HD21 for Advanced Stages

Summary

Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy objective). If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment measured by treatment related morbidity (TRMorbidity objective).

Timeline

Start

2016-07

Primary completion

2022-12

Completion

2025-09

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.
• Ferdinandus J, Kaul H, Fossa A, Huttmann A, Keil F, Ko YD, Hitz F, Schwarz M, Trenker C, Kerkhoff A, Staib P, Wille K, Dresel I, Hahn D, Hertenstein B, Moosmann P, Mey U, Balabanov S, Armytage T, Roncolato F, Hellmuth JC, Hertzberg M, Kobe C, Klapper W, Baues C, Eich HT, Kreissl S, Fuchs M, Jablonski J, Schneider G, Tharmaseelan H, Eichenauer DA, von Tresckow B, Borchmann P, Brockelmann PJ. Positron Emission Tomography-Guided Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, and Dexamethasone in Older Patients With Advanced-Stage Classic Hodgkin Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Cohort of the German Hodgkin Study Group HD21 Trial. J Clin Oncol. 2025 Sep 20;43(27):2974-2985. doi: 10.1200/JCO-25-00439. Epub 2025 Jul 17.
• Ferdinandus J, Schneider G, Moccia A, Greil R, Hertzberg M, Schaub V, Huttmann A, Keil F, Dierlamm J, Hanel M, Novak U, Meissner J, Hellmuth JC, Mathas S, Zijlstra JM, Fossa A, Viardot A, Hertenstein B, Martin S, Giri P, Kamper P, Molin D, Jablonski J, Damaschin C, Robertz AS, Rosenbrock J, Fuchs M, Borchmann P, Behringer K. Fertility in patients with advanced-stage classic Hodgkin lymphoma treated with BrECADD versus eBEACOPP: a secondary analysis of the multicentre, randomised, parallel, open-label, phase 3 HD21 trial. Lancet Oncol. 2025 Aug;26(8):1081-1090. doi: 10.1016/S1470-2045(25)00262-1. Epub 2025 Jul 10.
• 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.
• Borchmann P, Ferdinandus J, Schneider G, Moccia A, Greil R, Hertzberg M, Schaub V, Huttmann A, Keil F, Dierlamm J, Hanel M, Novak U, Meissner J, Zimmermann A, Mathas S, Zijlstra JM, Fossa A, Viardot A, Hertenstein B, Martin S, Giri P, Scholl S, Topp MS, Jung W, Vucinic V, Beck HJ, Kerkhoff A, Unger B, Rank A, Schroers R, Zum Buschenfelde CM, de Wit M, Trautmann-Grill K, Kamper P, Molin D, Kreissl S, Kaul H, von Tresckow B, Borchmann S, Behringer K, Fuchs M, Rosenwald A, Klapper W, Eich HT, Baues C, Zomas A, Hallek M, Dietlein M, Kobe C, Diehl V; German Hodgkin Study Group; Swiss Group for Clinical Cancer Research; Arbeitsgemeinschaft Medikamentose Tumortherapie; Nordic Lymphoma Group; Australasian Leukaemia and Lymphoma Group. Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21): a randomised, multicentre, parallel, open-label, phase 3 trial. Lancet. 2024 Jul 27;404(10450):341-352. doi: 10.1016/S0140-6736(24)01315-1. Epub 2024 Jul 3.

Drugs

Indications