Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents

March 30, 2026 updated by: University of Giessen

European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents

The EuroNet-PHL-C2 trial is an international, multicentre, randomised controlled trial with the aims to reduce the indication for radiotherapy in newly diagnosed patients with classical Hodgkin lymphoma without compromising cure rates and to investigate a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkin lymphoma to compensate for reduction in radiotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

EuroNet-PHL-C2 is a comprehensive treatment strategy for all first line classical Hodgkin Lymphoma (cHL) patients under 18 years (under 25 years in UK, Italy and France). The overall strategy is risk stratified (defining chemotherapy) and response adapted (defining radiotherapy) to tailor the amount of treatment to the individual patient and decrease long term complications.

  • Radiotherapy indication will be restricted. Patients with a negative PET scan after two cycles of OEPA chemotherapy (Early Response Assessment - ERA) will not receive radiotherapy. The threshold for negative PET scan at ERA shifts from the previously used Deauville 1 and 2 = negative (as in the C1 trial) to Deauville 1, 2 and 3 = negative, thereby increasing the number of negative patients without indication for RT.
  • Chemotherapy Randomisation

All intermediate (TL-2) and advanced stage (TL-3) patients will be randomised between respectively 2 or 4 standard COPDAC-28 or intensified DECOPDAC-21 consolidation chemotherapy cycles. To avoid delayed consolidation, randomisation has to be performed before ERA and as soon as the TL-assignment is confirmed by central review. Therefore two randomised sub-studies arise based on the ERA PET response:

Patients with adequate response at ERA do not receive radiotherapy - a randomised controlled chemotherapy comparison to show that intensified DECOPDAC-21 consolidation chemotherapy improves EFS as compared to standard COPDAC-28

Patients with inadequate response at ERA - a randomised controlled chemotherapy-radiotherapy comparison - to show that DECOPDAC-21 combined with radiotherapy restricted to sites that remain FDG-PET positive at the end of all chemotherapy (Late response assessment - LRA) has comparable EFS compared to COPDAC-28 plus standard involved node radiotherapy as in the C1 trial.

  • Risk stratification is refined Former treatment groups (TG) of the EuroNet-PHL-C1 trial are reassigned into treatment levels (TL) by shifting early stage patients (former TG-1) with risk factors into TL-2.
  • Semi-quantitative 'qPET' Results of semi-quantitative qPET are formally integrated into the response assessment.

Study Type

Interventional

Enrollment (Actual)

2921

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Victoria Park, Australia, 3052
        • Royal Children's Hospital and Monash Medical Centre Royal Children's Hospital
  • Austria
      • Vienna, Austria, 1090
        • St. Anna Kinderspital
  • Belgium
      • Leuven, Belgium, 3000
        • Paediatric haemato-oncology, University Hospitals of Leuven
  • Czechia
      • Prague, Czechia, 15006
        • Dpt. of Pediatric Hematology and Oncology, Faculty Hospital Motol
  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Pediatric Hematology/Oncology (5054) The Child and Youth Clinic, University Hospital of Copenhagen
  • France
      • Paris, France, 75571
        • Service d'Oncohématologie, Hopital d'Ènfants Armand Trousseau
  • Germany
      • Giessen, Germany, 35392
        • Justus Liebig University of Giessen
  • Ireland
      • Dublin, Ireland, 12
        • Our Lady's Children's Hospital, Crumlin
  • Israel
      • Petah Tikva, Israel, 49202
        • Tel Aviv University Schneider Children's Medical Center of Israel The Rina Zaizov Pediatric Hematology Oncology Division
  • Italy
      • Aviano, Italy, 33081
        • Pediatric Radiotherapy and Youth Area Unit C.R.O. - Centro di Riferimento Oncologico IRCCS
  • Netherlands
      • Utrecht, Netherlands, 3508
        • Princess Máxima Center for Pediatric Oncology
  • New Zealand
      • Auckland, New Zealand, 1142
        • Starship Blood and Cancer Centre, Starship Children's Hospital
  • Norway
      • Oslo, Norway, 0424
        • Department of Medical Oncology Oslo University Hospital
  • Poland
      • Krakow, Poland, 30-663
        • Head of Department of Pediatric Oncology and Hematology, Polish-American Pediatric Institute, Jagiellonian University Medical Faculty
  • Slovakia
      • Bratislava, Slovakia, 83340
        • Clinic of Pediatric Oncology University Children's Hospital
  • Spain
      • Seville, Spain, 41071
        • Sección de Onco-Hematología Pediátrica Hospital Universitario Virgen Macarena y Virgen del Rocío
  • Sweden
      • Uppsala, Sweden, 75185
        • Pediatric Hematology & Oncology Children´s University Hospital
  • Switzerland
      • Lausanne, Switzerland, 1011
        • CHUV - Centre Hospitalier Universitaire Vaudois = LS, Départment femme - meré - enfant, Service de pédiatrie, Unité d'hématologie-oncologie pédiatrique
  • United Kingdom
      • London, United Kingdom, NW1 2PG
        • University College London Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: COPDAC-28
cyclophosphamide, vincristine, prednisone, dacarbazine; cyclophosphamide 500 mg/m2, per infusion on day 1 + 8; vincristine 1.5 mg/m2 intravenously (capping dose 2 mg) on day 1 + 8 and prednisone 40 mg/m2/day by mouth divided into 3 doses (capping dose 80 mg/day) on day 1 - 15 and dacarbazine 250 mg/m2 infusion on day 1 - 3
Drug: cyclophosphamide, vincristine, prednisone, dacarbazine
28-day chemotherapy cycle
Other Names:
  • CYC, VCR, PRED, DTIC
Experimental: DECOPDAC-21
patients with intermediate and advanced stages will be randomized after the induction therapy to receive either COPDAC-28 standard consolidation or the intensified DECOPDAC-21. cyclophosphamide dose augmented to 625 mg/m2 and adminstered per infusion on day 1 and day 2; vincristine dose not changed; prednisone 40 mg/m2/day by mouth on day 1 - 8 (no capping dose prescribed), i.e. dose-reduction; dacarbazine dose not changed; etoposide infusion100 mg/m2/day on day 1 - 3 and doxorubicine 25 mg/m2 per infusion on day 1as additional drugs in comparison to active comparator; cycle is administered as 21 days instead of 28 days-cycle for intensification
Drug: cyclo, vcr, pred, dacarb,etop and doxo
21-day chemotherapy cycle
Other Names:
  • CYC, VCR, PRED, DTIC, ETO, DOXO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: 5 years
Time from treatment start until relapse/progression, secondary malignancy or death
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Time from treatment start until death
5 years
Progression-free survival
Time Frame: 5 years
Time from treatment start until relapse/progression or death
5 years
CTC (common toxicity criteria) grading during any individual treatment element including assessment of osteonecrosis
Time Frame: 5 years
Toxicity assessment according to CTCAE v4.0
5 years
Time from day of PET imaging until decision on response category at ERA or LRA, respectively
Time Frame: 5 years
Quality of Imaging (CT,MRI and PET-CT) acquisition,
5 years
Time from last day of chemotherapy to first day of radiotherapy in patients with radiotherapy indication
Time Frame: 5 years
Quality of chemo-and radiotherapy delivery
5 years
Time from last dose of prednisone/prednisolone in OEPA to start of the first consolidation cycle
Time Frame: 5 years
Quality of chemotherapy delivery
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Collaborators

Deutsche Krebshilfe e.V., Bonn (Germany)
Euronet Worldwide

Investigators

  • Study Chair: Dieter Koerholz, MD, Justus-Liebig University of Giessen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimated)

February 18, 2016

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EuroNet-PHL-C2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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