Clinical trial · Interventional
Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
NCT02684708CI-TRIAL-00106919completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide, vincristine, prednisone, dacarbazine | Drug | — | UNRESOLVED |
| cyclo, vcr, pred, dacarb,etop and doxo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- COPDAC-28
- description
- 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
- interventionNames
- Drug: cyclophosphamide, vincristine, prednisone, dacarbazine
- type
- EXPERIMENTAL
- label
- DECOPDAC-21
- description
- 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
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 25 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDPabari 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
- DERIVEDDrechsel 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