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| ID | Type | Description | Link |
|---|---|---|---|
| EURONET-PHL-C1 | |||
| EU-20703 | |||
| EUDRACT-2006-000995-33 | |||
| CCLG-HD-2007-10 |
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| Name | Class |
|---|---|
| Deutsche Krebshilfe e.V., Bonn (Germany) | OTHER |
| Euronet Worldwide | OTHER |
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, controlled, parallel-group, open-label, multicenter study. Patients are stratified according to staging and response assessment (central vs local) and disease stage (IA/B or IIA [first-line treatment group 1] vs I_EA/B, II_EA, IIB, or IIIA [first-line treatment group 2] vs II_EB, III_E A/B, IIIB, or IVA/B [first-line treatment group 3]).
Treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity. Patients are assessed by fludeoxyglucose F 18 positron emission tomography (^18FDG-PET) scan. Patients with inadequate response undergo radiotherapy within 35 days after completion of OEPA.
First-line treatment group 2: Patients receive OEPA as in group 1. After completion of OEPA, patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity. Patients are assessed by ^18FDG-PET scan. Patients with an inadequate response undergo radiotherapy within 35 days after completion of COPP or COPDAC.
First-line treatment group 3: Patients receive OEPA as in group 1. After completion of OEPA, patients are randomized to 1 of 2 treatment arms.
Patients with biopsy-confirmed disease progression OR relapse after first-line treatment on this study or on protocols DAL-HD 90, GPOH-HD 95, GPOHHD 2002 Pilot, or similar treatment proceed to second-line therapy. Patients are stratified according to relapse/progression status (late relapse from first-line treatment group 1 [second-line treatment group 1] vs early relapse from first-line treatment groups 1, 2, or 3 or late relapse from first-line treatment groups 2 or 3 [second-line treatment group 2] vs disease progression [second-line treatment group 3]). Patients undergo a ^18FDG-PET scan prior to beginning second-line therapy.
After chemotherapy treatment, patients undergo radiotherapy.
After chemotherapy, patients with an adequate response undergo radiotherapy. Patients with an inadequate response undergo high-dose chemotherapy comprising carmustine IV over 1-2 hours on day -7, etoposide IV and cytarabine IV over 30 minutes twice daily on days -6 to -3, and melphalan IV over 1½ hours on day -2. Patients then undergo autologous hematopoietic stem cell transplantation (HSCT).
Patients undergo a ^18FDG-PET scan on day 50-54. Patients with ^18FDG-PET scan positive disease undergo radiotherapy.
Patients undergo a ^18FDG-PET scan on day 50-54. Patients with ^18FDG-PET scan positive disease undergo radiotherapy.
After completion of study therapy, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 2,150 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPP | Active Comparator | procarbazine-containing consolidation chemotherapy arm |
|
| COPDAC | Experimental | procarbazine-free consolidation chemotherapy arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug | drug is used in first line treatment in combination (COPP or COPDAC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years | |
| Progression-free survival | 5 years | |
| CTC (Common toxicity criteria) toxicity levels of therapy elements |
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DISEASE CHARACTERISTICS:
Histologically confirmed classical Hodgkin's lymphoma
No prior treatment for Hodgkin's lymphoma except for recommended pre-phase therapy for a large mediastinal tumor
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Koerholz, MD | Martin-Luther-Universität Halle-Wittenberg | Study Chair |
| W. Hamish Wallace, MD | Royal Hospital for Sick Children | Principal Investigator |
| Judith Landman-Parker, MD | Hopital d'Enfants Trousseau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinikum Giessen-Marburg | Giessen | D-35385 | Germany | |||
| Royal Hospital for Sick Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40639904 | Derived | Kurch L, Landman-Parker J, Georgi TW, Attarbaschi A, Balwierz W, Beishuizen A, Braun M, Cepelova M, Ceppi F, Claviez A, Daw S, Dieckmann K, Fernandez-Teijeiro A, Flerlage JE, Fossa A, Hjalgrim LL, Hraskova A, Karlen J, Klekawka T, Leblanc T, Montravers F, Lopci E, Mascarin M, Pears J, Pelz T, Prelog T, Rohde M, Sabri O, Steglich J, Stoevesandt D, Uytterbroeck A, Vordermark D, Wallace WH, Korholz D, Mauz-Korholz C, Kluge R, Hasenclever D. Quantitative Deauville Scoring to Uncover Prognostic Information from 18F-FDG PET-Based Response Assessment: Data from the EuroNet-PHL-C1 Trial. J Nucl Med. 2025 Sep 2;66(9):1331-1337. doi: 10.2967/jnumed.125.269603. | |
| 39745682 |
| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D003606 | Dacarbazine |
| D011239 | Prednisolone |
| D011241 | Prednisone |
| D011344 | Procarbazine |
| D014750 | Vincristine |
| D019788 | Fluorodeoxyglucose F18 |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
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| dacarbazine | Drug | drug is used in first line treatment in combination (COPDAC) |
|
|
| prednisolone | Drug | drug is used in first line treatment in combination (OEPA, COPP or COPDAC) |
|
| prednisone | Drug | drug is used in first line treatment in combination (OEPA, COPP or COPDAC) |
|
| procarbazine hydrochloride | Drug | drug is used in first line treatment in combination (COPP) |
|
| vincristine sulfate | Drug | drug is used in first line treatment in combination (OEPA, COPP or COPDAC) |
|
|
| fludeoxyglucose F 18 | Radiation | used as a diagnostic marker for metabolically active tumour at staging and response assessment |
|
| radiation therapy | Radiation | part of combination treatment (combined modality between chemo- and radiotherapy) |
|
|
| 5 years |
| Evidence of male infertility score | 5 years |
| Evidence of female infertility score | 5 years |
| Long-term consequences (e.g., premature menopause, secondary cancer) | 5 years |
| Edinburgh |
| Scotland |
| EH9 1LF |
| United Kingdom |
| Derived |
| Daw S, Claviez A, Kurch L, Stoevesandt D, Attarbaschi A, Balwierz W, Beishuizen A, Cepelova M, Ceppi F, Fernandez-Teijeiro A, Fossa A, Georgi TW, Hjalgrim LL, Hraskova A, Leblanc T, Mascarin M, Pears J, Landman-Parker J, Prelog T, Klapper W, Ramsay A, Kluge R, Dieckmann K, Pelz T, Vordermark D, Korholz D, Hasenclever D, Mauz-Korholz C. Transplant and Nontransplant Salvage Therapy in Pediatric Relapsed or Refractory Hodgkin Lymphoma: The EuroNet-PHL-R1 Phase 3 Nonrandomized Clinical Trial. JAMA Oncol. 2025 Mar 1;11(3):258-267. doi: 10.1001/jamaoncol.2024.5636. |
| 39058968 | Derived | 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. |
| 37505794 | Derived | Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28. |
| 36858722 | Derived | Mauz-Korholz C, Landman-Parker J, Fernandez-Teijeiro A, Attarbaschi A, Balwierz W, Bartelt JM, Beishuizen A, Boudjemaa S, Cepelova M, Ceppi F, Claviez A, Daw S, Dieckmann K, Fossa A, Gattenlohner S, Georgi T, Hjalgrim LL, Hraskova A, Karlen J, Kurch L, Leblanc T, Mann G, Montravers F, Pears J, Pelz T, Rajic V, Ramsay AD, Stoevesandt D, Uyttebroeck A, Vordermark D, Korholz D, Hasenclever D, Wallace WH, Kluge R. Response-adapted omission of radiotherapy in children and adolescents with early-stage classical Hodgkin lymphoma and an adequate response to vincristine, etoposide, prednisone, and doxorubicin (EuroNet-PHL-C1): a titration study. Lancet Oncol. 2023 Mar;24(3):252-261. doi: 10.1016/S1470-2045(23)00019-0. |
| 34895479 | Derived | Mauz-Korholz C, Landman-Parker J, Balwierz W, Ammann RA, Anderson RA, Attarbaschi A, Bartelt JM, Beishuizen A, Boudjemaa S, Cepelova M, Claviez A, Daw S, Dieckmann K, Fernandez-Teijeiro A, Fossa A, Gattenlohner S, Georgi T, Hjalgrim LL, Hraskova A, Karlen J, Kluge R, Kurch L, Leblanc T, Mann G, Montravers F, Pears J, Pelz T, Rajic V, Ramsay AD, Stoevesandt D, Uyttebroeck A, Vordermark D, Korholz D, Hasenclever D, Wallace WH. Response-adapted omission of radiotherapy and comparison of consolidation chemotherapy in children and adolescents with intermediate-stage and advanced-stage classical Hodgkin lymphoma (EuroNet-PHL-C1): a titration study with an open-label, embedded, multinational, non-inferiority, randomised controlled trial. Lancet Oncol. 2022 Jan;23(1):125-137. doi: 10.1016/S1470-2045(21)00470-8. Epub 2021 Dec 9. |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |