m2 over 24 hours

    Number of subjects in period 1 [1]
    		TL-1 TL2+3 Rando AR TL2+3 Rando IR
    Started
    444
    1442
    802
    Completed
    442
    1442
    802
    Not completed
    2
    0
    0
         Consent withdrawn by subject
    1
    -
    -
         Physician decision
    1
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: See uploaded Trial Report (*.pdf)

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    TL-1
    Reporting group description
    		 stage IA/IB/IIA with ESR < 30 and without bulk. Two cycles of OEPA followed by early response assessment (ERA) including FDG-PET. Patients in TL-1 with a negative ERA PET scan are consolidated with one additional cycle of COPDAC-28. Patients in TL-1 with a positive PET scan at ERA will receive involved node radiotherapy to all initially involved sites.

    Reporting group title
    TL2+3 Rando AR
    Reporting group description
    		 This arm includes patients who show an adequate response at ERA. After initial staging and assignment to treatment level 2 or 3 patients have been randomised between DECOPDAC-21 or COPDAC-28. Patients assigned to TL-2 receive two cycles, patients assigend to TL-3 receive four cycles consolidation treatment according to the respective randomisation result.

    Reporting group title
    TL2+3 Rando IR
    Reporting group description
    		 This arm includes patients who show an insufficient response at ERA. After initial staging and assignment to treatment level 2 or 3 patients have been randomised between DECOPDAC-21 or COPDAC-28. Patients assigned to TL-2 receive two cycles, patients assigend to TL-3 receive four cycles consolidation treatment according to the respective randomisation result. These patients with a positive PET scan at ERA (IR) subsequently underwent additional radiotherapy.

    Primary: EFS

    		 Close Top of page
    End point title
    		 EFS [1]
    End point description
    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
    End point type
    Primary
    End point timeframe
    60 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See uploaded Trial Report (*pdf)
    End point values
    		 TL-1 TL2+3 Rando AR TL2+3 Rando IR
    Number of subjects analysed
    422
    1338
    678
    Units: whole
    422
    1338
    678
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    The observation period for adverse events begins at start of treatment and is restricted to events occurring within 3 months after the end of the trial treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: See uploaded Trial Report (*pdf)

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jul 2015
    Since the Coordinating investigator moved from Halle to another university (Justus Liebig University, Gießen) the Sponsor of the trial has changed. In addition, the study office will be located in Giessen from November 2015 on. Thus, all essential documents have to be changed. Also, one of the inclusion criteria regarding the upper limit of age in countries Australia and New Zealand has been adjusted. This change has been considered for the update of the synopsis to trial protocol, too.
    01 Jun 2016
    For all participating countries A) Relocation of Reference Centre from the University Hospital Halle to University Gießen/Marburg and study centre from Martin-Luther University Halle to Justus Liebig University Gießen; and clarification in PIC. B) Local contacts of the respective treating hospitals should be visualized on the letterhead of the PIC docs as long as country specific regulations allow this. C) Clarification in the protocol that the study group no longer differentiates between upper, middle and lower mediastinum, but only between upper and lower mediastinum. D) Clarification in the protocol that for Follow-up MRI i.v. contrast is not necessary. E) Clarification that in addition to photon radiotherapy also radiotherapy with protons may be used for radiotherapy of residual lymphoma in selected cases using the same dose and fractioning concepts and overall radiotherapy treatment time. (Only if country specific regulations consider the use of protons as standard of care as long as dose and fractioning dose do not differ from photon treatment.) F) Description in detail the process to organize quality control of radiotherapy within the appendix IV of the protocol. For Germany only A) Changes in two already approved country-specific side projects. B) Two new country-specific scientific side projects in Germany will be initiated. C) The study committee of the GPOH Hodgkin lymphoma study group elected Prof. Gattenlöhner as the newly acting coordinating reference pathologist in Germany.
    15 May 2017
    A)Change of DMC members B)Change of reference pathologist Norway C)Listing of Israelian reference pathologist D)Clarification on the term adverse reaction E)Correction of typing errors and wrong English wording, replacement of abbreviated Rt doses by actual RT doses throughout the text F)Correction of RT dose. The standard RT dose (protocol vs. flow diagram) G)Correction of orientation of figure 14 and15 H)Clarification on adequate contraception incl. correction in PIC docs I)Clarification on Regulations for Trial drug in Non-EU States J)Clarification on radomisation procedure and process K)Clarification regarding screening and pre-treatment investigations that are mandatory and those that are recommendations. L)Recognition of the different country specific requirements for parents providing consent for minors and use of full names. M)Clarification on indication for bone scan N)Implementation of guidance regarding vomiting after oral prednisone O)Clarification on frequency of recalculation body surface area P)Clarification on dose management in obese patients Q)Clarification that mesna in DECOPDAC may be used according to local guidelines incl. splitting the cyclophosphamide dose into two days R)Clarification on ECG if anthracycline dose exceeds 200 mg/m2 in DECOPDAC S)Clarification of the different RT strategies for E-lesion and dissiminated organ involvement T)Clarification of: Patient Withdrawal, Exclusion, Termination of individual trial treatment, Lost to follow-up U)Updated RT-Manual V)Clarification on exceptions from expedited SAE reporting W)Clarification regarding different national requirements for investigators X)Harmonisation of statements in protocol and monitoring Manual Y)Revision to sections III.1, III.2, III.3 and III.4 – to clarify which investigations are mandatory or recommendations Z)Clarification on imaging at suspected relapse AA)Clarification on maximum concentration of etoposide in solution
    31 Jul 2017
    1.1. Shifting the threshold for a negative LRA-PET (= end-of-treatment PET) from qPET 0.95 to qPET 1.3. 1.2. Documentation of patient data form pregnant partners of a trial subject or pregnant trial subjects and their newborns 1.3. Consideration of new information on Prednisolone in the patient information and the trial protocol 1.4. Update of patient information for country-specific side projects in Germany with respect to storage of blood samples. 1.5. Addition country-specific side projects (Italy and Netherlands), which may be open to other countries, if the necessary regulatory processes are fulfilled in the respective countries 1.6. Update of exceptions from expedited SAE reporting 1.7. Update of reference radiology in the central review board 1.8. Increasing the quality standard for reference pathology in Germany (accreditation according to DIN ISO 17020)
    01 Aug 2019
    1.1. Opening of the side project B-3 all EuroNet-PHL countries which are willing to participate in this project 1.2. Opening of the side project G “Gonadal function and fertility” in all EuroNet-PHL countries which are willing to participate in this project 1.3. Opening of the side project I “Immunodeficiency in Hodgkin Lymphoma” in all EuroNet-PHL countries which are willing to participate in this project 1.4. Opening of the Country-specific side project “Circulating cell-free DNA in classical Hodgkin Lymphoma in children adolescents and Young adults. The HOLY study.” 1.5. Detailed description of radiotherapy quality control 1.6. Implementation of the new data protection regulations in the German informed consent forms as well as in the English template for international use, if applicable in the respective country 1.7. Update of administrative data (contact data etc.)
    05 Sep 2020
    1.1. Early stop of patient registration 1.2. The final analysis will take place as soon as the median follow-up is 60 months (current internationally standard) and if 85% of the patients at least have reached 36 months follow-up at least. 1.3. Update of administrative data (contact data etc.)
    04 Jul 2024
    1.1. Earlier last patient last visit date 1.2. Final analysis planned for first quarter of 2025 1.1. Update of administrative data (contact data etc.)

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Dec 14 03:05:52 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA