Classical Hodgkin LymphomaPhase 3NCT02684708
Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
A Phase 3 study testing cyclophosphamide, vincristine, prednisone, dacarbazine and cyclo, vcr, pred, dacarb,etop and doxo in people with Classical Hodgkin Lymphoma, run by University of Giessen at 19 sites in 19 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Classical Hodgkin Lymphoma
- What is being tested?
- cyclophosphamide, vincristine, prednisone, dacarbazine and cyclo, vcr, pred, dacarb,etop and doxo
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,921 participants
- Where
- 19 sitesin 19 countries
- Study dates
- 1 Oct 2015to 31 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
19 sites in 19 countries.
19 sites in 19 countries
Australia1 site
Royal Children's Hospital and Monash Medical Centre Royal Children's Hospital
Victoria Park, 3052
Belgium1 site
Paediatric haemato-oncology, University Hospitals of Leuven
Leuven, 3000
Czechia1 site
Dpt. of Pediatric Hematology and Oncology, Faculty Hospital Motol
Prague, 15006
Denmark1 site
Department of Pediatric Hematology/Oncology (5054) The Child and Youth Clinic, University Hospital of Copenhagen
Copenhagen, 2100
France1 site
Service d'Oncohématologie, Hopital d'Ènfants Armand Trousseau
Paris, 75571
Israel1 site
Tel Aviv University Schneider Children's Medical Center of Israel The Rina Zaizov Pediatric Hematology Oncology Division
Petah Tikva, 49202
Italy1 site
Pediatric Radiotherapy and Youth Area Unit C.R.O. - Centro di Riferimento Oncologico IRCCS
Aviano, 33081
Netherlands1 site
Princess Máxima Center for pediatric oncology
Utrecht, 3508
New Zealand1 site
Starship Blood and Cancer Centre, Starship Children's Hospital
Auckland, 1142
Norway1 site
Department of Medical Oncology Oslo University Hospital
Oslo, 0424
Poland1 site
Head of Department of Pediatric Oncology and Hematology, Polish-American Pediatric Institute, Jagiellonian University Medical Faculty
Krakow, 30-663
Slovakia1 site
Clinic of Pediatric Oncology University Children's Hospital
Bratislava, 83340
Spain1 site
Sección de Onco-Hematología Pediátrica Hospital Universitario Virgen Macarena y Virgen del Rocío
Seville, 41071
Sweden1 site
Pediatric Hematology & Oncology Children´s University Hospital
Uppsala, 75185
Switzerland1 site
CHUV - Centre Hospitalier Universitaire Vaudois = LS, Départment femme - meré - enfant, Service de pédiatrie, Unité d'hématologie-oncologie pédiatrique
Lausanne, 1011
United Kingdom1 site
University College London Hospitals
London, NW1 2PG
About this study
Official title: 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.
Read the 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.
- Conditions
- Classical Hodgkin Lymphoma
- Being tested
- cyclophosphamide, vincristine, prednisone, dacarbazine, cyclo, vcr, pred, dacarb,etop and doxo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamide, vincristine, prednisone, dacarbazineDrug
Also called CYC, VCR, PRED, DTIC
28-day chemotherapy cycle
cyclo, vcr, pred, dacarb,etop and doxoDrug
Also called CYC, VCR, PRED, DTIC, ETO, DOXO
21-day chemotherapy cycle
| Study group | Role | What they receive |
|---|---|---|
| COPDAC-28 | Active comparator | 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 Receives: Drug: cyclophosphamide, vincristine, prednisone, dacarbazine |
| DECOPDAC-21 | Experimental | 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 Receives: Drug: cyclo, vcr, pred, dacarb,etop and doxo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Time from treatment start until relapse/progression, secondary malignancy or death
Measured: 5 years
Secondary outcomes (6)
Overall survival
Time from treatment start until death
Measured: 5 years
Progression-free survival
Time from treatment start until relapse/progression or death
Measured: 5 years
CTC (common toxicity criteria) grading during any individual treatment element including assessment of osteonecrosis
Toxicity assessment according to CTCAE v4.0
Measured: 5 years
Time from day of PET imaging until decision on response category at ERA or LRA, respectively
Quality of Imaging (CT,MRI and PET-CT) acquisition,
Measured: 5 years
Time from last day of chemotherapy to first day of radiotherapy in patients with radiotherapy indication
Quality of chemo-and radiotherapy delivery
Measured: 5 years
Time from last dose of prednisone/prednisolone in OEPA to start of the first consolidation cycle
Quality of chemotherapy delivery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start1 Oct 2015
- Primary completion31 Oct 2024
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,921 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), Euronet Worldwide
- Responsible party
- Sponsor
- Investigators
- Dieter Koerholz, MD, Study chair, Justus-Liebig University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684708
- Sponsor's protocol ID
- EuroNet-PHL-C2
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2015
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pabari R, McCarten K, Flerlage J, Lai H, Mauz-Korholz C, Dieckmann K, Palese M, Kaste S, Castellino SM, Kelly KM, Stoevesandt D, Kurch L. Hodgkin lymphoma involving the extra-axial CNS: an AHOD1331, PHL-C1, and PHL-C2 report from the COG and EuroNet-PHL. Blood Adv. 2024 Sep 24;8(18):4856-4865. doi: 10.1182/bloodadvances.2023012346.
PubMed 39058968Drechsel KCE, Pilon MCF, Stoutjesdijk F, Meivis S, Schoonmade LJ, Wallace WHB, van Dulmen-den Broeder E, Beishuizen A, Kaspers GJL, Broer SL, Veening MA. Reproductive ability in survivors of childhood, adolescent, and young adult Hodgkin lymphoma: a review. Hum Reprod Update. 2023 Jul 5;29(4):486-517. doi: 10.1093/humupd/dmad002.
PubMed 36779325
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
- ClinicalTrials.gov ID
- NCT02684708
- Acronym / sponsor ID
- EuroNet-PHL-C2
- Conditions
- Classical Hodgkin Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,921 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), Euronet Worldwide
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPDAC-28 | Active comparator | Drug: cyclophosphamide, vincristine, prednisone, dacarbazinecyclophosphamide, 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 |
| DECOPDAC-21 | Experimental | Drug: cyclo, vcr, pred, dacarb,etop and doxopatients 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 |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cyclophosphamide, vincristine, prednisone, dacarbazineAlso: CYC, VCR, PRED, DTIC28-day chemotherapy cycle | Drug | COPDAC-28 |
| cyclo, vcr, pred, dacarb,etop and doxoAlso: CYC, VCR, PRED, DTIC, ETO, DOXO21-day chemotherapy cycle | Drug | DECOPDAC-21 |
Primary outcome
Event-free survival
Time frame: 5 years
Time from treatment start until relapse/progression, secondary malignancy or death
6 secondary outcomes
Overall survival
Time frame: 5 years
Progression-free survival
Time frame: 5 years
CTC (common toxicity criteria) grading during any individual treatment element including assessment of osteonecrosis
Time frame: 5 years
Time from day of PET imaging until decision on response category at ERA or LRA, respectively
Time frame: 5 years
Time from last day of chemotherapy to first day of radiotherapy in patients with radiotherapy indication
Time frame: 5 years
Time from last dose of prednisone/prednisolone in OEPA to start of the first consolidation cycle
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Derived from this study: PubMed 39058968Pabari R, McCarten K, Flerlage J, Lai H, Mauz-Korholz C, Dieckmann K, Palese M, Kaste S, Castellino SM, Kelly KM, Stoevesandt D, Kurch L. Hodgkin lymphoma involving the extra-axial CNS: an AHOD1331, PHL-C1, and PHL-C2 report from the COG and EuroNet-PHL. Blood Adv. 2024 Sep 24;8(18):4856-4865. doi: 10.1182/bloodadvances.2023012346.
- Derived from this study: PubMed 36779325Drechsel KCE, Pilon MCF, Stoutjesdijk F, Meivis S, Schoonmade LJ, Wallace WHB, van Dulmen-den Broeder E, Beishuizen A, Kaspers GJL, Broer SL, Veening MA. Reproductive ability in survivors of childhood, adolescent, and young adult Hodgkin lymphoma: a review. Hum Reprod Update. 2023 Jul 5;29(4):486-517. doi: 10.1093/humupd/dmad002.
- Hodgkin lymphoma treatment in children and adolescentsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Koerholz, MD study chair
Justus-Liebig University of Giessen
19 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyclophosphamide, vincristine, prednisone, dacarbazine and cyclo, vcr, pred, dacarb,etop and doxo in people with Classical Hodgkin Lymphoma, run by University of Giessen at 19 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia, Austria, Belgium, Czechia, Denmark and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02684708, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.