Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1500 participants
INTERVENTIONAL
2016-07-31
2025-09-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BEACOPP
4 or 6 cycles of BEACOPP (21-day cycles) Bleomycin (B) Etoposide (E) Doxorubicin (A) Cyclophosphamide (C) Vincristine (O) Procarbazin (P) Prednisone (P). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will bev given a total of six cycles.
Bleomycin
Etoposide
Doxorubicin
Cyclophosphamide
Vincristine
Procarbazine
Prednisone
BRECADD
4 or 6 cycles of BRECADD (21.day cycles) Brentuximab Vedotin (BR) Etoposide (E) Cyclophosphamide (C) Doxorubicin (A) Dacarbazine (D) Dexamethasone (D). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will be given a total of six cycles.
Etoposide
Doxorubicin
Cyclophosphamide
Brentuximab Vedotin
Dacarbazine
Dexamethasone
Interventions
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Bleomycin
Etoposide
Doxorubicin
Cyclophosphamide
Vincristine
Procarbazine
Prednisone
Brentuximab Vedotin
Dacarbazine
Dexamethasone
Eligibility Criteria
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Inclusion Criteria
* First diagnosis, no previous treatment, 18 to 60 years of age
* Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV
Exclusion Criteria
* Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
* Prior chemotherapy or radiotherapy
18 Years
60 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Prof. Dr. Peter Borchmann
Prof.
Principal Investigators
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Peter Borchmann, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Cologne, I. Dept. of Medicine
Locations
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University Hospital of Cologne
Cologne, , Germany
Countries
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References
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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.
Other Identifiers
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2014-005130-55
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Uni-Koeln-1762
Identifier Type: -
Identifier Source: org_study_id
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