drugset / Trial / NCT00433459
Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma
Phase 3
Completed
2134 enrolled
Christine Mauz-Körholz
Deutsche Krebshilfe e.V., Bonn (Germany) · collabEuronet Worldwide · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2007-01
- Primary completion
- 2013-01
- Completion
- 2013-01
Outcome
Mixed primary results
paper In 440 of 713 patients in the intention-to-treat group who had an adequate response and did not receive radiotherapy, 5-year event-free survival was 86·5% PMID 36858722 ↗
paper which was less than the 90% target rate. PMID 36858722 ↗
paper In patients who responded adequately, event-free survival rates at 5 years were 90·1% PMID 34895479 ↗
paper The primary objectives were maintaining 90% event-free survival at 5 years PMID 34895479 ↗
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dacarbazine | Small molecule | 250 mg/m2 | Intravenous |
| Comparator | procarbazine | Small molecule | 100 mg/m2 | Oral |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Prednisolone | Other / unclassified | — | Oral |
| Background | Prednisone | Other / unclassified | 40 mg/m2 | Oral |
| Background | Prednisone | Other / unclassified | 60 mg/m2 | Oral |
| Background | Vincristine | Small molecule | 1.5 mg/m2 | Intravenous |