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

NCT02684708 | Completed Phase 3 DMC

• 1 other identifier: EuroNet-PHL-C2
• Study Type: interventional
• Target: 2,921
• Locations: 18 countries
• Sites: 18

Brief 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 advanced classical Hodgkin lymphoma to compensate for reduction in radiotherapy.

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  Time from treatment start until relapse/progression, secondary malignancy or death

  5 years

Secondary Outcomes (6)

• Overall survival

  5 years

• Progression-free survival

  5 years

• CTC (common toxicity criteria) grading during any individual treatment element including assessment of osteonecrosis

  5 years

• Time from day of PET imaging until decision on response category at ERA or LRA, respectively

  5 years

• Time from last day of chemotherapy to first day of radiotherapy in patients with radiotherapy indication

  5 years

Study Arms (2)

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

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

Drug: cyclo, vcr, pred, dacarb,etop and doxo

Interventions

cyclo, vcr, pred, dacarb,etop and doxo DRUG

21-day chemotherapy cycle

Also known as: CYC, VCR, PRED, DTIC, ETO, DOXO

DECOPDAC-21

cyclophosphamide, vincristine, prednisone, dacarbazine DRUG

28-day chemotherapy cycle

Also known as: CYC, VCR, PRED, DTIC

COPDAC-28

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Giessen: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator
• Euronet Worldwide: collaborator

Study Sites (19)

Royal Children's Hospital and Monash Medical Centre Royal Children's Hospital

Victoria Park, 3052, Australia

Location

St. Anna Kinderspital

Vienna, 1090, Austria

Location

Paediatric haemato-oncology, University Hospitals of Leuven

Leuven, 3000, Belgium

Location

Dpt. of Pediatric Hematology and Oncology, Faculty Hospital Motol

Prague, 15006, Czechia

Location

Department of Pediatric Hematology/Oncology (5054) The Child and Youth Clinic, University Hospital of Copenhagen

Copenhagen, 2100, Denmark

Location

Service d'Oncohématologie, Hopital d'Ènfants Armand Trousseau

Paris, 75571, France

Location

Justus Liebig University of Giessen

Giessen, 35392, Germany

Location

Our Lady's Children's Hospital, Crumlin

Dublin, 12, Ireland

Location

Tel Aviv University Schneider Children's Medical Center of Israel The Rina Zaizov Pediatric Hematology Oncology Division

Petah Tikva, 49202, Israel

Location

Pediatric Radiotherapy and Youth Area Unit C.R.O. - Centro di Riferimento Oncologico IRCCS

Aviano, 33081, Italy

Location

Princess Máxima Center for pediatric oncology

Utrecht, 3508, Netherlands

Location

Starship Blood and Cancer Centre, Starship Children's Hospital

Auckland, 1142, New Zealand

Location

Department of Medical Oncology Oslo University Hospital

Oslo, 0424, Norway

Location

Head of Department of Pediatric Oncology and Hematology, Polish-American Pediatric Institute, Jagiellonian University Medical Faculty

Krakow, 30-663, Poland

Location

Clinic of Pediatric Oncology University Children's Hospital

Bratislava, 83340, Slovakia

Location

Sección de Onco-Hematología Pediátrica Hospital Universitario Virgen Macarena y Virgen del Rocío

Seville, 41071, Spain

Location

Pediatric Hematology & Oncology Children´s University Hospital

Uppsala, 75185, Sweden

Location

CHUV - Centre Hospitalier Universitaire Vaudois = LS, Départment femme - meré - enfant, Service de pédiatrie, Unité d'hématologie-oncologie pédiatrique

Lausanne, 1011, Switzerland

Location

University College London Hospitals

London, NW1 2PG, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39058968 DERIVED

• Drechsel 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.

  PMID: 36779325 DERIVED

Related Links

• Hodgkin lymphoma treatment in children and adolescents

MeSH Terms

Interventions

Cyclophosphamide; Vincristine; Prednisone; Dacarbazine; prednylidene

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Dieter Koerholz, MD

  Justus-Liebig University of Giessen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: February 18, 2016
• Study Start: October 1, 2015
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); NL (1); AU (1); BE (1); SE (1); PL (1); GB (1); IL (1); FR (1); CZ (1); IT (1); IE (1); SL (1); ES (1); CH (1); DK (1); DE (1); NO (1)