drugset / Trial / NCT00515554
HD18 for Advanced Stages in Hodgkins Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is designed to test: 1. in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles) 2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS.
Timeline
- Start
- 2008-05
- Primary completion
- 2019-07
- Completion
- 2020-07
Publications
- Leiders S, Ufton D, Kaul H, Weindler J, Rosenbrock J, Fuchs M, Dietlein M, Novak U, Fehr M, Greil R, Hertzberg M, Zijlstra JM, Fossa A, Kamper P, Molin D, Borchmann P, Kobe C, Ferdinandus J. Validation of the newly introduced Deauville Score 5a in patients treated for advanced-stage classic Hodgkin Lymphoma. Blood Adv. 2026 Jun 30:bloodadvances.2026019712. doi: 10.1182/bloodadvances.2026019712. Online ahead of print.
- Lommen M, Weindler JJ, Jablonski J, Rosenbrock J, Borchmann P, Behringer K, Roth KS, Ufton D, Dietlein M, Kobe C, Ferdinandus J. Association between metabolic tumor burden and health-related quality of life in patients with classic Hodgkin lymphoma. Eur J Nucl Med Mol Imaging. 2026 Feb;53(3):1847-1855. doi: 10.1007/s00259-025-07569-5. Epub 2025 Oct 11.
- Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
- Kreissl S, Goergen H, Buehnen I, Kobe C, Moccia A, Greil R, Eichenauer DA, Zijlstra JM, Markova J, Meissner J, Feuring-Buske M, Soekler M, Beck HJ, Willenbacher W, Ludwig WD, Pabst T, Topp MS, Hitz F, Bentz M, Keller UB, Kuhnhardt D, Ostermann H, Hertenstein B, Aulitzky W, Maschmeyer G, Vieler T, Eich H, Baues C, Stein H, Fuchs M, Diehl V, Dietlein M, Engert A, Borchmann P; German Hodgkin Study Group. PET-guided eBEACOPP treatment of advanced-stage Hodgkin lymphoma (HD18): follow-up analysis of an international, open-label, randomised, phase 3 trial. Lancet Haematol. 2021 Jun;8(6):e398-e409. doi: 10.1016/S2352-3026(21)00101-0.
- Kobe C, Goergen H, Baues C, Kuhnert G, Voltin CA, Zijlstra J, Hoekstra O, Mettler J, Drzezga A, Engert A, Borchmann P, Dietlein M. Outcome-based interpretation of early interim PET in advanced-stage Hodgkin lymphoma. Blood. 2018 Nov 22;132(21):2273-2279. doi: 10.1182/blood-2018-05-852129. Epub 2018 Aug 30.
- Voltin CA, Goergen H, Baues C, Fuchs M, Mettler J, Kreissl S, Oertl J, Klaeser B, Moccia A, Drzezga A, Engert A, Borchmann P, Dietlein M, Kobe C. Value of bone marrow biopsy in Hodgkin lymphoma patients staged by FDG PET: results from the German Hodgkin Study Group trials HD16, HD17, and HD18. Ann Oncol. 2018 Sep 1;29(9):1926-1931. doi: 10.1093/annonc/mdy250.
- Borchmann P, Goergen H, Kobe C, Lohri A, Greil R, Eichenauer DA, Zijlstra JM, Markova J, Meissner J, Feuring-Buske M, Huttmann A, Dierlamm J, Soekler M, Beck HJ, Willenbacher W, Ludwig WD, Pabst T, Topp MS, Hitz F, Bentz M, Keller UB, Kuhnhardt D, Ostermann H, Schmitz N, Hertenstein B, Aulitzky W, Maschmeyer G, Vieler T, Eich H, Baues C, Stein H, Fuchs M, Kuhnert G, Diehl V, Dietlein M, Engert A. PET-guided treatment in patients with advanced-stage Hodgkin's lymphoma (HD18): final results of an open-label, international, randomised phase 3 trial by the German Hodgkin Study Group. Lancet. 2017 Dec 23;390(10114):2790-2802. doi: 10.1016/S0140-6736(17)32134-7. Epub 2017 Oct 20.
- Borchmann P, Haverkamp H, Lohri A, Mey U, Kreissl S, Greil R, Markova J, Feuring-Buske M, Meissner J, Duhrsen U, Ostermann H, Keller U, Maschmeyer G, Kuhnert G, Dietlein M, Kobe C, Eich H, Baues C, Stein H, Fuchs M, Diehl V, Engert A. Progression-free survival of early interim PET-positive patients with advanced stage Hodgkin's lymphoma treated with BEACOPPescalated alone or in combination with rituximab (HD18): an open-label, international, randomised phase 3 study by the German Hodgkin Study Group. Lancet Oncol. 2017 Apr;18(4):454-463. doi: 10.1016/S1470-2045(17)30103-1. Epub 2017 Feb 22.
- Sauer M, Plutschow A, Jachimowicz RD, Kleefisch D, Reiners KS, Ponader S, Engert A, von Strandmann EP. Baseline serum TARC levels predict therapy outcome in patients with Hodgkin lymphoma. Am J Hematol. 2013 Feb;88(2):113-5. doi: 10.1002/ajh.23361. Epub 2012 Dec 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bleomycin | Unknown | 10 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 1250 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 35 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 40 mg/m2 | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | procarbazine | Small molecule | 100 mg/m2 | Oral |