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    Clinical Trial Results:
    EuroNet-Paediatric Hodgkin’s Lymphoma Group First international Inter-Group Study for nodular lymphocyte-predominant Hodgkin’s Lymphoma in Children and Adolescents

    Summary
    EudraCT number
    		 2007-004092-19
    Trial protocol
    		 DE   CZ   AT   NL   GB   FR  
    Global end of trial date
    31 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Dec 2025
    First version publication date
    19 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EuroNet-PHL-LP1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Martin-Luther-University Halle-Wittenberg
    Sponsor organisation address
    Magdeburger Str. 27, Halle/Saale, Germany,
    Public contact
    Zentrum für Kinderheilkunde und Jugendmedizin, Universitätsklinikum Giessen udn Marburg GmbH, Standort Giessen, 0049 641 985-43420, dieter.koerholz@paediat.med.uni-giessen.de
    Scientific contact
    Zentrum für Kinderheilkunde und Jugendmedizin, Universitätsklinikum Giessen udn Marburg GmbH, Standort Giessen, 0049 641 985-43420, 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
    10 Feb 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Building on the experience of the European PHL study groups since 1978, first line therapy for childhood nodular lymphocyte-predominant Hodgkin’s lymphoma shall be further optimised to avoid over-treatment and decrease long-term complications.  Surgery alone for patients with stage IA disease and complete resection.  Low intensity chemotherapy with CVP (Cyclophosphamide, Vincristine and Prednisolone (or Prednisone)) for patients with stage IA and incomplete resection or stage IIA disease Patients with complete resection group: Statistically estimate the five year event free survival rate with meaningful precision and show it is above 50%. Patients with residual disease receiving 3 CVP: Statistically estimate the 5 year Event free survival rate in all patients receiving CVP chemotherapy.
    Protection of trial subjects
    Patients were monitored by the medical staff with regard to safety
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 16
    Country: Number of subjects enrolled
    United Kingdom: 61
    Country: Number of subjects enrolled
    Austria: 13
    Country: Number of subjects enrolled
    Czechia: 7
    Country: Number of subjects enrolled
    France: 41
    Country: Number of subjects enrolled
    Germany: 66
    Country: Number of subjects enrolled
    Italy: 22
    Country: Number of subjects enrolled
    Switzerland: 11
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    247
    EEA total number of subjects
    165
    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)
    118
    Adolescents (12-17 years)
    129
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Within this clinical trial, 270 patients were recruited in nine participating countries with 92 active trial sites. Three patients withdrew before start of treatment, leaving 267 for analysis. The list of active trial centres that have been recruiting study patients is attached to this report.

    Pre-assignment
    Screening details
    		 After local staging and registration patients central review staging has been performed. Follwoing this, patienst ha sbeen assigned to the 3 substudies.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Surgery only - watch and wait
    Arm description
    		 The study population of substudy 1 comprises all chemotherapy naive stage IA/IIA patients that either were already in complete resection after the diagnostic biopsy or in whom additional surgery was successful. 6 patients Relapse after surgery alone have been assigned to CVP
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 CVP with partially PET-based RA
    Arm description
    		 The study population of substudy 2 comprises all all chemotherapy naive stage IA/IIA patients with residual disease in whom additional surgery was not successful or deemed unfeasible. Patients who relapsed within the substudy 1 were allowed to enter substudy 2 with a second registration. The definition of good response in the CVP substudy was initially partially based on PET: Patients have a good response if they are • in overall CR or • CRu and all initially involved regions are • PET-negative or • PET-unclear and either in local CR or undetectable
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Day 1 By slow bolus into established i.v. line or by intravenous infusion over 1 hour. By i.v. infusion in Glucose 5%, Sodium chloride 0.9% or Glucose/saline. Dosage: 500 mg/m²

    Investigational medicinal product name
    Prednisone/Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Day 1-8 40 mg/m²/day Prednisone (Tablet); Prednisolone (infusion)

    Investigational medicinal product name
    Vinblastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Injection
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    Day 1 and day 8 By bolus injection or into the tubing of a fast running intravenous infusion. Dosage: 6 mg/m² i.v., capping dose 10 mg (single dose); used only as a substitute if acute vincristine toxicity occurs

    Arm title
    		 CVP without PET RA
    Arm description
    		 The apparently low response rate detected in an interim analysis may have been a matter of definition and due to the application of overly strict response criteria (using PET). Most CRu patients with still visible FDG-PET uptake would have had a low relapse rate even without additional treatment, as suggested by data from a publication. Based on these interim results, a change in strategy was decided upon and PET-based RA was abandoned.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Day 1 By slow bolus into established i.v. line or by intravenous infusion over 1 hour. By i.v. infusion in Glucose 5%, Sodium chloride 0.9% or Glucose/saline. Dosage: 500 mg/m²

    Investigational medicinal product name
    Prednisone/Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Day 1-8 40 mg/m²/day Prednisone (Tablet); Prednisolone (infusion)

    Investigational medicinal product name
    Vinblastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Injection
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    Day 1 and day 8 By bolus injection or into the tubing of a fast running intravenous infusion. Dosage: 6 mg/m² i.v., capping dose 10 mg (single dose); used only as a substitute if acute vincristine toxicity occurs

    Number of subjects in period 1
    		Surgery only - watch and wait CVP with partially PET-based RA CVP without PET RA
    Started
    87
    82
    78
    Completed
    87
    82
    78

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Surgery only - watch and wait
    Reporting group description
    		 The study population of substudy 1 comprises all chemotherapy naive stage IA/IIA patients that either were already in complete resection after the diagnostic biopsy or in whom additional surgery was successful. 6 patients Relapse after surgery alone have been assigned to CVP

    Reporting group title
    CVP with partially PET-based RA
    Reporting group description
    		 The study population of substudy 2 comprises all all chemotherapy naive stage IA/IIA patients with residual disease in whom additional surgery was not successful or deemed unfeasible. Patients who relapsed within the substudy 1 were allowed to enter substudy 2 with a second registration. The definition of good response in the CVP substudy was initially partially based on PET: Patients have a good response if they are • in overall CR or • CRu and all initially involved regions are • PET-negative or • PET-unclear and either in local CR or undetectable

    Reporting group title
    CVP without PET RA
    Reporting group description
    		 The apparently low response rate detected in an interim analysis may have been a matter of definition and due to the application of overly strict response criteria (using PET). Most CRu patients with still visible FDG-PET uptake would have had a low relapse rate even without additional treatment, as suggested by data from a publication. Based on these interim results, a change in strategy was decided upon and PET-based RA was abandoned.

    Primary: Primary: EFS

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    End point title
    		 Primary: EFS [1]
    End point description
    EFS as defined by time from registration until the first of the following events: • Additional treatment for Hodgkin’s Lymphoma • progression/relapse of disease • occurrence of a secondary • death by 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
    		 Surgery only - watch and wait CVP with partially PET-based RA CVP without PET RA
    Number of subjects analysed
    87
    82
    78
    Units: Whole
        number (not applicable)
    79.5
    56.4
    64.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Reporting of adverse events is restricted to events occurring within 3 months after the end of the study 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: 0%
    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

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Nov 2009
    Minor; Clarification of study medication in the protocol synopsis (typing error); Change of contact information
    29 Jun 2011
    Minor; Updating contact information; Mentioning the investigational medical products in the protocol synopsis; Adjustment of data to effective trial start in Germany; Clarification of further follow-up in patients without good response, after they go off protocol; Clarification of what are the IMPs and determination of body surface area; Deletion of the chemotherapy drug monographs section from protocol; clarifications in language
    22 Dec 2011
    Minor: Clarification for logistics of central review and data storage of CT/MRI images and FDG-PET data sets in central review board; clarification of contact details
    04 Nov 2014
    Based on the interim results, change in strategy after the trial enrolment stops in Germany in October 2014. Starting in November 2014 the trial will continue for another four years in all participating countries, except Germany (for insurance reasons), applying new response criteria (CR/CRu by CT/MRI as described in the EuroNet-PHL-LP1 protocol) similar to those used in Shankar 2012. Set-up German specific investigation of gene expression profile.
    26 Aug 2015
    Minor: Patients being enrolled onto the trial in all participating countries, except for France, were asked to agree to central clinical review of staging and response assessment. Change of contact data.

    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
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    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.

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